Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo (C-OPTIMISE)
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ClinicalTrials.gov Identifier: NCT02505542 |
Recruitment Status :
Completed
First Posted : July 22, 2015
Results First Posted : April 21, 2020
Last Update Posted : December 17, 2020
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Sponsor:
UCB BIOSCIENCES GmbH
Collaborator:
Parexel
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Conditions |
Axial Spondyloarthrithis Ankylosing Spondylitis |
Interventions |
Biological: Certolizumab Pegol Other: Placebo |
Enrollment | 736 |
Participant Flow
Recruitment Details | The study started to enroll patients in July 2015 and concluded in April 2019. |
Pre-assignment Details |
The study included 2 parts: Part A with a Screening Period (up to 5 Weeks) and an Open-Label Period (Week 0 to Week 48) and Part B with a Double-Blind Period (Week 48 to Week 96) and a Safety Follow-Up Period (10 weeks after the last dose of study medication). Participant Flow refers to the Open-Label Set. |
Arm/Group Title | Certolizumab Pegol Open-Label | Placebo Double-Blind | Certolizumab Pegol 200 mg Q2W Double-Blind | Certolizumab Pegol 200 mg Q4W Double-Blind |
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Participants in this arm received certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 to Week 48 (Part A). Participants in sustained remission at Week 48 were eligible for randomization into Part B. | Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. | Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. | Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. |
Period Title: Part A: Open-Label Period | ||||
Started | 736 | 0 | 0 | 0 |
Completed | 659 | 0 | 0 | 0 |
Not Completed | 77 | 0 | 0 | 0 |
Reason Not Completed | ||||
Adverse Event | 31 | 0 | 0 | 0 |
Lack of Efficacy | 5 | 0 | 0 | 0 |
Protocol Violation | 1 | 0 | 0 | 0 |
Lost to Follow-up | 5 | 0 | 0 | 0 |
Withdrawal by Subject | 27 | 0 | 0 | 0 |
New medical history available | 1 | 0 | 0 | 0 |
Participant did not attend week 48 visit | 1 | 0 | 0 | 0 |
Pregnancy | 2 | 0 | 0 | 0 |
Sponsor directive | 1 | 0 | 0 | 0 |
Medical monitor decision | 1 | 0 | 0 | 0 |
Screening failure (detected too late) | 1 | 0 | 0 | 0 |
Non-compliance | 1 | 0 | 0 | 0 |
Period Title: Completed Part A, Did Not Enter Part B | ||||
Started | 659 | 0 | 0 | 0 |
Completed | 313 | 0 | 0 | 0 |
Not Completed | 346 | 0 | 0 | 0 |
Reason Not Completed | ||||
Lack of Efficacy | 2 | 0 | 0 | 0 |
Withdrawal by Subject | 3 | 0 | 0 | 0 |
The subject was not eligible for Part B | 341 | 0 | 0 | 0 |
Period Title: Part B: Double-Blind Period | ||||
Started | 0 | 104 | 104 | 105 |
Started Escape Period | 0 | 73 | 7 | 15 |
Completed | 0 | 92 | 95 | 98 |
Not Completed | 0 | 12 | 9 | 7 |
Reason Not Completed | ||||
Adverse Event | 0 | 0 | 1 | 3 |
Lost to Follow-up | 0 | 0 | 0 | 1 |
Withdrawal by Subject | 0 | 8 | 7 | 2 |
Planning pregnancy | 0 | 1 | 0 | 0 |
Week 94 missed | 0 | 0 | 1 | 0 |
Patient was moved from the country | 0 | 0 | 0 | 1 |
Lack of Efficacy | 0 | 1 | 0 | 0 |
Miscalculation | 0 | 1 | 0 | 0 |
Subject did not complete all visits | 0 | 1 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Certolizumab Pegol Open-Label | |
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Participants in this arm received certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 to Week 48 (Part A). Participants in sustained remission at Week 48 were eligible for randomization into Part B. | |
Overall Number of Baseline Participants | 736 | |
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Baseline Characteristics refer to the The Open-Label Set (OLS) which consisted of all study participants who received at least 1 dose of investigational medicinal product (IMP) in the Open-Label Period of the study (Part A).
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 736 participants | |
<=18 years |
7 1.0%
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Between 18 and 65 years |
729 99.0%
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>=65 years |
0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 736 participants | |
32.9 (7.0) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 736 participants | |
Female |
222 30.2%
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Male |
514 69.8%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 736 participants | |
American indian/alaskan native |
2 0.3%
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Asian |
38 5.2%
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Black |
1 0.1%
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White |
681 92.5%
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Other/Mixed |
5 0.7%
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Missing |
9 1.2%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | UCB |
Organization: | Cares |
Phone: | +1844 599 ext 2273 |
EMail: | UCBCares@ucb.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | UCB Pharma ( UCB BIOSCIENCES GmbH ) |
ClinicalTrials.gov Identifier: | NCT02505542 |
Other Study ID Numbers: |
AS0005 2015-000339-34 ( EudraCT Number ) |
First Submitted: | July 16, 2015 |
First Posted: | July 22, 2015 |
Results First Submitted: | February 26, 2020 |
Results First Posted: | April 21, 2020 |
Last Update Posted: | December 17, 2020 |