Rheumatoid ArthritisPhase 2Taski-2NCT00665925
Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis
A Phase 2 study testing Fostamatinib disodium (R935788) in people with Rheumatoid Arthritis, run by Rigel Pharmaceuticals at 65 sites in 6 countries.
Trial summary
The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) inhibitor, R935788 (R788), at a dose of 100 mg, orally, twice-a-day, and/or a dose of of 150 mg, orally, once-a-day is effective in the treatment of Rheumatoid Arthrits in patients who have had an inadequate clinical response to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Fostamatinib disodium (R935788)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 457 participants
- Where
- 65 sitesin 6 countries
- Study dates
- May 2008to Jun 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must give written informed consent by signing an IRB/EC-approved Informed Consent Form (ICF) prior to admission to this study.
- Males and females, 18 years of age or older, with active RA for at least 6 months prior to Day 1 dosing.
- Patients must have been receiving weekly methotrexate doses (7.5-25 mg/week) for a minimum of 3 months prior to Day 1 dosing and must be receiving a stable MTX dose, with no change in route, for the previous 6 weeks prior to Day 1 dosing.
- 'Patients must be receiving a folic or folinic acid supplementation at a stable dose for at least 6 weeks prior to Day 1 dosing.
- Females of childbearing potential must be fully informed of the potential for R788 to adversely affect the fetus and, if sexually active, must agree to use a well established method of birth control during the study (oral contraceptive, mechanical barrier, long acting hormonal agent). These patients must not be lactating and must have a negative urine pregnancy test at the time of randomization and at each laboratory determination.
- The patient must otherwise be in good health as determined by the Investigator on the basis of medical history, physical examination, and laboratory screening tests during the screening period. See exclusion criteria for specific exclusions.
- In the Investigator's opinion, the patient has the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the Investigator and to participate in, and to comply with, the requirements of the entire protocol.
Who cannot join
- The patient has a history of, or a concurrent, clinically significant illness, medical condition (other than arthritis) or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study. Specifically, excluded are patients with the following:
- uncontrolled or poorly controlled hypertension;
- other autoimmune disease (psoriatic arthritis, lupus, mixed connective disorder) or arthritis syndromes (gout, Lyme disease, Reiter's syndrome);
- recent (within past 2 months prior to Day 1 dosing) serious surgery or infectious disease;
- recent history (past 5 years prior to Day 1 dosing) of, or treatment for, a malignancy other than nonmelanomatous skin cancer, or any history of lymphoma;
- Hepatitis B ;
Show all 12Show fewer
- Hepatitis C ;
- interstitial pneumonitis or active pulmonary infection on chest x-ray;
- Tuberculosis (TB): the TB skin test should be negative.
- known laboratory abnormalities.
- The patient has a history of substance abuse, drug addiction or alcoholism. Patients may consume up to 4 units of alcohol per week; however, alcohol should be avoided in the 72 hours prior to lab assessments. Patients who cannot reliably comply with this should be excluded. A unit of alcohol is defined as the following: Beer=12 oz or 355 mL; wine = 5 oz or 148 mL; sweet dessert wine=3 oz or 89 mL; 80 proof distilled spirits= 1.5 oz or 44 mL.
- The patient has been treated previously treated with R788 under a different protocol.
Trial locations and contacts
65 sites in 6 countries.
65 sites in 6 countries
United States24 sites
Austin Rheumatology & Research
Austin, Texas, 78705
Rheumatology Associates
Charleston, South Carolina, 29407
Rheumatology Associates, SC
Chicago, Illinois, 60612
Center for Arthritis & Osteoporosis
Elizabethtown, Kentucky, 42701
Rheumatology Associates
Erie, Pennsylvania, 16508
Florida Medical Research Institute
Gainsville, Florida, 32607
The Osteoporosis & Clinical Trials Center
Hagerstown, Maryland, 21740
Arthritis & Osteoporosis Center, PC
Hamden, Connecticut, 06518
Divison of Rheumatology Allergy and Immunology
La Jolla, California, 92037
Fiechtner Research, Inc.
