Rheumatoid Arthritis Clinical Trial
Official title:
A Randomized, Placebo Controlled, Multicenter Clinical Study Investigating Efficacy of Rituximab in the Inhibition of Joint Structural Damage Assessed by Magnetic Resonance Imaging in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate
This 3 arm study assessed the efficacy of rituximab (MabThera®/Rituxan®) in the prevention of progression of structural joint damage in participants with active rheumatoid arthritis who had an inadequate clinical response to methotrexate. Participants were randomized to receive rituximab 500 mg intravenously (iv), rituximab 1000 mg iv, or placebo iv on days 1 and 15 every 24 weeks in the main study; all participants received concomitant methotrexate at a stable dose of 12.5-25 mg/week throughout the study. Further courses of rituximab were provided to eligible participants. Structural joint damage was assessed by magnetic resonance imaging (MRI) at baseline and at intervals during the study.
There were 3 phases in the study: A 52 week long main study, a study extension phase, and a
48 week long safety follow-up phase.
The first course of treatment with placebo or rituximab was initiated on Day 1 of the 52
week long main study. A second course of treatment was initiated after Week 24, if the
participant met eligibility criteria. After Week 52, eligible participants received further
treatment courses at intervals ≥ 6 months in the study extension phase. No treatments were
administered in the safety follow-up phase.
Participants had to meet the following eligibility criteria to receive rituximab in the
study extension phase.
- Minimum of 24 weeks had passed since the first infusion of the last course of study
medication.
- C-reactive protein-based Disease Activity Score 28 (DAS28-CRP) ≥ 2.6.
- Absolute neutrophil count not below 1.5 x 103/μL.
- Patient had not developed contraindications for receiving rituximab, such as:
1. Any new or uncontrolled concomitant disease such as, but not limited to,
cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or
gastrointestinal disorders.
2. Primary or secondary immunodeficiency (history of, or currently active), including
known history of HIV infection.
3. Known active infection of any kind (excluding fungal infections of nail beds), or
any major episode of infection requiring hospitalization, or treatment with iv
anti-infectives within 4 weeks prior to infusion or completion of oral
anti-infectives within 2 weeks prior to infusion.
- Patient was not pregnant or breast feeding.
- Patients who entered the study and were found to be hepatitis B surface antigen (HBsAg)
negative, hepatitis B core antibody (HBcAb) positive, were to be negative for hepatitis
B viral DNA (< 29 IU/mL) and were to have aspartate aminotransferase (AST)/alanine
aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) results within the last 12
weeks.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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