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MabThera/Rituxan · 1 trial · 1 indication
American College of Rheumatology (ACR) 20 response is defined as \>= 20% improvement (reduction) in score compared with baseline for both tender joint count (TJC)-68 joints and swollen joint count (SJC)-66 joints, as well as for 3 of the additional 5 ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) ranging from score 0 (no pain) to 100 (unbearable pain); Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS ranging score 0 (no disease activity) to 100 (maximum disease activity); Health Assessment Questionnaire (HAQ):8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale (0=without any difficulty to 3=unable to do) for a total possible score of 0 (best) to 3 (worst); and acute-phase reactant, either C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR).
| Arm | Type | Description |
|---|---|---|
| Placebo Plus Methotrexate | PLACEBO_COMPARATOR | Participants will be administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg per os (p.o.) or parenterally once a week up to 24 weeks and will be followed up to Week 104. |
| Rituximab plus Methotrexate | EXPERIMENTAL | Participants will be administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and will be followed up to Week 104. |
| Name | Type | Description |
|---|---|---|
| MabThera/Rituxan | DRUG | 1 |
| Methotrexate | DRUG | 2 |
| Placebo | OTHER | 3 |
Inclusion Criteria: * Adult participants 18-80 years of age with active RA for at least 6 months; * Received treatment for RA on an outpatient basis and experienced an inadequate response or intolerance to treatment with at least 1 anti-TNF alpha therapy (etanercept, infliximab or adalimumab); * Mu...
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MabThera/Rituxan is used for the treatment of active Rheumatoid Arthritis in combination with methotrexate (MTX) in patients who have failed on anti-tumor necrosis factor alpha therapy. It is being investigated as a Phase 3 therapy for this indication.
MabThera/Rituxan is being developed by Biogen Inc., which is publicly traded under the ticker symbol BIIB. The drug is being studied for the treatment of Rheumatoid Arthritis.
MabThera/Rituxan is in Phase 3 clinical development for Rheumatoid Arthritis. It is an investigational therapy and has not been approved for this indication based on the available data.
MabThera/Rituxan has one completed Phase 3 clinical trial, NCT00468546, which evaluated its safety and efficacy in combination with methotrexate in participants with active Rheumatoid Arthritis who failed on anti-TNF alpha therapy. The trial enrolled 520 participants.
Yes, MabThera and Rituxan are alternative names for the same drug. The drug is being developed by Biogen Inc. for the treatment of Rheumatoid Arthritis.