Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo
NCT ID: NCT02505542
Last Updated: 2020-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
736 participants
INTERVENTIONAL
2015-07-31
2019-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Open-label Certolizumab Pegol
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). Subjects in sustained remission at Week 48 are eligible for randomization into Part B.
Certolizumab Pegol
* Active substance: Certolizumab Pegol
* Pharmaceutical form: Prefilled syringe
* Concentration: 200 mg / ml
* Route of Administration: Subcutaneous injection
Double-blind Certolizumab Pegol 200 mg Q2W
Certolizumab Pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.
Certolizumab Pegol
* Active substance: Certolizumab Pegol
* Pharmaceutical form: Prefilled syringe
* Concentration: 200 mg / ml
* Route of Administration: Subcutaneous injection
Double-blind Certolizumab Pegol 200 mg Q4W
Certolizumab 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.
Certolizumab Pegol
* Active substance: Certolizumab Pegol
* Pharmaceutical form: Prefilled syringe
* Concentration: 200 mg / ml
* Route of Administration: Subcutaneous injection
Placebo
* Active substance: Placebo
* Pharmaceutical form: Prefilled syringe
* Concentration: 0.9 % Saline
* Route of Administration: Subcutaneous injection
Placebo
One placebo injection is administered every 2 weeks from Week 48 onwards.
Placebo
* Active substance: Placebo
* Pharmaceutical form: Prefilled syringe
* Concentration: 0.9 % Saline
* Route of Administration: Subcutaneous injection
Placebo to CZP 200 mg Q2W escape
Subjects 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.
Certolizumab Pegol
* Active substance: Certolizumab Pegol
* Pharmaceutical form: Prefilled syringe
* Concentration: 200 mg / ml
* Route of Administration: Subcutaneous injection
Placebo
* Active substance: Placebo
* Pharmaceutical form: Prefilled syringe
* Concentration: 0.9 % Saline
* Route of Administration: Subcutaneous injection
CZP 200 mg Q4W to CZP 200 mg Q2W escape
Subjects 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.
Certolizumab Pegol
* Active substance: Certolizumab Pegol
* Pharmaceutical form: Prefilled syringe
* Concentration: 200 mg / ml
* Route of Administration: Subcutaneous injection
Placebo
* Active substance: Placebo
* Pharmaceutical form: Prefilled syringe
* Concentration: 0.9 % Saline
* Route of Administration: Subcutaneous injection
CZP 200 mg Q2W to CZP 200 mg Q2W escape
Subjects 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.
Certolizumab Pegol
* Active substance: Certolizumab Pegol
* Pharmaceutical form: Prefilled syringe
* Concentration: 200 mg / ml
* Route of Administration: Subcutaneous injection
Placebo
* Active substance: Placebo
* Pharmaceutical form: Prefilled syringe
* Concentration: 0.9 % Saline
* Route of Administration: Subcutaneous injection
Interventions
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Certolizumab Pegol
* Active substance: Certolizumab Pegol
* Pharmaceutical form: Prefilled syringe
* Concentration: 200 mg / ml
* Route of Administration: Subcutaneous injection
Placebo
* Active substance: Placebo
* Pharmaceutical form: Prefilled syringe
* Concentration: 0.9 % Saline
* Route of Administration: Subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
UCB BIOSCIENCES GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
+1 844 599 2273(UCB)
Locations
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As0005 2313
Glendale, Arizona, United States
As0005 2316
Mesa, Arizona, United States
As0005 2314
Phoenix, Arizona, United States
As0005 2317
Sun City, Arizona, United States
As0005 2307
Palm Desert, California, United States
As0005 2310
San Francisco, California, United States
As0005 2305
Upland, California, United States
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Denver, Colorado, United States
As0005 2302
Brandon, Florida, United States
As0005 2321
Hagerstown, Maryland, United States
As0005 2312
Minot, North Dakota, United States
As0005 2323
Oklahoma City, Oklahoma, United States
As0005 2311
Duncansville, Pennsylvania, United States
As0005 2315
Jackson, Tennessee, United States
As0005 2303
Austin, Texas, United States
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Dallas, Texas, United States
As0005 1006
Genk, , Belgium
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Ghent, , Belgium
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Merksem, , Belgium
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Mons, , Belgium
As0005 1109
Pleven, , Bulgaria
As0005 1103
Plovdiv, , Bulgaria
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
As0005 1110
Sevlievo, , Bulgaria
As0005 1101
Sofia, , Bulgaria
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Sofia, , Bulgaria
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Brno, , Czechia
As0005 1309
Bruntál, , Czechia
As0005 1301
Kladno, , Czechia
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Ostrava, , Czechia
As0005 1303
Pardubice, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
As0005 1310
Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Uherské Hradiště, , Czechia
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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
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Berlin, , Germany
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Bochum, , Germany
As0005 1407
Cologne, , Germany
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Erlangen, , Germany
As0005 1404
Frankfurt am Main, , Germany
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Hamburg, , Germany
As0006 1409
Herne, , Germany
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Leipzig, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Miskolc, , Hungary
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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
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Bucharest, , Romania
As0005 1903
Bucharest, , Romania
As0005 1913
Bucharest, , Romania
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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
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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
Countries
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References
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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.
Proft 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.
Baraliakos 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.
Landewe 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.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2015-000339-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AS0005
Identifier Type: -
Identifier Source: org_study_id