Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis
Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis
2 other identifiers
interventional
325
15 countries
104
Brief Summary
The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of two dose regimens of Certolizumab Pegol (CZP) in subjects with active axial Spondyloarthritis (axial SpA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2010
Longer than P75 for phase_3
104 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
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 15, 2010
CompletedFirst Posted
Study publicly available on registry
March 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedResults Posted
Study results publicly available
December 25, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedAugust 1, 2018
November 1, 2016
1.6 years
March 15, 2010
November 6, 2013
July 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 12
The ASAS20 is defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains: * Patient's Global Assessment of Disease Activity * Pain assessment (total spinal pain) * Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) * Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain (deterioration is defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit).
Week 12
Secondary Outcomes (9)
Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 24
Week 24
Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12
From Baseline to Week 12
Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24
From Baseline to Week 24
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12
From Baseline to Week 12
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
From Baseline to Week 24
- +4 more secondary outcomes
Study Arms (7)
CZP 200 mg Q2W
EXPERIMENTALSubjects 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 onwards. At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
CZP 400 mg Q4W
EXPERIMENTALSubjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards. Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo
PLACEBO COMPARATORMatching Placebo to CZP injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16. After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg Q2W or CZP 400 mg Q4W.
Placebo to CZP 200 mg escape on Week 16
OTHERMatching Placebo to CZP injections from Week 0 to Week 16. Subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16 and were treated with three loading doses of CZP 400 mg sc on Weeks 16, 18 and 20, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 22 onwards. Additionally, Placebo injections were administered as appropriate in order to maintain the study blind.
Placebo to CZP 400 mg escape on Week 16
OTHERMatching Placebo to CZP injections from Week 0 to Week 16. Subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16 and were treated with three loading doses of CZP 400 mg sc on Weeks 16, 18 and 20, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 24 onwards. Additionally, Placebo injections were administered as appropriate in order to maintain the study blind.
Placebo to CZP 200 mg on Week 24
OTHERMatching Placebo to CZP injections from Week 0 to Week 24. Three loading doses of CZP 400 mg sc were given on Weeks 24, 26 and 28, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 30 onwards. Additionally, Placebo injections were administered as appropriate in order to maintain the study blind.
Placebo to CZP 400 mg on Week 24
OTHERMatching Placebo to CZP injections from Week 0 to Week 24. Three loading doses of CZP 400 mg sc were given on Weeks 24, 26 and 28, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 32 onwards. Additionally, Placebo injections were administered as appropriate in order to maintain the study blind.
Interventions
200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
Matching Placebo to CZP injection.
Eligibility Criteria
You may qualify if:
- Documented diagnosis of adult-onset axial Spondyloarthritis (SpA) of at least 3 months' duration as defined by the specified Assessment of Spondyloarthritis International Society (ASAS) criteria
- Active disease as defined by:
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4
- Back pain ≥ 4 on a 0 to 10 Neurobehavioral Rating Scale (NRS) (from BASDAI item 2)
- C-Reactive Protein (CRP) \> ULN (Upper Limit of Normal) and/or current evidence (ie, within the last 3 months from Screening) for Sacroiliitis on Magnetic Resonance Imaging (MRI) as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria
