Rheumatoid ArthritisPhase 3SUNRISENCT00266227
A Study of Retreatment With Rituximab in Patients With Rheumatoid Arthritis Receiving Background Methotrexate
A Phase 3 study testing rituximab, methotrexate and folate in people with Rheumatoid Arthritis, run by Genentech, Inc..
Trial summary
This is a Phase III, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy of retreatment with rituximab in subjects with active rheumatoid arthritis (RA) who are receiving Methotrexate (MTX). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- rituximab, methotrexate and folate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 559 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Oct 2007
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form
- Ability and willingness to comply with the requirements of the study protocol
- Age 18-80 years
- Diagnosis of RA for at least 6 months
- Receiving treatment for RA on an outpatient basis
- Documented moderate to severe active RA activity at screening and Day 1
Show all 12Show fewer
- Documented inadequate response to previous or current treatment with one or more of the following: etanercept, infliximab, and/or adalimumab because of toxicity or inadequate efficacy
- Use of MTX 10-25 mg/wk for ≥ 12 weeks prior to Day 1 at a stable dose for ≥ 4 weeks
- Willingness to receive oral folic acid
- If taking a background corticosteroid, use of the corticosteroid must be at a stable dose during the 4 weeks prior to Day 1
- Use of one NSAID is permitted if the dose is stable for ≥ 2 weeks prior to Day 1
- For men and women of reproductive potential, willingness to use a reliable means of contraception for ≥ 30 days prior to Day 1 and for the study duration or the duration that the subject's peripheral CD19 B cells are depleted, whichever is longer
Who cannot join
- Rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA; Secondary Sjogren's syndrome with RA is permitted.
- History of or current inflammatory joint disease other than RA or other systemic rheumatic disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, or overlap syndrome)
- History of deep space/tissue infection within 52 weeks prior to Day 1
- Diagnosis of juvenile idiopathic arthritis (JIA), juvenile rheumatoid arthritis (JRA), and/or RA before age 16
- Functional Class IV, as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
- Any surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement), within 12 weeks prior to Day 1 or planned within 48 weeks after Day 1
Show all 30Show fewer
- Known hypersensitivity to any component of a humanized or murine monoclonal antibody
- Receipt of any vaccination within 4 weeks prior to Day 1
- Significant cardiac or pulmonary disease, including obstructive pulmonary disease
- Evidence of significant uncontrolled concomitant disease, such as, but not limited to nervous system, renal, hepatic, endocrine, or gastrointestinal disorders
- Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease but excluding fungal infections of the nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of Day 1 or oral antibiotics within 2 weeks of Day 1
- History of serious recurrent or chronic infection (a chest X-ray will be performed at screening if one has not been performed within 12 weeks of screening that showed no clinically significant abnormality)
- History of or currently active primary or secondary immunodeficiency, including HIV infection
- History of cancer, including solid tumors and hematologic malignancies (except basal cell or squamous cell carcinoma of the skin that has been excised and cured)
- History of significant cytopenias or other bone marrow disorders
- History of alcohol, drug, or chemical abuse within 24 weeks prior to Day 1
- Pregnancy or lactation
- Neuropathies and neurovasculopathies that might interfere with pain evaluation
- Poor peripheral venous access
- Intolerance or contraindications to oral or IV corticosteroids
- Positive hepatitis B surface antigen or hepatitis C antibody serology
- For women of childbearing potential (including those who have had a tubal ligation), a positive serum pregnancy test at screening
- Current use of any DMARD other than MTX
- Concurrent treatment with any biologic agent
- Treatment with any investigational agent within 4 weeks prior to Day 1 or five half-lives of the investigational drug (whichever is longer)
- Any previous treatment with rituximab or other cell-depleting therapies, including CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19, anti-CD11a, anti-CD22, anti-BLys/ BAFF, and other anti-CD20 agents
- Previous treatment with a co-stimulation blocking agent, including abatacept
- Previous treatment with an anti-<alpha> 4 integrin agent, including natalizumab
- Previous treatment within 6 months of screening with IV \& globulin or the Prosorba(R) Column
- Intra-articular or parenteral corticosteroids within 4 weeks prior to Day 1
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Retreatment With Rituximab in Subjects With Rheumatoid Arthritis Receiving Background Methotrexate
This is a Phase III, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy of retreatment with rituximab in subjects with active rheumatoid arthritis (RA) who are receiving Methotrexate (MTX).
- Conditions
- Rheumatoid Arthritis
- Being tested
- placebo, rituximab, methotrexate, folate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Intravenous repeating dose
rituximabDrug
Intravenous repeating dose
methotrexateDrug
Oral or parenteral repeating dose
folateDrug
Intravenous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Rituximab Retreatment | Experimental | 1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate. Receives: Drug: rituximab; Drug: methotrexate; Drug: folate |
| Arm B: Placebo Retreatment | Placebo comparator | 1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by retreatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/week methotrexate. Receives: Drug: placebo; Drug: methotrexate; Drug: folate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retreated Subjects With an American College of Rheumatology 20% (ACR20) Response at Week 48 Relative to Baseline
ACR20 response was defined as a ≥ 20% improvement compared with baseline in both tender joint count (TJC) [68 joints] and swollen joint count (SJC) [66 joints] as well as a ≥ 20% improvement in three of five additional measurements: 1) Physician's Global Assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [visual analog scale: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [visual analog scale: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) erythrocyte sedimentation rate.