Lansing, Michigan, 48910
Paddock Park Clinical Research
Ocala, Florida, 34474
Health Research of Oklahoma
Oklahoma City, Oklahoma, 73103
Westroads Medical Group
Omaha, Nebraska, 68114
Jeffrey Poiley, MD
Orlando, Florida, 32804
Desert Medical Advances
Palm Desert, California, 92260
North Carolina Arthritis & Allergy Care Center
Raleigh, North Carolina, 27609
Arthritis Center of South Texas
San Antonio, Texas, 78232
Lovelace Scientific Resources
Sarasota, Florida, 34233
Memorial Medical Group Clinical Research Inst
South Bend, Indiana, 46601
Arthritis Northwest, PLLC
Spokane, Washington, 99204
Cynthia Morgan
Washington D.C., District of Columbia, 20003
Clinical Research Center of Reading, LLP
West Reading, Pennsylvania, 19611
Rheumatic Disease Associates
Willow Grove, Pennsylvania, 19090
Wake Forest University
Winston-Salem, North Carolina, 27157
Mexico11 sites
Christus Muguerza del Parque
Chihuahua City, Chihuahua, 31000
Hospital Inovamed , Torre Médica
Cuernavaca, Morelos, 62270
Instituto Jalisciense de Investigación Clínica
Guadalajara, Jalisco, 44100
Hospital Civil de Guadalajara "Fray Antonio A
Guadalajara, Jalisco, 44280
Hospital Aranda de la Parra
León, Guanajuato, 37000
Arké Estudios Clínicos S.A de C.V
México, D.f., 6700
Clínica para el Diagnostico y Tratamiento de
México, D.f., 6700
Hospital Ángeles Metropolitano
México, D.f., 6700
Hospital General de México
México, D.f., 6726
Centro Médico DALINDE
Mexico City, Mexico City, 6760
Centro de Investigacion Clinical de Morelia
Morelia, Michoacán
Poland11 sites
NZOZ Centrum Medyczne Artur Racewicz
Bialystok, 15-337
Szpit. Spec.Nr 1, Odz. Reumatol. i Reh.
Bytom, 41-902
Wojewodzki Szpital Zespolony Oddzial Reumatol
Elblag, 82-300
Mazowieckie Centrum Badan Klinicznych
Grodzisk Mazowiecki
Malopolskie Centrum Medyczne SC
Krakow, 30-510
Krakowskie Centrum Medyczne NZOZ
Krakow, 31-501
NZOZ Reumed
Lublin, 20-607
NZOZ "Nasz Lekarz"
Torun, 87-100
Synexus SCM
Wroclaw, 50-088
ASK Klinika Reumatologii i Chor. Wewn.
