Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.
- Conditions
- rheumarheumatoid arthritis1000381610007951
- Registration Number
- NL-OMON41649
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
Adult patients, between 18 and 80 years of age, with moderately to severely active RA for at least 6 months as defined by at least six swollen joints (66 joint count) and at least eight tender joints (68 joint count) at Screening and Baseline (Day 1), and either an erythrocyte sedimentation rate (ESR) of > 28 mm/hour OR a C-reactive protein (CRP) level > 1.0 mg/dL (normal: < 0.4 mg/dL) at Screening. Patients must have had an inadequate response or intolerance to conventional disease modifying anti-rheumatic drug (DMARD) therapy including at least one tumor necrosis factor (TNF) inhibitor.
Must be currently receiving and tolerating oral or parenteral therapy at a dose of 15-25 mg per week (dose may be as low as 10 mg per week if the patient is unable to tolerate a higher dose) for at least 12 weeks immediately prior to Day 1. The dose should be stable for at least 4 weeks prior to Day 1 (for all inclusion criteria see also page 35-36 of the protocol).
Patients with active infection, severe immunosuppression or severe heart failure will be excluded (for all exclusion criteria see page 36-38 of the protocol).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>PK (Part I only): AUC0-tz, AUC0-*. pred (determined after the second drug<br /><br>infusion)<br /><br>Efficacy co-primary endpoints: Change in DAS28 (ESR) from Baseline to Week 24.</p><br>
- Secondary Outcome Measures
Name Time Method