Certolizumab Pegol in Subjects With Adult Onset Active and Progressive Psoriatic Arthritis
NCT ID: NCT01087788
Last Updated: 2018-08-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
409 participants
INTERVENTIONAL
2010-03-31
2015-08-31
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
DOUBLE
Study Groups
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CZP 200 mg Q2W
Subjects 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 200 mg Q2W
200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
Placebo
Matching Placebo to CZP injection.
CZP 400 mg Q4W
Subjects 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.
CZP 400 mg Q4W
400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
Placebo
Matching Placebo to CZP injection.
Placebo
Matching Placebo to Certolizumab Pegol (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 and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.
After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo
Matching Placebo to CZP injection.
Placebo to CZP 200 mg escape on Week 16
Matching 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.
CZP 200 mg Q2W
200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
Placebo
Matching Placebo to CZP injection.
Placebo to CZP 400 mg escape on Week 16
Matching 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.
CZP 400 mg Q4W
400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
Placebo
Matching Placebo to CZP injection.
Placebo to CZP 200 mg on Week 24
Matching 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.
CZP 200 mg Q2W
200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
Placebo
Matching Placebo to CZP injection.
Placebo to CZP 400 mg on Week 24
Matching 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.
CZP 400 mg Q4W
400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
Placebo
Matching Placebo to CZP injection.
Interventions
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CZP 200 mg Q2W
200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
CZP 400 mg Q4W
400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
Placebo
Matching Placebo to CZP injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active Psoriatic Skin Lesions or a documented history of Psoriasis
* Active Arthritis with ≥ 3 tender joints at Screening and Baseline, ≥ 3 swollen joints at Screening and Baseline and fulfilling at least 1 of the following 2 criteria during the Screening Period:
1. Erythrocyte Sedimentation Rate (ESR) (Westergren) ≥ 28 mm/hour
2. C-reactive protein (CRP) \> Upper Limit Normal (ULN)
* Failure to 1 or more treatment with Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
Exclusion Criteria
* Exposure to more than 1 Tumor Necrosis Factor α (TNFα) antagonist or to more than 2 previous biological response modifiers for PsA or Psoriasis
* Any non-biological systemic treatment of Psoriasis; phototherapy; topical agents
* History of chronic or recurrent infections
* High risk of infection
* Live vaccination within the 8 weeks prior to Baseline
* 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
* Clinically significant laboratory abnormalities
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 Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 UCB
Locations
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961
Birmingham, Alabama, United States
953
Tuscaloosa, Alabama, United States
954
Peoria, Arizona, United States
971
Scottsdale, Arizona, 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
958
Vero Beach, Florida, United States
964
Hagerstown, Maryland, United States
960
Kalamazoo, Michigan, 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
976
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
967
San Antonio, Texas, United States
968
Seattle, Washington, United States
700
Buenos Aires, , Argentina
704
Buenos Aires, , Argentina
707
Buenos Aires, , Argentina
705
Córdoba, , Argentina
706
Rosario, , Argentina
710
San Juan, , Argentina
702
San Miguel de Tucumán, , Argentina
708
San Miguel de Tucumán, , Argentina
152
Ghent, , Belgium
151
Liège, , Belgium
750
Curitiba, , Brazil
757
Goiás, , Brazil
761
Goiâna, , Brazil
753
Porto Alegre, , Brazil
907
Victoria, British Columbia, Canada
900