Wroclaw, 53-137
ZOZ w Zyradowie Oddzial Reumatologii
Zyradow, 96-300
Colombia9 sites
Centro de Reumatologia y Ortopedia
Barranquilla, Atlántico
Reumatologos del Caribe
Barranquilla, Atlántico
CIREEM
Bogota, Cundinamarca
Fundación Instituto de Reumatología
Bogota, Cundinamarca
Riesgo de Fractura S.A
Bogota, Cundinamarca
Private Office
Bogotá, Cundinamarca
Centro Medico Carlos Ardila Lulle
Bucaramanga, Santander Department
SERVIMED
Bucaramanga, Santander Department
Unidad Medica Torre Plaza
Medellín, Antioquia
Romania6 sites
CMI "Cristei R. Dorica"
Brăila, 810219
Spitalul Clinic "Sf. Maria" Med Int si Reumat
Bucharest, Sector 1, 11172
Spitalul de Urgenta al MAI Dr. D. Gerota
Bucharest, 021392
Spitalul Clinic Judetean de Urgenta Cluj Reum
Cluj-Napoca, Cluj, 400006
Spitalul Judetean "Dr. Fogolyan Kristol"
Sf. Gheorghe, 520064
Spitalul Clinic Judetean Sibiu
Sibiu, Sibiu County, 550245
Bulgaria4 sites
MHAT "Kaspela"
Plovdiv, PLO, 4002
MHAT Ruse
Rousse, 7002
MNTranspH "Tsar Boris Treti"
Sofia, Gsof
DCC "Sv. Anna" Sofia
Sofia, 1709
About this study
Official title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate
The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) inhibitor, R935788 (R788), at a dose of 100 mg, orally, twice-a-day, and/or a dose of of 150 mg, orally, once-a-day is effective in the treatment of Rheumatoid Arthrits in patients who have had an inadequate clinical response to methotrexate.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Fostamatinib disodium (R935788), Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fostamatinib disodium (R935788)Drug
Also called R935788
100 mg tablet, orally, twice-a-day
Fostamatinib disodium (R935788)Drug
Also called R935788
150 mg tablet, orally, once a day
PlaceboDrug
Placebo, orally, either once a day, or twice a day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | R788, 100 mg tablet, orally, twice-a-day Receives: Drug: Fostamatinib disodium (R935788) |
| 2 | Experimental | R788, 150 mg tablet, orally, once a day Receives: Drug: Fostamatinib disodium (R935788) |
| 3 | Placebo comparator | Placebo, orally, either once a day, or twice a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
American College of Rheumatology 20 (ACR20) Response at 6 Months
The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 months
Measured: 6 months
Secondary outcomes (80)
American College of Rheumatology 20 (ACR20) Response at 1 Week
The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 week
Measured: 1 week
American College of Rheumatology 20 (ACR20) Response at 2 Weeks
The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 weeks
Measured: 2 weeks
American College of Rheumatology 20 (ACR20) Response at 1 Month
The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 month
Measured: 1 month
American College of Rheumatology 20 (ACR20) Response at 6 Weeks
The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 weeks
Measured: 6 weeks
American College of Rheumatology 20 (ACR20) Response at 2 Months
The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 months
Measured: 2 months
American College of Rheumatology 20 (ACR20) Response at 3 Months
The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 3 months
Measured: 3 months
American College of Rheumatology 20 (ACR20) Response at 4 Months
The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 4 months
Measured: 4 months
American College of Rheumatology 20 (ACR20) Response at 5 Months
The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 5 months
Measured: 5 months
American College of Rheumatology 50 (ACR50) Response at 1 Week
The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 week
Measured: 1 week
American College of Rheumatology 50 (ACR50) Response at 2 Weeks
The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 weeks
Measured: 2 weeks
American College of Rheumatology 50 (ACR50) Response at 1 Month
The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 month
Measured: 1 month
American College of Rheumatology 50 (ACR50) Response at 6 Weeks
The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 weeks
Measured: 6 weeks
American College of Rheumatology 50 (ACR50) Response at 2 Months
The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 months
Measured: 2 months
American College of Rheumatology 50 (ACR50) Response at 3 Months
The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 3 months
Measured: 3 months
American College of Rheumatology 50 (ACR50) Response at 4 Months
The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 4 months
Measured: 4 months
American College of Rheumatology 50 (ACR50) Response at 5 Months
The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 5 months
Measured: 5 months
American College of Rheumatology 50 (ACR50) Response at 6 Months
The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 months
Measured: 6 months
American College of Rheumatology 70 (ACR70) Response at 1 Week
The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 week
Measured: 1 week
American College of Rheumatology 70 (ACR70) Response at 2 Weeks
The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 weeks
Measured: 2 weeks
American College of Rheumatology 70 (ACR70) Response at 1 Month
The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 month
Measured: 1 month
American College of Rheumatology 70 (ACR70) Response at 6 Weeks
The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 weeks
Measured: 6 weeks
American College of Rheumatology 70 (ACR70) Response at 2 Months
The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 months
Measured: 2 months
American College of Rheumatology 70 (ACR70) Response at 3 Months
The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 3 months
