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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:  NCT02505542
Date of registration: 16/07/2015
Prospective Registration: Yes
Primary sponsor: UCB BIOSCIENCES GmbH
Public title: Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo C-OPTIMISE
Scientific title: A Multicenter, Open-label (Part A) Followed by a Randomized, Double-blind, Parallel-group, Placebo Controlled Study (Part B) to Evaluate Maintenance of Remission in Subjects With Active Axial Spondyloarthritis (axSpA) Receiving Either Certolizumab Pegol 200 mg Q2W or 200 mg Q4W as Compared to Placebo
Date of first enrolment: July 2015
Target sample size: 736
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02505542
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 3
Countries of recruitment
Belgium Bulgaria Czech Republic Czechia France Germany Hungary Netherlands
Poland Romania Spain Taiwan Turkey United Kingdom United States
Contacts
Name:     UCB Cares
Address: 
Telephone:
Email:
Affiliation:  +1 844 599 2273(UCB)
Key inclusion & exclusion criteria

Inclusion Criteria:

- Documented diagnosis of adult-onset axial SpondyloArthritis (axSpA) with at least 3
months' symptom duration and meet the Assessment of SpondyloArthritis International
Society (ASAS) criteria for axSpA and symptom duration of less than 5 years prior to
the participation of this study

- Active disease at Screening as defined by

- Ankylosing Spondylitis Disease Activity Score (ASDAS) = 2.1

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

- Spinal pain > 4 on a 0 to 10 Numerical Rating Scale (NRS) (from BASDAI Item 2)

- for modified New York (mNY) -negative subjects only: C-reactive Protein (CRP) >
upper limit of normal (ULN) and/or current evidence for sacroiliitis on the
Screening Magnetic Resonance Imaging (MRI)

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

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 primary failure to TNF antagonist therapy

- 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

- 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: 45 Years
Gender: All
Health Condition(s) or Problem(s) studied
Ankylosing Spondylitis
Axial Spondyloarthrithis
Intervention(s)
Biological: Certolizumab Pegol
Other: Placebo
Primary Outcome(s)
Percentage of Participants in Part B Who Did Not Experienced a Flare [Time Frame: From Week 48 to Week 96]
Secondary Outcome(s)
Certolizumab Pegol (CZP) Plasma Concentration During the Study [Time Frame: From Week 0 until the Safety Follow-up Visit (10 weeks after the last dose of study medication)]
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Escape Week 12 for Participants Who Experienced a Flare in Part B [Time Frame: From time of flare to Escape Week 12]
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 96 in Part B [Time Frame: From Week 48 to Week 96]
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Escape Week 12 for Participants Who Experienced a Flare in Part B [Time Frame: From time of flare to Escape Week 12]
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 96 in Part B [Time Frame: From Week 48 to Week 96]
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Escape Week 12 for Participants Who Experienced a Flare in Part B [Time Frame: From time of flare to Escape Week 12]
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 96 in Part B [Time Frame: From Week 48 to Week 96]
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Escape Week 12 for Participants Who Experienced a Flare in Part B [Time Frame: From time of flare to Escape Week 12]
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 96 in Part B [Time Frame: From Week 48 to Week 96]
Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Escape Week 12 for Participants Who Experienced a Flare in Part B [Time Frame: From time of flare to Escape Week 12]
Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 96 in Part B [Time Frame: From Week 48 to Week 96]
Change From Baseline in Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging Score for Activity (ASspIMRI-a) in the Berlin Modification Score at Escape Week 12 for Participants Who Experienced a Flare in Part B [Time Frame: From time of flare to Escape Week 12]
Change From Baseline in Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging Score for Disease Activity (ASspIMRI-a) in the Berlin Modification Score at Week 96 in Part B [Time Frame: From Week 48 to Week 96]
Percentage of Participants Achieving Sustained Remission at Week 48 in Part A [Time Frame: Week 48]
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Escape Week 12 for Participants Who Experienced a Flare in Part B [Time Frame: Escape Week 12]
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Week 48 in Part A [Time Frame: Week 48]
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Week 96 in Part B [Time Frame: Week 96]
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Escape Week 12 for Participants Who Experienced a Flare in Part B [Time Frame: Escape Week 12]
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 48 in Part A [Time Frame: Week 48]
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 96 in Part B [Time Frame: Week 96]
Percentage of Participants With at Least One Adverse Event (AE) and Who Experienced a Flare During Part B of the Study [Time Frame: From time of flare to Escape Week 12]
Percentage of Participants With at Least One Adverse Event (AE) During Part A of the Study [Time Frame: From Screening Period (Week -5 to Week -1) until Week 48]
Percentage of Participants With at Least One Adverse Event (AE) During Part B of the Study [Time Frame: From Week 0 until the Safety Follow-up Visit (10 weeks after the last dose of study medication)]
Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) 5/6 Response Criteria Response at Escape Week 12 for Participants Who Experienced a Flare in Part B [Time Frame: Escape Week 12]
Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) 5/6 Response Criteria Response at Week 96 in Part B [Time Frame: Week 96]
Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response Criteria Response at Escape Week 12 for Participants Who Experienced a Flare in Part B [Time Frame: Escape Week 12]
Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response Criteria Response at Week 96 in Part B [Time Frame: Week 96]
Percentage of Participants With Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at Escape Week 12 for Participants Who Experienced a Flare in Part B [Time Frame: Escape Week 12]
Percentage of Participants With Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at Week 96 in Part B [Time Frame: Week 96]
Percentage of Participants With Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at Escape Week 12 for Participants Who Experienced a Flare in Part B [Time Frame: Escape Week 12]
Percentage of Participants With Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at Week 96 in Part B [Time Frame: Week 96]
Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response Criteria Response at Week 96 in Part B [Time Frame: Week 96]
Percentage of Participants With Positive Anti-certolizumab Pegol-antibody Levels in Plasma During the Study [Time Frame: From Week 0 until the Safety Follow-up Visit (10 weeks after the last dose of study medication)]
Time to Flare in Part B [Time Frame: From Week 48 to Week 96]
Secondary ID(s)
2015-000339-34
AS0005
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Parexel
Ethics review
Results
Results available: Yes
Date Posted: 21/04/2020
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02505542
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