Rheumatoid ArthritisPhase 2NCT00147498
Three Dose Levels of CP-690,550 Monotherapy Versus Placebo, Administered Orally Twice Daily (BID) for 6 Weeks
A Phase 2 study testing CP-690,550 in people with Rheumatoid Arthritis, run by Pfizer at 60 sites in 9 countries.
Trial summary
The study's objective is to compare the efficacy of 3 dose levels of oral CP-690,550 monotherapy (5 mg, 15 mg, and 30 mg twice daily [BID]) versus placebo administered over 6 weeks for the treatment of the signs and symptoms of subjects with active rheumatoid arthritis (RA). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- CP-690,550
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 60 sitesin 9 countries
- Study dates
- Jan 2005to Jun 2006
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has a history of inadequate response to at least 1, but no more than 4, of the following DMARDs: sulfasalazine, injectable gold, methotrexate, leflunomide, cyclosporine, or a thiopurine derivative (azathioprine or 6-mercaptopurine)
Who cannot join
- Current Therapy With Any DMARD Or Biologic
Trial locations and contacts
60 sites in 9 countries.
60 sites in 9 countries
United States24 sites
Pfizer Investigational Site
Charleston, South Carolina, 29406
Pfizer Investigational Site
Charlotte, North Carolina, 28210
Pfizer Investigational Site
Clearwater, Florida, 33765
Pfizer Investigational Site
Columbia, South Carolina, 29204
Pfizer Investigational Site
Concord, New Hampshire, 03301
Pfizer Investigational Site
Dallas, Texas, 75231-4496
Pfizer Investigational Site
Dayton, Ohio, 45402
Pfizer Investigational Site
Dubuque, Iowa, 52001-7313
Pfizer Investigational Site
Dubuque, Iowa, 52002
Pfizer Investigational Site
Ducansville, Pennsylvania, 16635
Pfizer Investigational Site
Everett, Washington, 98201
Pfizer Investigational Site
Hickory, North Carolina, 28601
Pfizer Investigational Site
Hickory, North Carolina, 28602
Pfizer Investigational Site
Johnstown, Pennsylvania, 15904
Pfizer Investigational Site
Miami, Florida, 33173
Pfizer Investigational Site
Nashville, Tennessee, 37203
Pfizer Investigational Site
New Port Richey, Florida, 34652
Pfizer Investigational Site
Ocala, Florida, 34474-7455
Pfizer Investigational Site
Orlando, Florida, 32804
Pfizer Investigational Site
Plainview, New York, 11803
Pfizer Investigational Site
Port Richey, Florida, 34668
Pfizer Investigational Site
Tacoma, Washington, 98405
Pfizer Investigational Site
Tampa, Florida, 33614
Pfizer Investigational Site
Upland, California, 91786
Germany8 sites
Pfizer Investigational Site
Berlin, 10098
Pfizer Investigational Site
Dresden, 01067
Pfizer Investigational Site
Hamburg, 22081
Pfizer Investigational Site
Hildesheim, 31134
Pfizer Investigational Site
Leipzig, 04103
Pfizer Investigational Site
München, 80639
Pfizer Investigational Site
Neubrandenburg, 17033
Pfizer Investigational Site
Wiesbaden, 65191
Spain6 sites
Pfizer Investigational Site
Barcelona, Barcelona, 08003
Pfizer Investigational Site
Guadalajara, Guadalajara, 19002
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, 08907
Pfizer Investigational Site
Madrid, Madrid, 28046
Pfizer Investigational Site
Santiago de Compostela, La Coruña, 15706
Pfizer Investigational Site
Seville, Sevilla, 41014
Brazil5 sites
Pfizer Investigational Site
Curitiba, Paraná, 80060-240
Pfizer Investigational Site
Goiânia, Goiás, 74043-110
Pfizer Investigational Site
Goiânia, Goiás, 74110-120
Pfizer Investigational Site
São Paulo, São Paulo, 04230-000
Pfizer Investigational Site
São Paulo, São Paulo, 05001-000
Canada5 sites
Pfizer Investigational Site
Edmonton, Alberta, T5M 0H4
Pfizer Investigational Site
London, Ontario, N6A 4V2
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, A1C 5B8
Pfizer Investigational Site
Toronto, Ontario, M5T 2S8
Pfizer Investigational Site
Victoria, British Columbia, V8P 5P6
Mexico5 sites
Pfizer Investigational Site
Aguascalientes, Aguascalientes, 20230
Pfizer Investigational Site
Guadalajara, Jalisco, 44690
Pfizer Investigational Site
México, D.f., 06726
Pfizer Investigational Site
San Luis Potosí City, San Luis Potosí, 78240
Pfizer Investigational Site
Tlalpan Seccion 16, Mexico City, 14000
Italy3 sites
Pfizer Investigational Site
Florence, 50139
Pfizer Investigational Site
Genova, 16132
Pfizer Investigational Site
Pavia, 27100
Slovakia3 sites
Pfizer Investigational Site
Košice, 040 11
Pfizer Investigational Site
Piešťany, 921 01
Pfizer Investigational Site
Žilina, 012 07
About this study