Measured: 48 Weeks
Secondary outcomes (19)
Retreated Subjects With American College of Rheumatology 50% (ACR50) Response and American College of Rheumatology 70% (ACR70) Response at Week 48 Relative to Baseline
ACR50 or ACR70 response was defined as a ≥ 50% or 70% improvement compared with baseline in both tender joint count (TJC) [68 joints] and swollen joint count (SJC) [66 joints] as well as a ≥ 50% or 70% improvement in three of five additional measurements: 1) Physician's Global Assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [visual analog scale: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [visual analog scale: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) erythrocyte sedimentation rate.
Measured: Baseline, Week 48
Change From Baseline in the Disease Activity Score Using 28 Joint Counts (DAS28-ESR) at Week 48
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
Measured: 48 weeks
Change From Baseline in Disease Activity Score (DAS28-CRP) at Week 48
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and C-Reactive Protein (CRP) for a total possible score of 2 to 10. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
Measured: Baseline, Week 48
Percentage of Retreated Subjects With a European League Against Rheumatism (EULAR) Response at Week 48
Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.
Measured: Baseline, Week 48
Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Swollen Joint Count at Week 48
A Rheumatologist or an skilled arthritis assessor evaluated 66 joints at baseline and at Week 48. A negative change from baseline in Swollen Joint Count indicates improvement.
Measured: Baseline, Week 48
Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Tender Joint Count at Week 48
A Rheumatologist or an skilled arthritis assessor evaluated 68 joints at baseline and at Week 48. A negative change from baseline in the Tender Joint Count indicates improvement.
Measured: Baseline, Week 48
Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 48
The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip,and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A negative change from baseline indicates improvement.
Measured: Baseline, Week 48
Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Subject's Global Assessment of Disease Activity at Week 48
Participants rated their disease activity at baseline and Week 48 using the Visual Analog Scale (VAS) on a scale of 0 (best) to 100 (worse). A negative change from baseline indicates improvement.
Measured: Baseline, Week 48
Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Physician's Global Assessment of Disease Activity at Week 48
A Rheumatologist or a skilled Arthritis assessor rated the patient's disease activity at baseline and Week 48 using the Visual Analog Scale (VAS) on a scale of 0 (best) to 100 (worse). A negative change from baseline indicates improvement.
Measured: Baseline, Week 48
Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Subject's Assessment of Pain at Week 48
Patients rated their pain at baseline and Week 48 using the Visual Analog Scale (VAS) on a scale of 0 (none) to 100 (unbearable pain). A negative change from baseline indicates improvement.
Measured: Baseline, Week 48
Change From Baseline in American College of Rheumatology (ACR) Core Set Component: C-Reactive Protein at Week 48
Blood was collected for C-Reactive Protein, an inflammatory marker, at Baseline and Week 48. A negative change from baseline indicates improvement.
Measured: Baseline, Week 48
Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Erythrocyte Sedimentation (ESR) at Week 48
Blood was collected for Erythrocyte Sedimentation Rate, an inflammatory marker, at Baseline and Week 48. A negative change from baseline indicates improvement.
Measured: Baseline, Week 48
Percentage of Retreated Subjects With a Change ≥ 0.22 From Baseline in HAQ-DI at Week 48
The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do). HAQ-DI=sum of worst scores in each domain divided by the number of domains answered.
Measured: Baseline, Week 48
Percentage of Retreated Subjects With a Change ≥ 0.3 From Baseline in HAQ-DI at Week 48
The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered.
Measured: Baseline, Week 48
ACRn in Retreated Subjects at Week 48
The ACRn is calculated for each participant by taking the lowest percentage improvement in (1) swollen joint count or (2) tender joint count 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). A positive ACRn Score indicates an improvement.
Measured: Baseline, Week 48
Change From Baseline in SF-36 Health Summary Scores at Week 48 in Retreated Subjects
The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.
Measured: Baseline, Week 48
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) at Week 48 in Retreated Subjects
FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.
Measured: Baseline, Week 48
Percentage of Retreated Subjects Achieving DAS28-ESR Remission at Week 48
DAS28-ESR remission was defined as a DAS28-ESR < 2.6
Measured: Week 48
Percentage of Retreated Subjects Achieving DAS28-ESR Low Disease at Week 48
The DAS28-ESR score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28-ESR scores range from 0 - 10. Low disease activity is defined as achieving a DAS28-ESR score of less than or equal to 3.2.