Measured: 3 months
American College of Rheumatology 70 (ACR70) Response at 4 Months
The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 4 months
Measured: 4 months
American College of Rheumatology 70 (ACR70) Response at 5 Months
The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 5 months
Measured: 5 months
American College of Rheumatology 70 (ACR70) Response at 6 Months
The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 months
Measured: 6 months
American College of Rheumatology Index of Improvement (ACRn) at 1 Week
The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 1 week of treatment
Measured: 1 week
American College of Rheumatology Index of Improvement (ACRn) at 2 Weeks
The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 2 weeks of treatment
Measured: 2 weeks
American College of Rheumatology Index of Improvement (ACRn) at 1 Month
The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 1 month of treatment
Measured: 1 month
American College of Rheumatology Index of Improvement (ACRn) at 6 Weeks
The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 6 weeks of treatment
Measured: 6 weeks
American College of Rheumatology Index of Improvement (ACRn) at 2 Months
The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 2 months of treatment
Measured: 2 months
American College of Rheumatology Index of Improvement (ACRn) at 3 Months
The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 3 months of treatment
Measured: 3 months
American College of Rheumatology Index of Improvement (ACRn) at 4 Months
The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 4 months of treatment
Measured: 4 months
American College of Rheumatology Index of Improvement (ACRn) at 5 Months
The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 5 months of treatment
Measured: 5 months
American College of Rheumatology Index of Improvement (ACRn) at 6 Months
The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 6 months of treatment
Measured: 6 months
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 1 Month
Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms
Measured: 1 month
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 2 Months
Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms
Measured: 2 months
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 3 Months
Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms
Measured: 3 months
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 4 Months
Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms
Measured: 4 months
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 5 Months
Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms
Measured: 5 months
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 6 Months
Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms
Measured: 6 months
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 1 Month
Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity
Measured: 1 month
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 2 Months
Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity
Measured: 2 months
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 3 Months
Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity
Measured: 3 months
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 4 Months
Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity
Measured: 4 months
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 5 Months
Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity
Measured: 5 months
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 6 Months
Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity
Measured: 6 months
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 1 Month
Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms
Measured: 1 month
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 2 Months
Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms
Measured: 2 months
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 3 Months
Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms
Measured: 3 months
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 4 Months
Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms
Measured: 4 months
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 5 Months
Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms
Measured: 5 months
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 6 Months
Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms
Measured: 6 months
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 1 Month
Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity
Measured: 1 month
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 2 Months
Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity
Measured: 2 months
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 3 Months
Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity
Measured: 3 months
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 4 Months
Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity
Measured: 4 months
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 5 Months
Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity
Measured: 5 months
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 6 Months
Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity
Measured: 6 months
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at 6 Months
Change from baseline in FACIT-F, which is a patient-reported 13-item questionnaire that assesses fatigue, calculated as the score at 6 months minus the score at baseline. The FACIT-F runs from 0 to 52 with lower scores indicating higher fatigue. A positive change from baseline indicates an improvement in fatigue after treatment.
