Clinical trial NCT01087762: Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis
Official title: Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spondyloarthropathies
Keywords: Certolizumab Pegol
Cimzia
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2010-03-16
Enrollment: 325
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: 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).


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
* Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion in the study

Primary outcomes:
measure: Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 24
timeFrame: Week 24
measure: Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12
timeFrame: From Baseline to Week 12
measure: Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24
timeFrame: From Baseline to Week 24
measure: Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12
timeFrame: From Baseline to Week 12
measure: Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
timeFrame: From Baseline to Week 24
measure: Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12
timeFrame: From Baseline to Week 12
measure: Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 24
timeFrame: From Baseline to Week 24
measure: Change From Baseline in the Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging (MRI) Scoring System for Disease Activity (ASspiMRI-a) in the Berlin Modification at Week 12
timeFrame: From Baseline to Week 12
measure: Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 12
timeFrame: From Baseline to Week 12
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: Tucson
country: United States
facility: 987
state: Arizona
city: La Jolla
country: United States
facility: 974
state: California
city: Los Angeles
country: United States
facility: 973
state: California
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: Pinellas Park
country: United States
facility: 990
state: Florida
city: Vero Beach
country: United States
facility: 958
state: Florida
city: Hagerstown
country: United States
facility: 964
state: Maryland
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: 977
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: Houston
country: United States
facility: 983
state: Texas
city: San Antonio
country: United States
facility: 967
state: Texas
city: Salt Lake City
country: United States
facility: 981
state: Utah
city: Seattle
country: United States
facility: 968
state: Washington
city: Buenos Aires
country: Argentina
facility: 700
city: Buenos Aires
country: Argentina
facility: 701
city: Buenos Aires
country: Argentina
facility: 704
city: Cordoba
country: Argentina
facility: 705
city: La Plata
country: Argentina
facility: 709
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: Brussels
country: Belgium
facility: 153
city: Gent
country: Belgium
facility: 152
city: Liege
country: Belgium
facility: 151
city: Campinas
country: Brazil
facility: 760
city: Curitiba
country: Brazil
facility: 750
city: Goiânia
country: Brazil
facility: 761
city: Sao Paulo
country: Brazil
facility: 756
city: Victoria
country: Canada
facility: 907
state: British Columbia
city: Winnipeg
country: Canada
facility: 903
state: Manitoba
city: St. John's
country: Canada
facility: 900
state: Newfoundland and Labrador
city: Windsor
country: Canada
facility: 910
state: Ontario
city: Sainte Foy
country: Canada
facility: 902
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: Boulogne-Billan Court
country: France
facility: 200
city: Lille
country: France
facility: 201
city: Limoges
country: France
facility: 205
city: Montpellier
country: France
facility: 206
city: Paris
country: France
facility: 204
city: Tours
country: France
facility: 202
city: Berlin
country: Germany
facility: 257
city: Berlin
country: Germany
facility: 258
city: Freiburg
country: Germany
facility: 255
city: Hamburg
country: Germany
facility: 254
city: Herne
country: Germany
facility: 250
city: Leipzig
country: Germany
facility: 253
city: München
country: Germany
facility: 260
city: München
country: Germany
facility: 263
city: Ratingen
country: Germany
facility: 256
city: Budapest
country: Hungary
facility: 303
city: Budapest
country: Hungary
facility: 305
city: Debrecen
country: Hungary
facility: 302
city: Miskolc
country: Hungary
facility: 306
city: Veszprém
country: Hungary
facility: 300
city: Ancona
country: Italy
facility: 352
city: Firenze
country: Italy
facility: 351
city: Pisa
country: Italy
facility: 350
city: Cuernavaca
country: Mexico
facility: 802
city: Monterrey
country: Mexico
facility: 801
city: Maastricht
country: Netherlands
facility: 401
city: Rotterdam
country: Netherlands
facility: 400
city: Bialystok
country: Poland
facility: 458
city: Dabrowka
country: Poland
facility: 452
city: Elblag
country: Poland
facility: 455
city: Gdanks
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: Mérida
country: Spain
facility: 550
city: Santander
country: Spain
facility: 554
city: Santiago de Compostela
country: Spain
facility: 552
city: Sevilla
country: Spain
facility: 553
city: Barnsley
country: United Kingdom
facility: 605
city: Leeds
country: United Kingdom
facility: 600
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: 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.
citation: Baraliakos 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.
citation: Landewe 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.
citation: van 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.
citation: van 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.
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: Rudwaleit 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.
citation: Sieper 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.