- Intolerance to or inadequate response to at least 1 Nonsteroidal Anti-Inflammatory Drug (NSAID)
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 to more than 2 previous biological agents for Axial Spondyloarthritis (SpA)
- 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
Study Sites (104)
961
Birmingham, Alabama, United States
953
Tuscaloosa, Alabama, United States
954
Peoria, Arizona, United States
971
Scottsdale, Arizona, United States
987
Tucson, Arizona, United States
974
La Jolla, California, United States
973
Los Angeles, California, United States
966
Palm Desert, California, United States
952
San Diego, California, United States
957
Aventura, Florida, United States
962
Fort Lauderdale, Florida, United States
959
Orange Park, Florida, United States
990
Pinellas Park, Florida, United States
958
Vero Beach, Florida, United States
964
Hagerstown, Maryland, United States
969
Eagan, Minnesota, United States
984
Flowood, Mississippi, United States
965
Florissant, Missouri, United States
950
St Louis, Missouri, United States
985
Brooklyn, New York, United States
963
Asheville, North Carolina, United States
977
Cleveland, Ohio, United States
951
Middleburg Heights, Ohio, United States
970
Oklahoma City, Oklahoma, United States
982
Portland, Oregon, United States
972
Duncansville, Pennsylvania, United States
975
Dallas, Texas, United States
978
Houston, Texas, United States
983
Houston, Texas, United States
967
San Antonio, Texas, United States
981
Salt Lake City, Utah, United States
968
Seattle, Washington, United States
700
Buenos Aires, Argentina
701
Buenos Aires, Argentina
704
Buenos Aires, Argentina
705
Córdoba, Argentina
709
La Plata, Argentina
706
Rosario, Argentina
710
San Juan, Argentina
702
San Miguel de Tucumán, Argentina
708
San Miguel de Tucumán, Argentina
153
Brussels, Belgium
152
Ghent, Belgium
151
Liège, Belgium
760
Campinas, Brazil
750
Curitiba, Brazil
761
Goiânia, Brazil
756
São Paulo, Brazil
907
Victoria, British Columbia, Canada
903
Winnipeg, Manitoba, Canada
900
St. John's, Newfoundland and Labrador, Canada
910
Windsor, Ontario, Canada
902
Sainte-Foy, Quebec, Canada
504
Brno, Czechia
501
Hlučín, Czechia
500
Pardubice, Czechia
502
Prague, Czechia
505
Terezín, Czechia
503
Zlín, Czechia
200
Boulogne-Billan Court, France
201
Lille, France
205
Limoges, France
206
Montpellier, France
204
Paris, France
202
Tours, France
257
Berlin, Germany
258
Berlin, Germany
255
Freiburg im Breisgau, Germany
254
Hamburg, Germany
250
Herne, Germany
253
Leipzig, Germany
260
München, Germany
263
München, Germany
256
Ratingen, Germany
303
Budapest, Hungary
305
Budapest, Hungary
302
Debrecen, Hungary
306
Miskolc, Hungary
300
Veszprém, Hungary
352
Ancona, Italy
351
Florence, Italy
350
Pisa, Italy
802
Cuernavaca, Mexico
801
Monterrey, Mexico
401
Maastricht, Netherlands
400
Rotterdam, Netherlands
458
Bialystok, Poland
452
Dąbrówka, Poland
455
Elblag, Poland
459
Gdanks, Poland
457
Krakow, Poland
450
Lublin, Poland
454
Poznan, Poland
453
Torun, Poland
456
Warsaw, Poland
462
Warsaw, Poland
550
Mérida, Spain
554
Santander, Spain
552
Santiago de Compostela, Spain
553
Seville, Spain
605
Barnsley, United Kingdom
600
Leeds, United Kingdom
602
London, United Kingdom
601
Salford, United Kingdom
Related Publications (12)
Landewe R, Braun J, Deodhar A, Dougados M, Maksymowych WP, Mease PJ, Reveille JD, Rudwaleit M, van der Heijde D, Stach C, Hoepken B, Fichtner A, Coteur G, de Longueville M, Sieper J. Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 study. Ann Rheum Dis. 2014 Jan;73(1):39-47. doi: 10.1136/annrheumdis-2013-204231. Epub 2013 Sep 6.
PMID: 24013647RESULTProft 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: 40256636DERIVEDRudwaleit M, Marzo-Ortega H, Navarro-Compan V, Tham R, Kumke T, Bauer L, de Peyrecave N, Kim M, Van den Bosch F. Exploratory analysis of the potential disconnect between objective inflammatory response and clinical response following certolizumab pegol treatment in patients with active axial spondyloarthritis. RMD Open. 2024 Aug 28;10(3):e004369. doi: 10.1136/rmdopen-2024-004369.
PMID: 39209369DERIVEDBaraliakos X, Kruse S, Auteri SE, de Peyrecave N, Nurminen T, Kumke T, Hoepken B, Braun J. Certolizumab pegol treatment in axial spondyloarthritis mitigates fat lesion development: 4-year post-hoc MRI results from a phase 3 study. Rheumatology (Oxford). 2022 Jul 6;61(7):2875-2885. doi: 10.1093/rheumatology/keab841.