Measured: Baseline to 6 months
Short Form Health Survey (SF-36) Physical Component Summary (PCS) at 6 Months
Change from baseline in the PCS of the SF-36 (which assesses health and wellbeing), calculated as the score at 6 months minus the score at baseline. The PCS ranges from 0 to 100 with 100 indicating the highest level of functioning possible. A positive change indicates an improvement in PCS after treatment
Measured: Baseline to 6 months
Short Form Health Survey (SF-36) Mental Component Summary (MCS) at 6 Months
Change from baseline in the MCS of the SF-36 (which assesses health and wellbeing), calculated as the score at 6 months minus the score at baseline. The MCS ranges from 0 to 100 with 100 indicating the highest level of functioning possible. A positive change indicates an improvement in MCS after treatment
Measured: Baseline to 6 months
Alanine Aminotransferase (ALT) >1.5x Upper Limit of Normal (ULN)
The number of participants with ALT (a test of liver function) values greater than 1.5 times the ULN
Measured: Any time between baseline and 6 months
Alanine Aminotransferase (ALT) >1.5-2x Upper Limit of Normal (ULN)
The number of participants with ALT (a test of liver function) values greater than 1.5 to 2 times the ULN
Measured: Any time between baseline and 6 months
Alanine Aminotransferase (ALT) >2-3x Upper Limit of Normal (ULN)
The number of participants with ALT (a test of liver function) values greater than 2 to 3 times the ULN
Measured: Any time between baseline and 6 months
Alanine Aminotransferase (ALT) >3x Upper Limit of Normal (ULN)
The number of participants with ALT (a test of liver function) values greater than 3 times the ULN
Measured: Any time between baseline and 6 months
Alanine Aminotransferase (ALT) >3-5x Upper Limit of Normal (ULN)
The number of participants with ALT (a test of liver function) values greater than 3 to 5 times the ULN
Measured: Any time between baseline and 6 months
Alanine Aminotransferase (ALT) >5-10x Upper Limit of Normal (ULN)
The number of participants with ALT (a test of liver function) values greater than 5 to 10 times the ULN
Measured: Any time between baseline and 6 months
Alanine Aminotransferase (ALT) >10x Upper Limit of Normal (ULN)
The number of participants with ALT (a test of liver function) values greater than 10 times the ULN
Measured: Any time between baseline and 6 months
Aspartate Aminotransferase (AST) >1.5x Upper Limit of Normal (ULN)
The number of participants with AST (a test of liver function) values greater than 1.5 times the ULN
Measured: Any time between baseline and 6 months
Aspartate Aminotransferase (AST) >1.5-2x Upper Limit of Normal (ULN)
The number of participants with AST (a test of liver function) values greater than 1.5-2 times the ULN
Measured: Any time between baseline and 6 months
Aspartate Aminotransferase (AST) >2-3x Upper Limit of Normal (ULN)
The number of participants with AST (a test of liver function) values greater than 2 to 3 times the ULN
Measured: Any time between baseline and 6 months
Aspartate Aminotransferase (AST) >3x Upper Limit of Normal (ULN)
The number of participants with AST (a test of liver function) values greater than 3 times the ULN
Measured: Any time between baseline and 6 months
Aspartate Aminotransferase (AST) >3-5x Upper Limit of Normal (ULN)
The number of participants with AST (a test of liver function) values greater than 3 to 5 times the ULN
Measured: Any time between baseline and 6 months
Aspartate Aminotransferase (AST) >5-10 x Upper Limit of Normal (ULN)
The number of participants with AST (a test of liver function) values greater than 5 to 10 times the ULN
Measured: Any time between baseline and 6 months
Aspartate Aminotransferase (AST) >10 x Upper Limit of Normal (ULN)
The number of participants with AST (a test of liver function) values greater than 10 times the ULN
Measured: Any time between baseline and 6 months
Alkaline Phosphatase >1.5 x Upper Limit of Normal (ULN) and >1.5 Times Baseline
The number of participants with alkaline phosphatase (a test of liver function) values greater than 1.5 times the ULN and greater than 1.5 times baseline
Measured: Any time between baseline and 6 months
Bilirubin >1.5 x Upper Limit of Normal (ULN)
The number of participants with bilirubin (a test of liver function) values greater than 1.5 times the ULN
Measured: Any time between baseline and 6 months
Bilirubin >2 x Upper Limit of Normal (ULN)
The number of participants with bilirubin (a test of liver function) values greater than 2 times the ULN
Measured: Any time between baseline and 6 months
Absolute Neutrophil Count (ANC) <1500/mm3
The number of participants with ANC (a test of liver function) values lower than 1500/mm3
Measured: Any time between baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rigel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel B Magilavy, MD, Study director, Rigel Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665925
- Sponsor's protocol ID
- C-935788-010
- Acronym
- Taski-2
- Status last verified
- Aug 2016
- First submitted
- 22 Apr 2008
- Last updated
- 16 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Weinblatt ME, Kavanaugh A, Genovese MC, Musser TK, Grossbard EB, Magilavy DB. An oral spleen tyrosine kinase (Syk) inhibitor for rheumatoid arthritis. N Engl J Med. 2010 Sep 30;363(14):1303-12. doi: 10.1056/NEJMoa1000500. Epub 2010 Sep 22.
