NCT01296711

Open-label Study to Assess the Safety and Efficacy of CDP6038 (Olokizumab) in Patients Who Completed RA0056

A Phase 2, Multicenter, Open-Label, Follow-up Study to Assess the Long-Term Safety and Efficacy of CDP6038 (Olokizumab) Administered Subcutaneously to Subjects With Active Rheumatoid Arthritis Who Completed Study RA0056

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: UCB BIOSCIENCES, Inc. · Industry
• Sex: All
• Age: 18 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 who completed study RA0056 (NCT01242488).

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 two weeks, for the treatment of active rheumatoid arthritis.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	CDP6038 (olokizumab)	100mg/ml solution for injection 120 mg subcutaneously (sc) every 2 weeks

Timeline

• Start date: 2011-03-07
• Primary completion: 2013-05-01
• Completion: 2013-08-05
• First posted: 2011-02-15
• Last updated: 2022-04-14
• Results posted: 2022-04-14

Locations

55 sites across 3 countries: United States, Belgium, United Kingdom