Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis

UCB BIOSCIENCES GmbH104 sites in 5 countries325 target enrollmentMarch 2010

ConditionsSpondyloarthropathies

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Spondyloarthropathies
Sponsor: UCB BIOSCIENCES GmbH
Enrollment: 325
Locations: 104
Primary Endpoint: Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 12
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

March 2010

End Date

August 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

UCB BIOSCIENCES GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Documented diagnosis of adult-onset axial Spondyloarthritis (SpA) of at least 3 months' duration as defined by the specified Assessment of Spondyloarthritis International Society (ASAS) criteria
•Active disease as defined by:
•Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4
•Back pain ≥ 4 on a 0 to 10 Neurobehavioral Rating Scale (NRS) (from BASDAI item 2)
•C-Reactive Protein (CRP) \> ULN (Upper Limit of Normal) and/or current evidence (ie, within the last 3 months from Screening) for Sacroiliitis on Magnetic Resonance Imaging (MRI) as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria
•Intolerance to or inadequate response to at least 1 Nonsteroidal Anti-Inflammatory Drug (NSAID)

Exclusion Criteria

•Presence of total Spinal Ankylosis ("bamboo spine")
•Diagnosis of any other Inflammatory Arthritis
•Prior treatment with any experimental biological agents for treatment of Axial Spondyloarthritis (SpA)
•Exposure to more than 1 TNF-antagonist or to more than 2 previous biological agents for Axial Spondyloarthritis (SpA)
•History of or current chronic or recurrent infections
•High risk of infection
•Recent live vaccination
•Concurrent malignancy or a history of malignancy
•Class III or IV congestive heart failure - New York Heart Association (NYHA)
•Demyelinating disease of the central nervous system

Outcomes

Primary Outcomes

Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 12

Time Frame: Week 12

The ASAS20 is defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains: * Patient's Global Assessment of Disease Activity * Pain assessment (total spinal pain) * Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) * Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain (deterioration is defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit).

Secondary Outcomes

Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12(From Baseline to Week 12)
Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 12(From Baseline to Week 12)
Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 24(Week 24)
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24(From Baseline to Week 24)
Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24(From Baseline to Week 24)
Change From Baseline in the Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging (MRI) Scoring System for Disease Activity (ASspiMRI-a) in the Berlin Modification at Week 12(From Baseline to Week 12)
Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12(From Baseline to Week 12)
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12(From Baseline to Week 12)
Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 24(From Baseline to Week 24)