PubMed 20879879
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate
- ClinicalTrials.gov ID
- NCT00665925
- Acronym / sponsor ID
- Taski-2 / C-935788-010
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- Rigel PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 24 Apr 2008 (estimated)
- Results
- Posted 13 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) inhibitor, R935788 (R788), at a dose of 100 mg, orally, twice-a-day, and/or a dose of of 150 mg, orally, once-a-day is effective in the treatment of Rheumatoid Arthrits in patients who have had an inadequate clinical response to methotrexate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fostamatinib disodium (R935788)R788, 100 mg tablet, orally, twice-a-day |
| 2 | Experimental | Drug: Fostamatinib disodium (R935788)R788, 150 mg tablet, orally, once a day |
| 3 | Placebo comparator | Drug: PlaceboPlacebo, orally, either once a day, or twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must give written informed consent by signing an IRB/EC-approved Informed Consent Form (ICF) prior to admission to this study.
- Males and females, 18 years of age or older, with active RA for at least 6 months prior to Day 1 dosing.
- Patients must have been receiving weekly methotrexate doses (7.5-25 mg/week) for a minimum of 3 months prior to Day 1 dosing and must be receiving a stable MTX dose, with no change in route, for the previous 6 weeks prior to Day 1 dosing.
- 'Patients must be receiving a folic or folinic acid supplementation at a stable dose for at least 6 weeks prior to Day 1 dosing.
- Females of childbearing potential must be fully informed of the potential for R788 to adversely affect the fetus and, if sexually active, must agree to use a well established method of birth control during the study (oral contraceptive, mechanical barrier, long acting hormonal agent). These patients must not be lactating and must have a negative urine pregnancy test at the time of randomization and at each laboratory determination.
Key exclusion criteria (12 listed)
- The patient has a history of, or a concurrent, clinically significant illness, medical condition (other than arthritis) or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study. Specifically, excluded are patients with the following:
- The patient has a history of substance abuse, drug addiction or alcoholism. Patients may consume up to 4 units of alcohol per week; however, alcohol should be avoided in the 72 hours prior to lab assessments. Patients who cannot reliably comply with this should be excluded. A unit of alcohol is defined as the following: Beer=12 oz or 355 mL; wine = 5 oz or 148 mL; sweet dessert wine=3 oz or 89 mL; 80 proof distilled spirits= 1.5 oz or 44 mL.