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Compare 3 Dose Levels Of CP-690,550 Versus Placebo, Administered Orally Twice Daily (BID) For 6 Weeks, In The Treatment Of The Signs And Symptoms Of Subjects With Active Rheumatoid Arthritis
The study's objective is to compare the efficacy of 3 dose levels of oral CP-690,550 monotherapy (5 mg, 15 mg, and 30 mg twice daily [BID]) versus placebo administered over 6 weeks for the treatment of the signs and symptoms of subjects with active rheumatoid arthritis (RA).
- Conditions
- Rheumatoid Arthritis
- Being tested
- CP-690,550, Placebo
- Keywords
- oral JAK inhibitor, clinical trial, joint diseases, anti-Inflammatory agents, rheumatic diseases, DMARD, Antirheumatic Agents, Autoimmune Diseases, Immune System Diseases
- Medical subject headings
- Arthritis, Rheumatoid, Joint Diseases, Rheumatic Diseases, Autoimmune Diseases, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-690,550Drug
Oral tablets administered at a dose of 5 mg BID for 6 weeks
CP-690,550Drug
Oral tablets administered at a dose of 15 mg BID for 6 weeks
CP-690,550Drug
30 mg BID for 6 weeks
PlaceboOther
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| 5 mg BID | Experimental | CP 690,550 5 mg BID Receives: Drug: CP-690,550 |
| 15 mg BID | Experimental | CP 690,550 15 mg BID Receives: Drug: CP-690,550 |
| 30 mg BID | Experimental | Oral tablets administered at a dose of 30 mg BID for 6 weeks Receives: Drug: CP-690,550 |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6
ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Measured: Week 6
Secondary outcomes (21)
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
ACR20 response: >=20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Measured: Week 1, 2, 4, and 8
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Measured: Week 1, 2, 4, 6, and 8
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
ACR70 response: >= 70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Measured: Week 1, 2, 4, 6, and 8
Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve
ACR-n: calculated by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The area under the curve (AUC) for ACR-n is the measure of the AUC of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.
Measured: Baseline up to Week 6
Tender Joints Count (TJC)
Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.
Measured: Baseline, Week 1, 2, 4, 6, and 8
Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8
Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicated an improvement.
Measured: Baseline, Week 1, 2, 4, 6, and 8
Swollen Joints Count (SJC)
Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.
Measured: Baseline, Week 1, 2, 4, 6, and 8
Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8
Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement.
Measured: Baseline, Week 1, 2, 4, 6, and 8
Patient Global Assessment (PtGA) of Arthritis
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 millimeter (mm) Visual Analog Scale (VAS) where 0 mm = very well and 100 mm = very poorly.
Measured: Baseline, Week 1, 2, 4, 6, and 8
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.
Measured: Baseline, Week 1, 2, 4, 6, and 8
Physician Global Assessment of Arthritis
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Measured: Baseline, Week 1, 2, 4, 6, and 8
Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Measured: Baseline, Week 1, 2, 4, 6, and 8
Patient Assessment of Arthritis Pain
Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
Measured: Baseline, Week 1, 2, 4, 6, and 8
Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8
Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
Measured: Baseline, Week 1, 2, 4, 6, and 8
Health Assessment Questionnaire-Disability Index (HAQ-DI)
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Measured: Baseline, Week 1, 2, 4, 6, and 8
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Measured: Baseline, Week 1, 2, 4, 6, and 8
C-Reactive Protein (CRP)
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 100 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Measured: Baseline, Week 1, 2, 4, 6, and 8
Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 mg/L to 100 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Measured: Baseline, Week 1, 2, 4, 6, and 8
Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score ranging 0 to 9.4; higher scores indicated greater affectation due to disease activity. DAS 28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and less than (<) 2.6 = remission.
