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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02552212
Date of registration: 15/09/2015
Prospective Registration: Yes
Primary sponsor: UCB BIOSCIENCES GmbH
Public title: Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS C-AXSPAND
Scientific 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
Date of first enrolment: September 2015
Target sample size: 317
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02552212
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
Australia Bulgaria Canada Czech Republic Czechia Hungary Poland Russian Federation
Taiwan United States
Contacts
Name:     UCB Cares
Address: 
Telephone:
Email:
Affiliation:  1-844-599-2273 (UCB)
Key inclusion & exclusion criteria

Inclusion Criteria:

- At least 18 years old at the start of Screening Visit

- A documented diagnosis of adult-onset axial SpondyloArthritis (axSpA) and meet the
Assessment of SpondyloArthritis International Society (ASAS) criteria for axSpA

- Subjects must have had back pain for at least 12 months before Screening

- No sacroiliitis defined by Modified New York (mNY) criteria on sacroiliac (SI) x-rays

- Active disease at Screening as defined by

- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4

- Spinal pain >= 4 on a 0 to 10 Numerical Rating Scale (NRS)

- Inadequate response to, have a contraindication to, or have been intolerant to at
least 2 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

Exclusion Criteria:

- Diagnosis of AS or any other Inflammatory Arthritis

- Prior treatment with any experimental biological agents for treatment of Axial
SpondyloArthritis (SpA)

- Exposure to more than 1 tumor necrosis factor (TNF)-antagonist or primary failure to
TNF antagonist therapy

- History of or current chronic or recurrent infections

- Subjects with known Tuberculosis (TB) infection, at high risk of acquiring TB
infection, or latent Tuberculosis (LTB)

- 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

- Female subjects who are breastfeeding, pregnant or plan to become pregnant during the
study or within 3 months following the last dose of the investigational product

- Subjects with any other condition which, in the investigator's judgment, would make
the subject unsuitable for inclusion in the study



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Axial Spondyloarthritis
Nonradiographic Axial Spondyloarthritis
Nr-axSpA
Intervention(s)
Biological: Certolizumab Pegol
Other: Placebo
Primary Outcome(s)
Certolizumab Pegol Plasma Concentration at Baseline [Time Frame: Baseline (Week 0)]
Certolizumab Pegol Plasma Concentration at Follow-Up (FU) Visit [Time Frame: Follow-up Visit (up to Week 60)]
Certolizumab Pegol Plasma Concentration at Week 1 [Time Frame: Week 1]
Certolizumab Pegol Plasma Concentration at Week 12 [Time Frame: Week 12]
Certolizumab Pegol Plasma Concentration at Week 2 [Time Frame: Week 2]
Certolizumab Pegol Plasma Concentration at Week 24 [Time Frame: Week 24]
Certolizumab Pegol Plasma Concentration at Week 36 [Time Frame: Week 36]
Certolizumab Pegol Plasma Concentration at Week 4 [Time Frame: Week 4]
Certolizumab Pegol Plasma Concentration at Week 52 [Time Frame: Week 52]
Percentage of Subjects With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) Response Criteria Response at Week 52 [Time Frame: Week 52]
Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 12 [Time Frame: Week 12]
Secondary Outcome(s)
Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 52 [Time Frame: From Baseline to Week 52]
Change From Baseline in ASQoL at Week 1 [Time Frame: From Baseline to Week 1]
Change From Baseline in ASQoL at Week 12 [Time Frame: From Baseline to Week 12]
Change From Baseline in ASQoL at Week 2 [Time Frame: From Baseline to Week 2]
Change From Baseline in ASQoL at Week 24 [Time Frame: From Baseline to Week 24]
Change From Baseline in ASQoL at Week 36 [Time Frame: From Baseline to Week 36]
Change From Baseline in ASQoL at Week 4 [Time Frame: From Baseline to Week 4]
Change From Baseline in ASQoL at Week 48 [Time Frame: From Baseline to Week 48]
Change From Baseline in Nocturnal Spinal Pain Numerical Rating Scale (NRS) at Week 52 [Time Frame: From Baseline to Week 52]
Change From Baseline to Week 12 in Sacroiliac Spondyloarthritis Research Consortium of Canada (SI-SPARCC) Score [Time Frame: From Baseline to Week 12]
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [Time Frame: From Baseline to Week 12]
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI) [Time Frame: From Baseline to Week 12]
Change From Baseline to Week 52 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [Time Frame: From Baseline to Week 52]
Change From Baseline to Week 52 in the Bath Ankylosing Spondylitis Functional Index (BASFI) [Time Frame: From Baseline to Week 52]
Number of Subjects With Anterior Uveitis (AU) or New AU Flares Through Week 52 [Time Frame: Throughout the study conduct (up to Week 52)]
Number of Subjects Without Relevant Changes to Background Medication From Baseline to Week 52 [Time Frame: From Baseline to Week 52]
Percentage of Subjects With Adverse Events Leading to Withdrawal From Investigational Medicinal Product (IMP) During the Study [Time Frame: From Baseline until Week 52]
Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 52 [Time Frame: Week 52]
Percentage of Subjects With Serious Adverse Events (SAEs) During the Study [Time Frame: From Baseline until Week 52]
Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) During the Study [Time Frame: From Baseline until Week 52]
Secondary ID(s)
2015-001894-41
AS0006
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 17/08/2020
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02552212
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