Rheumatoid ArthritisPhase 2NCT00074438
Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis
A Phase 2 study testing methotrexate, rituximab and corticosteroids in people with Rheumatoid Arthritis, run by Genentech, Inc..
Trial summary
This study will assess the efficacy and safety of different treatment regimens of rituximab (MabThera®/Rituxan®), corticosteroids, and placebo, combined with methotrexate (MTX), in patients with active rheumatoid arthritis (RA). 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?
- methotrexate, rituximab and corticosteroids
- 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
- 465 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to Jul 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
Eligibility criteria include, but are not limited to the following:
- Are between the ages of 18 and 80 years.
- Have been diagnosed with rheumatoid arthritis for at least 6 months.
- Have failed treatment (lack of efficacy) with at least 1 but no more than 5 disease-modifying anti-rheumatic drugs or biologics (other than methotrexate).
About this study
Official title: Randomized, Multifactorial, Double-blind, Parallel-group, Dose-ranging Study of the Efficacy and Safety of Rituximab (MabThera®/Rituxan®) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
This study will assess the efficacy and safety of different treatment regimens of rituximab (MabThera®/Rituxan®), corticosteroids, and placebo, combined with methotrexate (MTX), in patients with active rheumatoid arthritis (RA).
- Conditions
- Rheumatoid Arthritis
- Being tested
- methotrexate, rituximab, corticosteroids, placebo
- Keywords
- Rituxan, RA
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methotrexateDrug
Oral or parenteral repeating dose
rituximabDrug
Intravenous repeating dose
corticosteroidsDrug
Intravenous repeating dose
placeboDrug
Intravenous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: methotrexate; Drug: rituximab |
| 2 | Experimental | Not described Receives: Drug: methotrexate; Drug: rituximab; Drug: corticosteroids |
| 3 | Experimental | Not described Receives: Drug: methotrexate; Drug: rituximab; Drug: corticosteroids |
| 4 | Experimental | Not described Receives: Drug: methotrexate; Drug: rituximab |
| 5 | Experimental | Not described Receives: Drug: methotrexate; Drug: rituximab; Drug: corticosteroids |
| 6 | Experimental | Not described Receives: Drug: methotrexate; Drug: rituximab; Drug: corticosteroids |
| 7 | Placebo comparator | Not described Receives: Drug: methotrexate; Drug: placebo |
| 8 | Placebo comparator | Not described Receives: Drug: methotrexate; Drug: corticosteroids; Drug: placebo |
| 9 | Placebo comparator | Not described Receives: Drug: methotrexate; Drug: corticosteroids; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with an ACR20 response
Measured: 24 weeks
Secondary outcomes (2)
Proportion of patients with ACR(50,70) responses
Measured: 24 weeks
Proportion of patients with an ACR20 response in the medium- and high-dose corticosteroid groups
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2003 (estimated)
- Study startJun 2003
- Primary completionSep 2004
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00074438
- Sponsor's protocol ID
- WA17043/U2644g
- Other IDs
- WA17043
- Status last verified
- May 2013
- First submitted
- 12 Dec 2003
- Last updated
- 9 May 2013
- Results posted
- No
Publications
Keystone E, Fleischmann R, Emery P, Furst DE, van Vollenhoven R, Bathon J, Dougados M, Baldassare A, Ferraccioli G, Chubick A, Udell J, Cravets MW, Agarwal S, Cooper S, Magrini F. Safety and efficacy of additional courses of rituximab in patients with active rheumatoid arthritis: an open-label extension analysis. Arthritis Rheum. 2007 Dec;56(12):3896-908. doi: 10.1002/art.23059.
PubMed 18050221
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multifactorial, Double-blind, Parallel-group, Dose-ranging Study of the Efficacy and Safety of Rituximab (MabThera®/Rituxan®) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00074438
- Acronym / sponsor ID
- WA17043/U2644g
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rituxan, RA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Roche Pharma AG
- Study start
- Jun 2003
- Primary completion
- Sep 2004 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 15 Dec 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the efficacy and safety of different treatment regimens of rituximab (MabThera®/Rituxan®), corticosteroids, and placebo, combined with methotrexate (MTX), in patients with active rheumatoid arthritis (RA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: methotrexate, Drug: rituximab |
| 2 | Experimental | Drug: methotrexate, Drug: rituximab, Drug: corticosteroids |
| 3 | Experimental | Drug: methotrexate, Drug: rituximab, Drug: corticosteroids |
| 4 | Experimental | Drug: methotrexate, Drug: rituximab |
| 5 | Experimental | Drug: methotrexate, Drug: rituximab, Drug: corticosteroids |
| 6 | Experimental | Drug: methotrexate, Drug: rituximab, Drug: corticosteroids |
| 7 | Placebo comparator | Drug: methotrexate, Drug: placebo |
| 8 | Placebo comparator | Drug: methotrexate, Drug: corticosteroids, Drug: placebo |
| 9 | Placebo comparator | Drug: methotrexate, Drug: corticosteroids, Drug: placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| methotrexateOral or parenteral repeating dose | Drug | 1, 2, 3, 4, 5, 6, 7, 8, 9 |
| rituximabIntravenous repeating dose | Drug | 1, 2, 3, 4, 5, 6 |
| corticosteroidsIntravenous repeating dose | Drug | 2, 3, 5, 6, 8, 9 |
| placeboIntravenous repeating dose | Drug | 7, 8, 9 |
Primary outcome
Proportion of patients with an ACR20 response
Time frame: 24 weeks
2 secondary outcomes
Proportion of patients with ACR(50,70) responses
Time frame: 24 weeks
Proportion of patients with an ACR20 response in the medium- and high-dose corticosteroid groups
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2013.
- Derived from this study: PubMed 18050221Keystone E, Fleischmann R, Emery P, Furst DE, van Vollenhoven R, Bathon J, Dougados M, Baldassare A, Ferraccioli G, Chubick A, Udell J, Cravets MW, Agarwal S, Cooper S, Magrini F. Safety and efficacy of additional courses of rituximab in patients with active rheumatoid arthritis: an open-label extension analysis. Arthritis Rheum. 2007 Dec;56(12):3896-908. doi: 10.1002/art.23059.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing methotrexate, rituximab and corticosteroids 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?
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 9 May 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients with an ACR20 response (time frame: 24 weeks). 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 NCT00074438, 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 9 May 2013.