Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo
C-OPTIMISE
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
2 other identifiers
interventional
736
14 countries
108
Brief Summary
Patients receive study drug for one year (Part A). If, after the initial run-in phase, a sustained remission is reached they will be randomly split into one of three dose groups for another year (Part B). The maintenance of the sustained remission will be analyzed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2015
Typical duration for phase_3
108 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 16, 2015
CompletedFirst Posted
Study publicly available on registry
July 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedResults Posted
Study results publicly available
April 21, 2020
CompletedDecember 17, 2020
November 1, 2020
3.6 years
July 16, 2015
February 26, 2020
November 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants in Part B Who Did Not Experienced a Flare
A participant was considered to have experienced a flare if the participant had an Ankylosing spondylitis disease activity score (ASDAS) greater or equal to (≥) 2.1 at 2 consecutive visits or an ASDAS greater than (\>) 3.5 at any visit during Part B up until Week 96. A participant qualified for Part B only if he achieved sustained remission after 48 weeks of Open-Label certolizumab pegol (CZP) treatment. Sustained remission was achieved when a participant had an ASDAS less than (\<) 1.3 at Week 32 or Week 36 (if ASDAS \< 1.3 at Week 32, it must have been \< 2.1 at Week 36; if ASDAS \< 2.1 at Week 32, it must have been \< 1.3 at Week 36) and an ASDAS \< 1.3 at Week 48. Missing data were handled using non-response imputation (NRI) methods.
From Week 48 to Week 96
Secondary Outcomes (34)
Percentage of Participants Achieving Sustained Remission at Week 48 in Part A
Week 48
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 48 in Part A
Week 48
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Week 48 in Part A
Week 48
Time to Flare in Part B
From Week 48 to Week 96
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 96 in Part B
Week 96
- +29 more secondary outcomes
Study Arms (7)
Open-label Certolizumab Pegol
OTHERCertolizumab 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). Subjects in sustained remission at Week 48 are eligible for randomization into Part B.
Double-blind Certolizumab Pegol 200 mg Q2W
EXPERIMENTALCertolizumab Pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.
Double-blind Certolizumab Pegol 200 mg Q4W
EXPERIMENTALCertolizumab Pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP is not received, subjects receive one injection of Placebo to maintain the study blind.
Placebo
PLACEBO COMPARATOROne placebo injection is administered every 2 weeks from Week 48 onwards.
Placebo to CZP 200 mg Q2W escape
OTHERSubjects randomized to Placebo who meet flare criteria receive CZP 400 mg subcutaneous (sc) every 2 weeks (Q2W) for the first 3 visits after flare has been confirmed. After that, CZP 200 mg is given every 2 weeks in open-label fashion.
CZP 200 mg Q4W to CZP 200 mg Q2W escape
OTHERSubjects randomized to CZP 200 mg Q4W who meet flare criteria receive CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, subjects receive one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
CZP 200 mg Q2W to CZP 200 mg Q2W escape
OTHERSubjects randomized to CZP 200 mg Q2W who meet flare criteria receive CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, subjects receive one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Interventions
* Active substance: Certolizumab Pegol * Pharmaceutical form: Prefilled syringe * Concentration: 200 mg / ml * Route of Administration: Subcutaneous injection
* Active substance: Placebo * Pharmaceutical form: Prefilled syringe * Concentration: 0.9 % Saline * Route of Administration: Subcutaneous injection
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB BIOSCIENCES GmbHlead
- Parexelcollaborator
Study Sites (108)
As0005 2313
Glendale, Arizona, 85304, United States
As0005 2316
Mesa, Arizona, 85202, United States
As0005 2314
Phoenix, Arizona, 85037, United States
As0005 2317
Sun City, Arizona, 85351, United States
As0005 2307
Palm Desert, California, 92260, United States
As0005 2310
San Francisco, California, 94143, United States
As0005 2305
Upland, California, 91786, United States
As0005 2308
Denver, Colorado, 80230, United States
As0005 2302
Brandon, Florida, 33511, United States
As0005 2321
Hagerstown, Maryland, 21742, United States
As0005 2312
Minot, North Dakota, 58701, United States
As0005 2323
Oklahoma City, Oklahoma, 73101, United States
As0005 2311
Duncansville, Pennsylvania, 16635, United States
As0005 2315
