Trial intelligence / Profile preview

RAPID-axSpA

NCT01087762Phase 3

Key facts

Status: Completed
Start: Mar 2010
Primary completion: Oct 2011
Countries: 15
Sponsor: UCB
Modality: Antibody Fragments, Polymer-based Nanoparticles

Drugs: certolizumab pegol
Conditions: axial spondyloarthritis (axSpA)

Overview

Phase 3, randomised, double-blind trial of certolizumab pegol in axial spondyloarthritis (axSpA) (3 arms), sponsored by UCB. Primary endpoint: Assessment in Axial Spondyloarthritis International Society 20% Response Criteria at 12 weeks. Started Mar 2010; status: completed.

Design

3 arms

Study design: RandomizedDouble-blind

CZP 200 mg Q2W
Certolizumab Pegol 200 mg Q2W (following 400 mg loading doses)
CZP 400 mg Q4W
Certolizumab Pegol 400 mg Q4W (following 400 mg loading doses)
Placebo
Placebo matching CZP, switching to CZP at Week 16 (escape) or Week 24

Who it enrols

Adult patients with documented diagnosis of active axial Spondyloarthritis (axSpA) of at least 3 months' duration, defined by ASAS criteria, with active disease (BASDAI >= 4, spinal pain >= 4, elevated CRP or MRI sacroiliitis) and intolerance or inadequate response to at least 1 NSAID.

Endpoints

Primary

Assessment in Axial Spondyloarthritis International Society 20% Response Criteria12 weeks

Secondary

Assessment in Axial Spondyloarthritis International Society 20% Response Criteria24 weeks
Bath Ankylosing Spondylitis Functional Index24 weeks
Bath Ankylosing Spondylitis Disease Activity Index24 weeks
Bath Ankylosing Spondylitis Metrology Index24 weeks
Ankylosing Spondylitis Spine Magnetic Resonance Imaging Scoring System for Disease Activity12 weeks
Sacroiliac Spondyloarthritis Research Consortium of Canada Score12 weeks

Results

Primary endpoints met

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