Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: methotrexate
* Drug: rituximab
* Drug: corticosteroids
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: methotrexate<br>* Oral or parenteral repeating dose<br>Drug: rituximab<br>* Intravenous repeating dose<br>|
| Experimental: 2<br> | Drug: methotrexate<br>* Oral or parenteral repeating dose<br>Drug: rituximab<br>* Intravenous repeating dose<br>Drug: corticosteroids<br>* Intravenous repeating dose<br>|
| Experimental: 3<br> | Drug: methotrexate<br>* Oral or parenteral repeating dose<br>Drug: rituximab<br>* Intravenous repeating dose<br>Drug: corticosteroids<br>* Intravenous repeating dose<br>|
| Experimental: 4<br> | Drug: methotrexate<br>* Oral or parenteral repeating dose<br>Drug: rituximab<br>* Intravenous repeating dose<br>|
| Experimental: 5<br> | Drug: methotrexate<br>* Oral or parenteral repeating dose<br>Drug: rituximab<br>* Intravenous repeating dose<br>Drug: corticosteroids<br>* Intravenous repeating dose<br>|
| Experimental: 6<br> | Drug: methotrexate<br>* Oral or parenteral repeating dose<br>Drug: rituximab<br>* Intravenous repeating dose<br>Drug: corticosteroids<br>* Intravenous repeating dose<br>|
| Placebo Comparator: 7<br> | Drug: methotrexate<br>* Oral or parenteral repeating dose<br>Drug: placebo<br>* Intravenous repeating dose<br>|
| Placebo Comparator: 8<br> | Drug: methotrexate<br>* Oral or parenteral repeating dose<br>Drug: corticosteroids<br>* Intravenous repeating dose<br>Drug: placebo<br>* Intravenous repeating dose<br>|
| Placebo Comparator: 9<br> | Drug: methotrexate<br>* Oral or parenteral repeating dose<br>Drug: corticosteroids<br>* Intravenous repeating dose<br>Drug: placebo<br>* Intravenous repeating dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with an ACR20 response |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with ACR(50,70) responses |  | 24 weeks | 
| Proportion of patients with an ACR20 response in the medium- and high-dose corticosteroid groups |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rituxan, RA