Jackson, Tennessee, 38305, United States
As0005 2303
Austin, Texas, 78731, United States
As0005 2318
Dallas, Texas, 75231, United States
As0005 1006
Genk, Belgium
As0005 1001
Ghent, Belgium
As0005 1004
Merksem, Belgium
As0005 1003
Mons, Belgium
As0005 1109
Pleven, Bulgaria
As0005 1103
Plovdiv, Bulgaria
As0005 1106
Plovdiv, Bulgaria
As0005 1111
Rousse, Bulgaria
As0005 1110
Sevlievo, Bulgaria
As0005 1101
Sofia, Bulgaria
As0005 1108
Sofia, Bulgaria
As0005 1308
Brno, Czechia
As0005 1309
Bruntál, Czechia
As0005 1301
Kladno, Czechia
As0005 1307
Ostrava, Czechia
As0005 1303
Pardubice, Czechia
As0005 1302
Prague, Czechia
As0005 1305
Prague, Czechia
As0005 1306
Prague, Czechia
As0005 1310
Prague, Czechia
As0005 1311
Prague, Czechia
As0005 1314
Prague, Czechia
As0005 1313
Uherské Hradiště, Czechia
As0005 1304
Zlín, Czechia
As0005 1504
Montpellier, France
As0005 1505
Orléans, France
As0005 1501
Paris, France
As0005 1503
Tours, France
As0005 1406
Berlin, Germany
As0005 1408
Berlin, Germany
As0005 1410
Berlin, Germany
As0005 1412
Berlin, Germany
As0005 1413
Bochum, Germany
As0005 1407
Cologne, Germany
As0005 1405
Erlangen, Germany
As0005 1404
Frankfurt am Main, Germany
As0005 1402
Hamburg, Germany
As0006 1409
Herne, Germany
As0005 1403
Leipzig, Germany
As0005 1705
Budapest, Hungary
As0005 1710
Budapest, Hungary
As0005 1704
Debrecen, Hungary
As0005 1706
Miskolc, Hungary
As0005 1711
Nyíregyháza, Hungary
As0005 1707
Szeged, Hungary
As0005 1702
Szentes, Hungary
As0005 1703
Szombathely, Hungary
As0005 1701
Veszprém, Hungary
As0005 2502
Amsterdam, Netherlands
As0005 2503
Rotterdam, Netherlands
As0005 2501
Sneek, Netherlands
As0005 1806
Bialystok, Poland
As0005 1805
Bydgoszcz, Poland
As0005 1801
Elblag, Poland
As0005 1802
Elblag, Poland
As0005 1812
Krakow, Poland
As0005 1808
Lodz, Poland
As0005 1814
Lodz, Poland
As0005 1803
Lublin, Poland
As0005 1816
Ostrowiec Świętokrzyski, Poland
As0005 1809
Poznan, Poland
As0005 1813
Poznan, Poland
As0005 1807
Torun, Poland
As0005 1804
Warsaw, Poland
As0005 1811
Warsaw, Poland
As0005 1815
Warsaw, Poland
As0005 1912
Brasov, Romania
As0005 1904
Brăila, Romania
As0005 1902
Bucharest, Romania
As0005 1903
Bucharest, Romania
As0005 1913
Bucharest, Romania
As0005 1907
Cluj-Napoca, Romania
As0005 1910
Iași, Romania
As0005 1911
Târgu Mureş, Romania
As0005 2403
Córdoba, Spain
As0005 2404
Getafe, Spain
As0005 2401
Madrid, Spain
As0005 2402
Seville, Spain
As0005 2205
Kaohsiung City, Taiwan
As0005 2201
Taichung, Taiwan
As0005 2202
Taichung, Taiwan
As0005 2203
Taipei, Taiwan
As0005 2204
Taipei, Taiwan
As0005 2206
Taipei, Taiwan
As0005 2101
Ankara, Turkey (Türkiye)
As0005 2103
Edirne, Turkey (Türkiye)
As0005 2102
Gaziantep, Turkey (Türkiye)
As0005 2105
Istanbul, Turkey (Türkiye)
As0005 2106
Istanbul, Turkey (Türkiye)
As0005 2104
Izmir, Turkey (Türkiye)
As0005 1603
Leeds, United Kingdom
As0005 1601
Norwich, United Kingdom
Related Publications (4)
Landewe RB, van der Heijde D, Dougados M, Baraliakos X, Van den Bosch FE, Gaffney K, Bauer L, Hoepken B, Davies OR, de Peyrecave N, Thomas K, Gensler LS. Maintenance of clinical remission in early axial spondyloarthritis following certolizumab pegol dose reduction. Ann Rheum Dis. 2020 Jul;79(7):920-928. doi: 10.1136/annrheumdis-2019-216839. Epub 2020 May 7.
PMID: 32381562BACKGROUNDProft F, Vahldiek JL, Nicolaes J, Tham R, Hoepken B, Ufuktepe B, Poddubnyy D, Bressem KK. Machine learning vs human experts: sacroiliitis analysis from the RAPID-axSpA and C-OPTIMISE phase 3 axSpA trials. Rheumatol Adv Pract. 2025 Apr 18;9(2):rkae118. doi: 10.1093/rap/rkae118. eCollection 2025.
PMID: 40256636DERIVEDBaraliakos X, Machado PM, Bauer L, Hoepken B, Kim M, Kumke T, Tham R, Rudwaleit M. Comparison of established and preliminarily proposed ASAS MRI working group cut-offs for inflammatory MRI lesions in the sacroiliac joints in radiographic and non-radiographic axial spondyloarthritis. RMD Open. 2024 Sep 3;10(3):e003886. doi: 10.1136/rmdopen-2023-003886.
PMID: 39231546DERIVEDLandewe R, van der Heijde D, Dougados M, Baraliakos X, Van den Bosch F, Gaffney K, Bauer L, Hoepken B, de Peyrecave N, Thomas K, Gensler LS. Induction of Sustained Clinical Remission in Early Axial Spondyloarthritis Following Certolizumab Pegol Treatment: 48-Week Outcomes from C-OPTIMISE. Rheumatol Ther. 2020 Sep;7(3):581-599. doi: 10.1007/s40744-020-00214-7. Epub 2020 Jun 11.
PMID: 32529495DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
+1 844 599 2273(UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
July 16, 2015
First Posted
July 22, 2015
Study Start
July 1, 2015
Primary Completion
February 1, 2019
Study Completion
April 1, 2019
Last Updated
December 17, 2020
Results First Posted
April 21, 2020
Record last verified: 2020-11