PMID: 34791107DERIVEDLandewe R, Nurminen T, Davies O, Baeten D. A single determination of C-reactive protein does not suffice to declare a patient with a diagnosis of axial spondyloarthritis 'CRP-negative'. Arthritis Res Ther. 2018 Sep 14;20(1):209. doi: 10.1186/s13075-018-1707-8.
PMID: 30217232DERIVEDvan der Heijde D, Braun J, Rudwaleit M, Purcaru O, Kavanaugh AF. Improvements in workplace and household productivity with certolizumab pegol treatment in axial spondyloarthritis: results to week 96 of a phase III study. RMD Open. 2018 Apr 9;4(1):e000659. doi: 10.1136/rmdopen-2018-000659. eCollection 2018.
PMID: 29670761DERIVEDvan der Heijde D, Baraliakos X, Hermann KA, Landewe RBM, Machado PM, Maksymowych WP, Davies OR, de Peyrecave N, Hoepken B, Bauer L, Nurminen T, Braun J. Limited radiographic progression and sustained reductions in MRI inflammation in patients with axial spondyloarthritis: 4-year imaging outcomes from the RAPID-axSpA phase III randomised trial. Ann Rheum Dis. 2018 May;77(5):699-705. doi: 10.1136/annrheumdis-2017-212377. Epub 2018 Jan 17.
PMID: 29343510DERIVEDBraun J, Baraliakos X, Hermann KG, Landewe R, Machado PM, Maksymowych WP, Davies O, Hoepken B, Nurminen T, Stach C, van der Heijde D. Effect of certolizumab pegol over 96 weeks of treatment on inflammation of the spine and sacroiliac joints, as measured by MRI, and the association between clinical and MRI outcomes in patients with axial spondyloarthritis. RMD Open. 2017 Apr 24;3(1):e000430. doi: 10.1136/rmdopen-2017-000430. eCollection 2017.
PMID: 28848654DERIVEDvan der Heijde D, Dougados M, Landewe R, Sieper J, Maksymowych WP, Rudwaleit M, Van den Bosch F, Braun J, Mease PJ, Kivitz AJ, Walsh J, Davies O, Bauer L, Hoepken B, Peterson L, Deodhar A. Sustained efficacy, safety and patient-reported outcomes of certolizumab pegol in axial spondyloarthritis: 4-year outcomes from RAPID-axSpA. Rheumatology (Oxford). 2017 Sep 1;56(9):1498-1509. doi: 10.1093/rheumatology/kex174.
PMID: 28498975DERIVEDvan der Heijde D, Deodhar A, Fleischmann R, Mease PJ, Rudwaleit M, Nurminen T, Davies O. Early Disease Activity or Clinical Response as Predictors of Long-Term Outcomes With Certolizumab Pegol in Axial Spondyloarthritis or Psoriatic Arthritis. Arthritis Care Res (Hoboken). 2017 Jul;69(7):1030-1039. doi: 10.1002/acr.23092. Epub 2017 Jun 2.
PMID: 27696727DERIVEDRudwaleit M, Rosenbaum JT, Landewe R, Marzo-Ortega H, Sieper J, van der Heijde D, Davies O, Bartz H, Hoepken B, Nurminen T, Deodhar A. Observed Incidence of Uveitis Following Certolizumab Pegol Treatment in Patients With Axial Spondyloarthritis. Arthritis Care Res (Hoboken). 2016 Jun;68(6):838-44. doi: 10.1002/acr.22848.
PMID: 26815944DERIVEDSieper J, Kivitz A, van Tubergen A, Deodhar A, Coteur G, Woltering F, Landewe R. Impact of Certolizumab Pegol on Patient-Reported Outcomes in Patients With Axial Spondyloarthritis. Arthritis Care Res (Hoboken). 2015 Oct;67(10):1475-80. doi: 10.1002/acr.22594.
PMID: 25832312DERIVED
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 Clinical Trial Call Center
+1 877 822 9493 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
March 15, 2010
First Posted
March 16, 2010
Study Start
March 1, 2010
Primary Completion
October 1, 2011
Study Completion
August 1, 2015
Last Updated
August 1, 2018
Results First Posted
December 25, 2013
Record last verified: 2016-11