Measured: Baseline, Week 1, 2, 4, 6, and 8
Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score ranging 0 to 9.4; higher scores indicated greater affectation due to disease activity. DAS 28-3 (CRP) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and <2.6 = remission.
Measured: Baseline, Week 1, 2, 4, 6, and 8
Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)
Disease improvement was classified as good, moderate, and no change based on improvement in DAS 28-3 (CRP) from baseline and present DAS 28-3 (CRP) score. Good: an improvement from baseline of >1.2 and a present score of <=3.2; none: an improvement of <=0.6 or >0.6 to <=1.2 with a present score of >5.1; remaining participants were classified as having moderate improvement. Scores of good and moderate were considered to have therapeutic response.
Measured: Baseline, Week 1, 2, 4, 6, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionJun 2006
- Study completionJun 2006
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 (14)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147498
- Sponsor's protocol ID
- A3921019
- Status last verified
- Dec 2012
- First submitted
- 2 Sep 2005
- Last updated
- 30 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wright G, Mysler E, Roberts KD, Shelbaya A, Sweet L, Masri KR. Impact of the Sociodemographic Index on Efficacy/Safety of Tofacitinib in Patients with Rheumatoid Arthritis: Post Hoc Analysis of Phase 2/3/3b/4 Studies. Rheumatol Ther. 2026 Oct 16. doi: 10.1007/s40744-026-00881-y. Online ahead of print.
PubMed 42888330Hetland ML, Strangfeld A, Bonfanti G, Soudis D, Deuring JJ, Edwards RA. Machine learning prediction and explanatory models of serious infections in patients with rheumatoid arthritis treated with tofacitinib. Arthritis Res Ther. 2024 Aug 27;26(1):153. doi: 10.1186/s13075-024-03376-9.
PubMed 39192350Wright GC, Mysler E, Kwok K, Cadatal MJ, Germino R, Yndestad A, Kinch CD, Ogdie A. Impact of Race on the Efficacy and Safety of Tofacitinib in Rheumatoid Arthritis: Post Hoc Analysis of Pooled Clinical Trials. Rheumatol Ther. 2024 Oct;11(5):1135-1164. doi: 10.1007/s40744-024-00677-y. Epub 2024 Jul 3.
PubMed 38958913Kristensen LE, Danese S, Yndestad A, Wang C, Nagy E, Modesto I, Rivas J, Benda B. Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance. Ann Rheum Dis. 2023 Jul;82(7):901-910. doi: 10.1136/ard-2022-223715. Epub 2023 Mar 17.
PubMed 36931693Hansen KE, Mortezavi M, Nagy E, Wang C, Connell CA, Radi Z, Litman HJ, Adami G, Rossini M. Fracture in clinical studies of tofacitinib in rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2022 Dec 27;14:1759720X221142346. doi: 10.1177/1759720X221142346. eCollection 2022.
PubMed 36601090Curtis JR, Yamaoka K, Chen YH, Bhatt DL, Gunay LM, Sugiyama N, Connell CA, Wang C, Wu J, Menon S, Vranic I, Gomez-Reino JJ. Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial. Ann Rheum Dis. 2023 Mar;82(3):331-343. doi: 10.1136/ard-2022-222543. Epub 2022 Dec 5.
PubMed 36600185Winthrop KL, Yndestad A, Henrohn D, Danese S, Marsal S, Galindo M, Woolcott JC, Jo H, Kwok K, Shapiro AB, Jones TV, Diehl A, Su C, Panes J, Cohen SB. Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs. Rheumatol Ther. 2023 Apr;10(2):357-373. doi: 10.1007/s40744-022-00507-z. Epub 2022 Dec 17.
PubMed 36526796Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.
PubMed 34870800Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.
PubMed 33127856Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.