- The patient has been treated previously treated with R788 under a different protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fostamatinib disodium (R935788)Also: R935788100 mg tablet, orally, twice-a-day | Drug | 1 |
| Fostamatinib disodium (R935788)Also: R935788150 mg tablet, orally, once a day | Drug | 2 |
| PlaceboPlacebo, orally, either once a day, or twice a day | Drug | 3 |
Primary outcome
American College of Rheumatology 20 (ACR20) Response at 6 Months
Time frame: 6 months
The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 months
80 secondary outcomes
American College of Rheumatology 20 (ACR20) Response at 1 Week
Time frame: 1 week
American College of Rheumatology 20 (ACR20) Response at 2 Weeks
Time frame: 2 weeks
American College of Rheumatology 20 (ACR20) Response at 1 Month
Time frame: 1 month
American College of Rheumatology 20 (ACR20) Response at 6 Weeks
Time frame: 6 weeks
American College of Rheumatology 20 (ACR20) Response at 2 Months
Time frame: 2 months
American College of Rheumatology 20 (ACR20) Response at 3 Months
Time frame: 3 months
American College of Rheumatology 20 (ACR20) Response at 4 Months
Time frame: 4 months
American College of Rheumatology 20 (ACR20) Response at 5 Months
Time frame: 5 months
American College of Rheumatology 50 (ACR50) Response at 1 Week
Time frame: 1 week
American College of Rheumatology 50 (ACR50) Response at 2 Weeks
Time frame: 2 weeks
American College of Rheumatology 50 (ACR50) Response at 1 Month
Time frame: 1 month
American College of Rheumatology 50 (ACR50) Response at 6 Weeks
Time frame: 6 weeks
American College of Rheumatology 50 (ACR50) Response at 2 Months
Time frame: 2 months
American College of Rheumatology 50 (ACR50) Response at 3 Months
Time frame: 3 months
American College of Rheumatology 50 (ACR50) Response at 4 Months
Time frame: 4 months
American College of Rheumatology 50 (ACR50) Response at 5 Months
Time frame: 5 months
American College of Rheumatology 50 (ACR50) Response at 6 Months
Time frame: 6 months
American College of Rheumatology 70 (ACR70) Response at 1 Week
Time frame: 1 week
American College of Rheumatology 70 (ACR70) Response at 2 Weeks
Time frame: 2 weeks
American College of Rheumatology 70 (ACR70) Response at 1 Month
Time frame: 1 month
American College of Rheumatology 70 (ACR70) Response at 6 Weeks
Time frame: 6 weeks
American College of Rheumatology 70 (ACR70) Response at 2 Months
Time frame: 2 months
American College of Rheumatology 70 (ACR70) Response at 3 Months
Time frame: 3 months
American College of Rheumatology 70 (ACR70) Response at 4 Months
Time frame: 4 months
American College of Rheumatology 70 (ACR70) Response at 5 Months
Time frame: 5 months
American College of Rheumatology 70 (ACR70) Response at 6 Months
Time frame: 6 months
American College of Rheumatology Index of Improvement (ACRn) at 1 Week
Time frame: 1 week
American College of Rheumatology Index of Improvement (ACRn) at 2 Weeks
Time frame: 2 weeks
American College of Rheumatology Index of Improvement (ACRn) at 1 Month
Time frame: 1 month
American College of Rheumatology Index of Improvement (ACRn) at 6 Weeks
Time frame: 6 weeks
American College of Rheumatology Index of Improvement (ACRn) at 2 Months
Time frame: 2 months
American College of Rheumatology Index of Improvement (ACRn) at 3 Months
Time frame: 3 months
American College of Rheumatology Index of Improvement (ACRn) at 4 Months
Time frame: 4 months
American College of Rheumatology Index of Improvement (ACRn) at 5 Months
Time frame: 5 months
American College of Rheumatology Index of Improvement (ACRn) at 6 Months
Time frame: 6 months
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 1 Month
Time frame: 1 month
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 2 Months
Time frame: 2 months
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 3 Months
Time frame: 3 months
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 4 Months
Time frame: 4 months
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 5 Months
Time frame: 5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20879879Weinblatt ME, Kavanaugh A, Genovese MC, Musser TK, Grossbard EB, Magilavy DB. An oral spleen tyrosine kinase (Syk) inhibitor for rheumatoid arthritis. N Engl J Med. 2010 Sep 30;363(14):1303-12. doi: 10.1056/NEJMoa1000500. Epub 2010 Sep 22.
- Individual participant dataSharing planned: No
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel B Magilavy, MD study director
Rigel Pharmaceuticals
65 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fostamatinib disodium (R935788) in people with Rheumatoid Arthritis, run by Rigel Pharmaceuticals at 65 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, Mexico, Poland, Colombia, Romania and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American College of Rheumatology 20 (ACR20) Response at 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00665925, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2016.