Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS
NCT ID: NCT02552212
Last Updated: 2022-08-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
317 participants
INTERVENTIONAL
2015-09-30
2020-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Certolizumab Pegol 200 mg Q2W
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 onwards.
Certolizumab Pegol
* Active Substance: Certolizumab Pegol
* Pharmaceutical Form: Prefilled syringe
* Concentration: 200 mg / ml
* Route of Administration: Subcutaneous injection
Placebo
Matching placebo to Certolizumab Pegol (CZP) injections are administered every 2 weeks from Week 0 onwards.
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
* 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
* 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
18 Years
ALL
No
Sponsors
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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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As0006 125
Birmingham, Alabama, United States
As0006 120
Scottsdale, Arizona, United States
As0006 115
Tucson, Arizona, United States
As0006 155
Beverly Hills, California, United States
As0006 101
Palm Desert, California, United States
As0006 143
San Francisco, California, United States
As0006 160
New Haven, Connecticut, United States
As0006 117
Daytona Beach, Florida, United States
As0006 116
DeBary, Florida, United States
As0006 124
Fort Lauderdale, Florida, United States
As0006 133
New Port Richey, Florida, United States
As0006 138
Plantation, Florida, United States
As0006 134
Tampa, Florida, United States
As0006 106
Vero Beach, Florida, United States
As0006 148
Atlanta, Georgia, United States
As0006 137
Idaho Falls, Idaho, United States
As0006 102
Cumberland, Maryland, United States
As0006 141
Cumberland, Maryland, United States
As0006 111
Wheaton, Maryland, United States
As0006 127
Boston, Massachusetts, United States
As0006 147
Worcester, Massachusetts, United States
As0006 110
Eagan, Minnesota, United States
As0006 123
Rochester, Minnesota, United States
As0006 103
St Louis, Missouri, United States
As0006 114
Brooklyn, New York, United States
As0006 118
Charlotte, North Carolina, United States
As0006 149
Oklahoma City, Oklahoma, United States
As0006 105
Portland, Oregon, United States
As0006 108
Duncansville, Pennsylvania, United States
As0006 144
Philadelphia, Pennsylvania, United States
As0006 129
Wyomissing, Pennsylvania, United States
As0006 156
Orangeburg, South Carolina, United States
As0006 107
Salt Lake City, Utah, United States
As0006 104
Seattle, Washington, United States
As0006 158
Manitowoc, Wisconsin, United States
As0006 113
Onalaska, Wisconsin, United States
As0006 208
Camperdown, , Australia
As0006 210
Coffs Harbour, , Australia
As0006 204
Footscray, , Australia
As0006 201
Malvern East, , Australia
As0006 209
Maroochydore, , Australia
As0006 205
South Hobart, , Australia
As0006 202
Victoria Park, , Australia
As0006 302
Plovdiv, , Bulgaria
As0006 305
Plovdiv, , Bulgaria
As0006 304
Rousse, , Bulgaria
As0006 306
Sevlievo, , Bulgaria
As0006 300
Sofia, , Bulgaria
As0006 307
Sofia, , Bulgaria
As0006 309
Sofia, , Bulgaria
As0006 308
Varna, , Bulgaria
As0006 152
Edmonton, , Canada
As0006 150
Victoria, , Canada
As0006 326
Hlučín, , Czechia
As0006 324
Hustopeče, , Czechia
As0006 327
Olomouc, , Czechia
As0006 320
Ostrava, , Czechia
As0006 322
Pardubice, , Czechia
As0006 323
Prague, , Czechia
As0006 328
Prague, , Czechia
As0006 329
Prague, , Czechia
As0006 330
Prague, , Czechia
As0006 333
Příbor, , Czechia
As0006 332
Rychnov nad Kněžnou, , Czechia
As0006 331
Zlín, , Czechia
As0006 365
Balatonfüred, , Hungary
As0006 362
Budapest, , Hungary
As0006 363
Budapest, , Hungary
As0006 361
Székesfehérvár, , Hungary
As0006 406
Bydgoszcz, , Poland
As0006 400
Elblag, , Poland
As0006 401
Krakow, , Poland
As0006 402
Krakow, , Poland
As0006 411
Lublin, , Poland
As0006 403
Poznan, , Poland
As0006 404
Poznan, , Poland
As0006 405
Torun, , Poland
As0006 407
Warsaw, , Poland
As0006 408
Warsaw, , Poland
As0006 409
Warsaw, , Poland
As0006 410
Warsaw, , Poland
As0006 413
Wroclaw, , Poland
As0006 414
Wroclaw, , Poland
As0006 461
Chelyabinsk, , Russia
As0006 453
Ivanovo, , Russia
As0006 450
Kazan', , Russia
As0006 451
Kazan', , Russia
As0006 458
Kemerovo, , Russia
As0006 455
Moscow, , Russia
As0006 466
Moscow, , Russia
As0006 462
Orenburg, , Russia
As0006 452
Ryazan, , Russia
As0006 459
Saint Petersburg, , Russia
As0006 463
Saint Petersburg, , Russia
As0006 464
Saint Petersburg, , Russia
As0006 467
Saint Petersburg, , Russia
As0006 465
Samara, , Russia
As0006 454
Saratov, , Russia
As0006 460
Smolensk, , Russia
As0006 456
Tolyatti, , Russia
As0006 457
Yaroslavl, , Russia
As0006 232
Hualien City, , Taiwan
As0006 230
Taichung, , Taiwan
As0006 233
Taichung, , Taiwan
As0006 231
Taipei, , Taiwan
Countries
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References
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van der Heijde D, Gensler LS, Maksymowych WP, Landewe R, Rudwaleit M, Bauer L, Kumke T, Kim M, Auteri SE, Hoepken B, Deodhar A. Long-term safety and clinical outcomes of certolizumab pegol treatment in patients with active non-radiographic axial spondyloarthritis: 3-year results from the phase 3 C-axSpAnd study. RMD Open. 2022 Mar;8(1):e002138. doi: 10.1136/rmdopen-2021-002138.
Robinson PC, Maksymowych WP, Gensler LS, Hall S, Rudwaleit M, Hoepken B, Bauer L, Kumke T, Kim M, de Peyrecave N, Deodhar A. Certolizumab Pegol Efficacy in Patients With Non-Radiographic Axial Spondyloarthritis Stratified by Baseline MRI and C-Reactive Protein Status: An Analysis From the C-axSpAnd Study. ACR Open Rheumatol. 2022 Sep;4(9):794-801. doi: 10.1002/acr2.11469. Epub 2022 Jun 22.
Maksymowych WP, Kumke T, Auteri SE, Hoepken B, Bauer L, Rudwaleit M. Predictors of long-term clinical response in patients with non-radiographic axial spondyloarthritis receiving certolizumab pegol. Arthritis Res Ther. 2021 Oct 29;23(1):274. doi: 10.1186/s13075-021-02650-4.
Deodhar A, Gensler LS, Kay J, Maksymowych WP, Haroon N, Landewe R, Rudwaleit M, Hall S, Bauer L, Hoepken B, de Peyrecave N, Kilgallen B, van der Heijde D. A Fifty-Two-Week, Randomized, Placebo-Controlled Trial of Certolizumab Pegol in Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2019 Jul;71(7):1101-1111. doi: 10.1002/art.40866. Epub 2019 May 28.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2015-001894-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AS0006
Identifier Type: -
Identifier Source: org_study_id
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