Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS (C-AXSPAND)
Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS (C-AXSPAND)
ClinicalTrials.gov ID: NCT02552212
Sponsor: UCB BIOSCIENCES GmbH
Information provided by: UCB Pharma (UCB BIOSCIENCES GmbH) (Responsible Party)
Last Update Posted: 2022-08-18
Brief Summary:
Patients with active Axial Spondyloarthritis without x-ray evidence of Ankylosing Spondylitis and with signs of inflammation will be randomly assigned to receive certolizumab pegol (CZP) 200 mg every two weeks or placebo. The primary objective is to demonstrate the efficacy of CZP in these patients.
Official Title:
Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis (axSpA) Without X-Ray Evidence of Ankylosing Spondylitis (AS) and Objective Signs of Inflammation
Intervention / Treatment:
- Biological: Certolizumab Pegol
- Other: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2015-09 |
| Primary Completion (Estimated) | 2018-05 |
| Study Completion (Estimated) | 2020-05 |
| Enrollment (Estimated) | 317 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
AS0006
2015-001894-41 (EudraCT Number) |