Clinical trial NCT01087788: Certolizumab Pegol in Subjects With Adult Onset Active and Progressive Psoriatic Arthritis
Official title: Phase 3, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Adult-Onset Active and Progressive Psoriatic Arthritis (PsA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Psoriatic
Keywords: Certolizumab Pegol
Cimzia
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2010-03-16
Enrollment: 409
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in subjects with adult onset active and progressive Psoriatic Arthritis (PsA).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of adult-onset Psoriatic Arthritis (PsA) of at least 6 months' duration as defined by the Classification Criteria for Psoriatic Arthritis (CASPAR 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:

* Diagnosis of any other inflammatory Arthritis or known diagnosis of Fibromyalgia
* 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

Primary outcomes:
measure: American College of Rheumatology 20 (ACR20) Response at Week 12
timeFrame: Week 12
measure: Change From Baseline in Modified Total Sharp Score (mTSS) in Modification for Psoriatic Arthritis at Week 24
timeFrame: From Baseline to Week 24
Secondary outcomes:
measure: American College of Rheumatology 20 (ACR20) Response at Week 24
timeFrame: Week 24
measure: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 24
timeFrame: From Baseline to Week 24
measure: Psoriasis Area Severity Index (PASI75) Response at Week 24 in the Subgroup of Subjects With Psoriasis (PSO) Involving at Least 3 % Body Surface Area (BSA) at Baseline
timeFrame: Week 24
measure: Change From Baseline in Modified Total Sharp Score (mTSS) at Week 48
timeFrame: From Baseline to Week 48
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 961
state: Alabama
city: Tuscaloosa
country: United States
facility: 953
state: Alabama
city: Peoria
country: United States
facility: 954
state: Arizona
city: Scottsdale
country: United States
facility: 971
state: Arizona
city: Palm Desert
country: United States
facility: 966
state: California
city: San Diego
country: United States
facility: 952
state: California
city: Aventura
country: United States
facility: 957
state: Florida
city: Fort Lauderdale
country: United States
facility: 962
state: Florida
city: Orange Park
country: United States
facility: 959
state: Florida
city: Vero Beach
country: United States
facility: 958
state: Florida
city: Hagerstown
country: United States
facility: 964
state: Maryland
city: Kalamazoo
country: United States
facility: 960
state: Michigan
city: Eagan
country: United States
facility: 969
state: Minnesota
city: Flowood
country: United States
facility: 984
state: Mississippi
city: Florissant
country: United States
facility: 965
state: Missouri
city: Saint Louis
country: United States
facility: 950
state: Missouri
city: Brooklyn
country: United States
facility: 985
state: New York
city: Asheville
country: United States
facility: 963
state: North Carolina
city: Cleveland
country: United States
facility: 976
state: Ohio
city: Middleburg Heights
country: United States
facility: 951
state: Ohio
city: Oklahoma City
country: United States
facility: 970
state: Oklahoma
city: Portland
country: United States
facility: 982
state: Oregon
city: Duncansville
country: United States
facility: 972
state: Pennsylvania
city: Dallas
country: United States
facility: 975
state: Texas
city: Houston
country: United States
facility: 978
state: Texas
city: San Antonio
country: United States
facility: 967
state: Texas
city: Seattle
country: United States
facility: 968
state: Washington
city: Buenos Aires
country: Argentina
facility: 700
city: Buenos Aires
country: Argentina
facility: 704
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: 707
city: Cordoba
country: Argentina
facility: 705
city: Rosario
country: Argentina
facility: 706
city: San Juan
country: Argentina
facility: 710
city: San Miguel De Tucuman
country: Argentina
facility: 702
city: San Miguel de Tucuman
country: Argentina
facility: 708
city: Gent
country: Belgium
facility: 152
city: Liege
country: Belgium
facility: 151
city: Curitiba
country: Brazil
facility: 750
city: Goias
country: Brazil
facility: 757
city: Goiâna
country: Brazil
facility: 761
city: Porto Alegre
country: Brazil
facility: 753
city: Victoria
country: Canada
facility: 907
state: British Columbia
city: St. John's
country: Canada
facility: 900
state: Newfoundland and Labrador
city: Toronto
country: Canada
facility: 904
state: Ontario
city: Windsor
country: Canada
facility: 910
state: Ontario
city: Trois-Rivires
country: Canada
facility: 905
state: Quebec
city: Brno
country: Czechia
facility: 504
city: Hlucin
country: Czechia
facility: 501
city: Pardubice
country: Czechia
facility: 500
city: Praha 2
country: Czechia
facility: 502
city: Terezin
country: Czechia
facility: 505
city: Zlin
country: Czechia
facility: 503
city: Montpellier
country: France
facility: 206
city: Paris
country: France
facility: 204
city: Tours
country: France
facility: 202
city: Bad Nauheim
country: Germany
facility: 252
city: Berlin
country: Germany
facility: 257
city: Berlin
country: Germany
facility: 258
city: Frankfurt
country: Germany
facility: 262
city: Freiburg
country: Germany
facility: 255
city: Hamburg
country: Germany
facility: 254
city: Leipzig
country: Germany
facility: 253
city: München
country: Germany
facility: 263
city: Ratingen
country: Germany
facility: 256
city: Budapest
country: Hungary
facility: 303
city: Budapest
country: Hungary
facility: 304
city: Debrecen
country: Hungary
facility: 302
city: Gyula
country: Hungary
facility: 301
city: Miskolc
country: Hungary
facility: 306
city: Veszprém
country: Hungary
facility: 300
city: Dublin 4
country: Ireland
facility: 100
city: Ancona
country: Italy
facility: 352
city: Pisa
country: Italy
facility: 350
city: Cuernavaca
country: Mexico
facility: 802
city: Mexico D.F.
country: Mexico
facility: 803
city: Bialystok
country: Poland
facility: 458
city: Dabrowka
country: Poland
facility: 452
city: Elblag
country: Poland
facility: 455
city: Gdansk
country: Poland
facility: 459
city: Krakow
country: Poland
facility: 457
city: Lublin
country: Poland
facility: 450
city: Poznan
country: Poland
facility: 454
city: Torun
country: Poland
facility: 453
city: Warszawa
country: Poland
facility: 456
city: Warszawa
country: Poland
facility: 462
city: Madrid
country: Spain
facility: 555
city: Mérida
country: Spain
facility: 550
city: Santiago de Compostela
country: Spain
facility: 552
city: Sevilla
country: Spain
facility: 553
city: Barnsley
country: United Kingdom
facility: 605
city: London
country: United Kingdom
facility: 602
city: Salford
country: United Kingdom
facility: 601
Study officials:
affiliation: +1 877 822 9493 UCB
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.