PubMed 32816215Mariette X, Chen C, Biswas P, Kwok K, Boy MG. Lymphoma in the Tofacitinib Rheumatoid Arthritis Clinical Development Program. Arthritis Care Res (Hoboken). 2018 May;70(5):685-694. doi: 10.1002/acr.23421. Epub 2018 Apr 2.
PubMed 28941219Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.
PubMed 28143815Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.
PubMed 25047021Kremer JM, Bloom BJ, Breedveld FC, Coombs JH, Fletcher MP, Gruben D, Krishnaswami S, Burgos-Vargas R, Wilkinson B, Zerbini CA, Zwillich SH. The safety and efficacy of a JAK inhibitor in patients with active rheumatoid arthritis: Results of a double-blind, placebo-controlled phase IIa trial of three dosage levels of CP-690,550 versus placebo. Arthritis Rheum. 2009 Jul;60(7):1895-905. doi: 10.1002/art.24567.
PubMed 19565475
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Compare 3 Dose Levels Of CP-690,550 Versus Placebo, Administered Orally Twice Daily (BID) For 6 Weeks, In The Treatment Of The Signs And Symptoms Of Subjects With Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00147498
- Acronym / sponsor ID
- A3921019
- Conditions
- Rheumatoid Arthritis
- Keywords
- oral JAK inhibitor, clinical trial, joint diseases, anti-Inflammatory agents, rheumatic diseases, DMARD, Antirheumatic Agents, Autoimmune Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 7 Sep 2005 (estimated)
- Results
- Posted 30 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study's objective is to compare the efficacy of 3 dose levels of oral CP-690,550 monotherapy (5 mg, 15 mg, and 30 mg twice daily [BID]) versus placebo administered over 6 weeks for the treatment of the signs and symptoms of subjects with active rheumatoid arthritis (RA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5 mg BID | Experimental | Drug: CP-690,550CP 690,550 5 mg BID |
| 15 mg BID | Experimental | Drug: CP-690,550CP 690,550 15 mg BID |
| 30 mg BID | Experimental | Drug: CP-690,550Oral tablets administered at a dose of 30 mg BID for 6 weeks |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The subject has a history of inadequate response to at least 1, but no more than 4, of the following DMARDs: sulfasalazine, injectable gold, methotrexate, leflunomide, cyclosporine, or a thiopurine derivative (azathioprine or 6-mercaptopurine)
Key exclusion criteria (1 listed)
- Current Therapy With Any DMARD Or Biologic
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 |
|---|---|---|
| CP-690,550Oral tablets administered at a dose of 5 mg BID for 6 weeks | Drug | 5 mg BID |
| CP-690,550Oral tablets administered at a dose of 15 mg BID for 6 weeks | Drug | 15 mg BID |
| CP-690,55030 mg BID for 6 weeks | Drug | 30 mg BID |
| PlaceboPlacebo tablets | Other | Placebo |
Primary outcome
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6
Time frame: Week 6
ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
21 secondary outcomes
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
Time frame: Week 1, 2, 4, and 8
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Time frame: Week 1, 2, 4, 6, and 8
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Time frame: Week 1, 2, 4, 6, and 8
Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve
Time frame: Baseline up to Week 6
Tender Joints Count (TJC)
Time frame: Baseline, Week 1, 2, 4, 6, and 8
Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8
Time frame: Baseline, Week 1, 2, 4, 6, and 8
Swollen Joints Count (SJC)
Time frame: Baseline, Week 1, 2, 4, 6, and 8
Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8
Time frame: Baseline, Week 1, 2, 4, 6, and 8
Patient Global Assessment (PtGA) of Arthritis
Time frame: Baseline, Week 1, 2, 4, 6, and 8
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8
Time frame: Baseline, Week 1, 2, 4, 6, and 8
Physician Global Assessment of Arthritis
Time frame: Baseline, Week 1, 2, 4, 6, and 8
Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8
Time frame: Baseline, Week 1, 2, 4, 6, and 8
Patient Assessment of Arthritis Pain
Time frame: Baseline, Week 1, 2, 4, 6, and 8
Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8
Time frame: Baseline, Week 1, 2, 4, 6, and 8
Health Assessment Questionnaire-Disability Index (HAQ-DI)
Time frame: Baseline, Week 1, 2, 4, 6, and 8
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8
Time frame: Baseline, Week 1, 2, 4, 6, and 8
C-Reactive Protein (CRP)
Time frame: Baseline, Week 1, 2, 4, 6, and 8
Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8
Time frame: Baseline, Week 1, 2, 4, 6, and 8
Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
Time frame: Baseline, Week 1, 2, 4, 6, and 8
Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8
Time frame: Baseline, Week 1, 2, 4, 6, and 8
Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)
Time frame: Baseline, Week 1, 2, 4, 6, and 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42888330Wright G, Mysler E, Roberts KD, Shelbaya A, Sweet L, Masri KR. Impact of the Sociodemographic Index on Efficacy/Safety of Tofacitinib in Patients with Rheumatoid Arthritis: Post Hoc Analysis of Phase 2/3/3b/4 Studies. Rheumatol Ther. 2026 Oct 16. doi: 10.1007/s40744-026-00881-y. Online ahead of print.
