Trials / Completed
CompletedNCT01087762
Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis
Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 325 (actual)
- Sponsor
- UCB BIOSCIENCES GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of two dose regimens of Certolizumab Pegol (CZP) in subjects with active axial Spondyloarthritis (axial SpA).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CZP 200 mg Q2W | 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W). |
| BIOLOGICAL | CZP 400 mg Q4W | 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W). |
| OTHER | Placebo | Matching Placebo to CZP injection. |
Timeline
- Start date
- 2010-03-01
- Primary completion
- 2011-10-01
- Completion
- 2015-08-01
- First posted
- 2010-03-16
- Last updated
- 2018-08-01
- Results posted
- 2013-12-25
Locations
104 sites across 15 countries: United States, Argentina, Belgium, Brazil, Canada, Czechia, France, Germany, Hungary, Italy, Mexico, Netherlands, Poland, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01087762. Inclusion in this directory is not an endorsement.