NCT01533714

The Long-term Safety and Efficacy of CDP6038 (Olokizumab) With Active Rheumatoid Arthritis

Multi-center, Open-label, Follow-up Study to Assess the Long-term Safety and Efficacy of CDP6038 (Olokizumab) Administered Subcutaneously to Asian Subjects With Active Rheumatoid Arthritis Who Completed Study RA0083

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: UCB BIOSCIENCES, Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety and tolerability of CDP6038 (olokizumab) treatment in adult subjects with active rheumatoid arthritis (RA) who completed study RA0083 \[NCT01463059\].

Detailed description

Male and female subjects were randomized in a multi-center, open-label, follow-up study to assess the long-term safety and efficacy of a subcutaneous dose of 120 mg CDP6038 (olokizumab), every 2 weeks (q2w), for the treatment of active RA.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	CDP6038 (olokizumab)	Biological/Vaccine: CDP6038 (olokizumab) 100 mg/mL solution for subcutaneous (sc) injection

Timeline

• Start date: 2012-01-26
• Primary completion: 2013-11-27
• Completion: 2013-11-29
• First posted: 2012-02-15
• Last updated: 2022-05-20
• Results posted: 2022-05-17

Locations

32 sites across 3 countries: Japan, South Korea, Taiwan