- Derived from this study: PubMed 39192350Hetland ML, Strangfeld A, Bonfanti G, Soudis D, Deuring JJ, Edwards RA. Machine learning prediction and explanatory models of serious infections in patients with rheumatoid arthritis treated with tofacitinib. Arthritis Res Ther. 2024 Aug 27;26(1):153. doi: 10.1186/s13075-024-03376-9.
- Derived from this study: PubMed 38958913Wright GC, Mysler E, Kwok K, Cadatal MJ, Germino R, Yndestad A, Kinch CD, Ogdie A. Impact of Race on the Efficacy and Safety of Tofacitinib in Rheumatoid Arthritis: Post Hoc Analysis of Pooled Clinical Trials. Rheumatol Ther. 2024 Oct;11(5):1135-1164. doi: 10.1007/s40744-024-00677-y. Epub 2024 Jul 3.
- Derived from this study: PubMed 36931693Kristensen LE, Danese S, Yndestad A, Wang C, Nagy E, Modesto I, Rivas J, Benda B. Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance. Ann Rheum Dis. 2023 Jul;82(7):901-910. doi: 10.1136/ard-2022-223715. Epub 2023 Mar 17.
- Derived from this study: PubMed 36601090Hansen KE, Mortezavi M, Nagy E, Wang C, Connell CA, Radi Z, Litman HJ, Adami G, Rossini M. Fracture in clinical studies of tofacitinib in rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2022 Dec 27;14:1759720X221142346. doi: 10.1177/1759720X221142346. eCollection 2022.
- Derived from this study: PubMed 36600185Curtis JR, Yamaoka K, Chen YH, Bhatt DL, Gunay LM, Sugiyama N, Connell CA, Wang C, Wu J, Menon S, Vranic I, Gomez-Reino JJ. Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial. Ann Rheum Dis. 2023 Mar;82(3):331-343. doi: 10.1136/ard-2022-222543. Epub 2022 Dec 5.
- Derived from this study: PubMed 36526796Winthrop KL, Yndestad A, Henrohn D, Danese S, Marsal S, Galindo M, Woolcott JC, Jo H, Kwok K, Shapiro AB, Jones TV, Diehl A, Su C, Panes J, Cohen SB. Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs. Rheumatol Ther. 2023 Apr;10(2):357-373. doi: 10.1007/s40744-022-00507-z. Epub 2022 Dec 17.
- Derived from this study: PubMed 34870800Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.
- Derived from this study: PubMed 33127856Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.
- Derived from this study: PubMed 32816215Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.
- Derived from this study: PubMed 28941219Mariette X, Chen C, Biswas P, Kwok K, Boy MG. Lymphoma in the Tofacitinib Rheumatoid Arthritis Clinical Development Program. Arthritis Care Res (Hoboken). 2018 May;70(5):685-694. doi: 10.1002/acr.23421. Epub 2018 Apr 2.
- Derived from this study: PubMed 28143815Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
60 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CP-690,550 in people with Rheumatoid Arthritis, run by Pfizer at 60 sites in 9 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 1 inclusion and 1 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 30 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Germany, Spain, Brazil, Canada and 4 more countries. 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 30 Jan 2013). 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?
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6 (time frame: Week 6). 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 NCT00147498, which also lists 14 linked publications.
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 30 Jan 2013.