Arthritis, Rheumatoid Clinical Trial
Official title:
Long-term Assessment of Safety, Efficacy, Pharmacokinetics and Immunogenicity of BI 695501 in Patients With Rheumatoid Arthritis (RA): an Open-label Extension Trial for Patients Who Have Completed Trial 1297.2 and Are Eligible for Long-term Treatment With Adalimumab
The main objective of this trial is to provide long-term safety, pharmacokinetics (PK), and
immunogenicity data on BI 695501 administered via prefilled syringe in patients with
Rheumatoid Arthritis who have completed Trial 1297.2. The primary endpoint thereby is the
number (proportion) of patients with drug-related adverse events (AEs) during the treatment
phase. The secondary objective in this trial is the assessment of Long-term efficacy of BI
695501 by evaluation of:
- the change from Baseline in DAS28 (ESR) at Week 48
- the proportion of patients meeting American College of Rheumatology 20% (ACR20) response
criteria at Week 48
- the proportion of patients who meet the American College of Rheumatology (ACR)/European
League Against Rheumatism (EULAR) definition of remission at Week 48
- the proportion of patients with EULAR response (good response, moderate response, or no
response) at Week 48.
n/a
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