NCT02640612

Long-term Assessment of Safety and Efficacy of BI 695501 in Patients With Rheumatoid Arthritis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 430 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	BI 695501

Timeline

• Start date: 2016-01-22
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2015-12-29
• Last updated: 2018-12-05
• Results posted: 2018-12-05

Locations

91 sites across 14 countries: United States, Bulgaria, Chile, Estonia, Germany, Hungary, Malaysia, Poland, Russia, Serbia, South Korea, Spain, Thailand, Ukraine