St. John's, Newfoundland and Labrador, Canada
904
Toronto, Ontario, Canada
910
Windsor, Ontario, Canada
905
Trois-Rivires, Quebec, Canada
504
Brno, , Czechia
501
Hlučín, , Czechia
500
Pardubice, , Czechia
502
Prague, , Czechia
505
Terezín, , Czechia
503
Zlín, , Czechia
206
Montpellier, , France
204
Paris, , France
202
Tours, , France
252
Bad Nauheim, , Germany
257
Berlin, , Germany
258
Berlin, , Germany
262
Frankfurt, , Germany
255
Freiburg im Breisgau, , Germany
254
Hamburg, , Germany
253
Leipzig, , Germany
263
München, , Germany
256
Ratingen, , Germany
303
Budapest, , Hungary
304
Budapest, , Hungary
302
Debrecen, , Hungary
301
Gyula, , Hungary
306
Miskolc, , Hungary
300
Veszprém, , Hungary
100
Dublin, , Ireland
352
Ancona, , Italy
350
Pisa, , Italy
802
Cuernavaca, , Mexico
803
Mexico City, , Mexico
458
Bialystok, , Poland
452
Dąbrówka, , Poland
455
Elblag, , Poland
459
Gdansk, , Poland
457
Krakow, , Poland
450
Lublin, , Poland
454
Poznan, , Poland
453
Torun, , Poland
456
Warsaw, , Poland
462
Warsaw, , Poland
555
Madrid, , Spain
550
Mérida, , Spain
552
Santiago de Compostela, , Spain
553
Seville, , Spain
605
Barnsley, , United Kingdom
602
London, , United Kingdom
601
Salford, , United Kingdom
Countries
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References
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Mease PJ, Fleischmann R, Deodhar AA, Wollenhaupt J, Khraishi M, Kielar D, Woltering F, Stach C, Hoepken B, Arledge T, van der Heijde D. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a Phase 3 double-blind randomised placebo-controlled study (RAPID-PsA). Ann Rheum Dis. 2014 Jan;73(1):48-55. doi: 10.1136/annrheumdis-2013-203696. Epub 2013 Aug 13.
van der Heijde D, Fleischmann R, Wollenhaupt J, Deodhar A, Kielar D, Woltering F, Stach C, Hoepken B, Arledge T, Mease PJ. Effect of different imputation approaches on the evaluation of radiographic progression in patients with psoriatic arthritis: results of the RAPID-PsA 24-week phase III double-blind randomised placebo-controlled study of certolizumab pegol. Ann Rheum Dis. 2014 Jan;73(1):233-7. doi: 10.1136/annrheumdis-2013-203697. Epub 2013 Aug 13.
van der Heijde D, Deodhar A, FitzGerald O, Fleischmann R, Gladman D, Gottlieb AB, Hoepken B, Bauer L, Irvin-Sellers O, Khraishi M, Peterson L, Turkiewicz A, Wollenhaupt J, Mease PJ. 4-year results from the RAPID-PsA phase 3 randomised placebo-controlled trial of certolizumab pegol in psoriatic arthritis. RMD Open. 2018 Mar 14;4(1):e000582. doi: 10.1136/rmdopen-2017-000582. eCollection 2018.
Walsh JA, Gottlieb AB, Hoepken B, Nurminen T, Mease PJ. Efficacy of certolizumab pegol with and without concomitant use of disease-modifying anti-rheumatic drugs over 4 years in psoriatic arthritis patients: results from the RAPID-PsA randomized controlled trial. Clin Rheumatol. 2018 Dec;37(12):3285-3296. doi: 10.1007/s10067-018-4227-7. Epub 2018 Sep 6.
van 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.
Osterhaus JT, Purcaru O. Discriminant validity, responsiveness and reliability of the arthritis-specific Work Productivity Survey assessing workplace and household productivity in patients with psoriatic arthritis. Arthritis Res Ther. 2014 Jul 4;16(4):R140. doi: 10.1186/ar4602.
Kavanaugh A, Gladman D, van der Heijde D, Purcaru O, Mease P. Improvements in productivity at paid work and within the household, and increased participation in daily activities after 24 weeks of certolizumab pegol treatment of patients with psoriatic arthritis: results of a phase 3 double-blind randomised placebo-controlled study. Ann Rheum Dis. 2015 Jan;74(1):44-51. doi: 10.1136/annrheumdis-2014-205198. Epub 2014 Jun 18.
Gladman D, Fleischmann R, Coteur G, Woltering F, Mease PJ. Effect of certolizumab pegol on multiple facets of psoriatic arthritis as reported by patients: 24-week patient-reported outcome results of a phase III, multicenter study. Arthritis Care Res (Hoboken). 2014 Jul;66(7):1085-92. doi: 10.1002/acr.22256.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2009-011720-59
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PsA001
Identifier Type: -
Identifier Source: org_study_id
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