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2005 (estimated)
- Study startJan 2006
- Primary completionOct 2007
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.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 559 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anshu Vashishtha, MD PhD, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266227
- Sponsor's protocol ID
- U3384g
- Acronym
- SUNRISE
- Status last verified
- Sep 2013
- First submitted
- 14 Dec 2005
- Last updated
- 25 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Retreatment With Rituximab in Subjects With Rheumatoid Arthritis Receiving Background Methotrexate
- ClinicalTrials.gov ID
- NCT00266227
- Acronym / sponsor ID
- SUNRISE / U3384g
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 559 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Oct 2007 (actual)
- First posted
- 16 Dec 2005 (estimated)
- Results
- Posted 25 May 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase III, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy of retreatment with rituximab in subjects with active rheumatoid arthritis (RA) who are receiving Methotrexate (MTX).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Rituximab Retreatment | Experimental | Drug: rituximab, Drug: methotrexate, Drug: folate1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate. |
| Arm B: Placebo Retreatment | Placebo comparator | Drug: placebo, Drug: methotrexate, Drug: folate1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by retreatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/week methotrexate. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed informed consent form
- Ability and willingness to comply with the requirements of the study protocol
- Age 18-80 years
- Diagnosis of RA for at least 6 months
- Receiving treatment for RA on an outpatient basis
Key exclusion criteria (30 listed)
- Rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA; Secondary Sjogren's syndrome with RA is permitted.
- History of or current inflammatory joint disease other than RA or other systemic rheumatic disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, or overlap syndrome)
- History of deep space/tissue infection within 52 weeks prior to Day 1
- Diagnosis of juvenile idiopathic arthritis (JIA), juvenile rheumatoid arthritis (JRA), and/or RA before age 16
- Functional Class IV, as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
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 |
|---|---|---|
| placeboIntravenous repeating dose | Drug | Arm B: Placebo Retreatment |
| rituximabIntravenous repeating dose | Drug | Arm A: Rituximab Retreatment |
| methotrexateOral or parenteral repeating dose | Drug | Arm A: Rituximab Retreatment, Arm B: Placebo Retreatment |
| folateIntravenous repeating dose | Drug | Arm A: Rituximab Retreatment, Arm B: Placebo Retreatment |
Primary outcome
Retreated Subjects With an American College of Rheumatology 20% (ACR20) Response at Week 48 Relative to Baseline
Time frame: 48 Weeks
ACR20 response was defined as a ≥ 20% improvement compared with baseline in both tender joint count (TJC) [68 joints] and swollen joint count (SJC) [66 joints] as well as a ≥ 20% improvement in three of five additional measurements: 1) Physician's Global Assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [visual analog scale: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [visual analog scale: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) erythrocyte sedimentation rate.
19 secondary outcomes
Retreated Subjects With American College of Rheumatology 50% (ACR50) Response and American College of Rheumatology 70% (ACR70) Response at Week 48 Relative to Baseline
Time frame: Baseline, Week 48
Change From Baseline in the Disease Activity Score Using 28 Joint Counts (DAS28-ESR) at Week 48
Time frame: 48 weeks
Change From Baseline in Disease Activity Score (DAS28-CRP) at Week 48
Time frame: Baseline, Week 48
Percentage of Retreated Subjects With a European League Against Rheumatism (EULAR) Response at Week 48
Time frame: Baseline, Week 48
Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Swollen Joint Count at Week 48
Time frame: Baseline, Week 48
Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Tender Joint Count at Week 48
Time frame: Baseline, Week 48
Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 48
Time frame: Baseline, Week 48
Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Subject's Global Assessment of Disease Activity at Week 48
Time frame: Baseline, Week 48
Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Physician's Global Assessment of Disease Activity at Week 48
Time frame: Baseline, Week 48
Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Subject's Assessment of Pain at Week 48
Time frame: Baseline, Week 48
Change From Baseline in American College of Rheumatology (ACR) Core Set Component: C-Reactive Protein at Week 48
Time frame: Baseline, Week 48
Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Erythrocyte Sedimentation (ESR) at Week 48
Time frame: Baseline, Week 48
Percentage of Retreated Subjects With a Change ≥ 0.22 From Baseline in HAQ-DI at Week 48
Time frame: Baseline, Week 48
Percentage of Retreated Subjects With a Change ≥ 0.3 From Baseline in HAQ-DI at Week 48
Time frame: Baseline, Week 48
ACRn in Retreated Subjects at Week 48
Time frame: Baseline, Week 48
Change From Baseline in SF-36 Health Summary Scores at Week 48 in Retreated Subjects
Time frame: Baseline, Week 48
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) at Week 48 in Retreated Subjects
Time frame: Baseline, Week 48
Percentage of Retreated Subjects Achieving DAS28-ESR Remission at Week 48
Time frame: Week 48
Percentage of Retreated Subjects Achieving DAS28-ESR Low Disease at Week 48
Time frame: Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Anshu Vashishtha, MD PhD study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rituximab, methotrexate and folate in people with Rheumatoid Arthritis, run by Genentech, Inc..
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 12 inclusion and 30 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 25 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 25 May 2009). 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?
Retreated Subjects With an American College of Rheumatology 20% (ACR20) Response at Week 48 Relative to Baseline (time frame: 48 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2013.