A Placebo Controlled Study to Assess Efficacy and Safety of Certolizumab Pegol in the Treatment of Rheumatoid Arthritis
NCT ID: NCT00152386
Last Updated: 2020-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
950 participants
INTERVENTIONAL
2005-02-28
2006-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Certolizumab pegol (CDP870)
Eligibility Criteria
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Inclusion Criteria
* A clear chest X-ray within 3 months prior to Baseline visit.
* A diagnosis of adult-onset RA (of at least six months duration but not longer than 15 years prior to Screening) as defined by the 1987 American College of Rheumatology classification criteria.
* Active RA disease at Screening and Baseline as defined by:
* ≥9 tender joints.
* ≥9 swollen joints. and fulfilling 1 of the following 2 criteria:
* ≥30 mm/hour ESR (Westergren), or
* CRP \>15 mg/L.
* Must have received a stable dose of MTX with or without folic acid for at least 3 months prior to Baseline visit. The minimum dose is 10 mg MTX weekly.
* Patient must be willing to attend for a Week 52 X-ray of the hands and feet even if they are no longer receiving study treatment but have not withdrawn their informed consent.
Exclusion Criteria
* A secondary, non-inflammatory type of arthritis (e.g. OA or fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of CDP870 on the patient's primary diagnosis of RA.
* A history of an infected joint prosthesis at any time with prosthesis still in situ.
* Does not meet exclusionary concomitant medication criteria.
* A history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time.
* Patients at a high risk of infection in the Investigator's opinion (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections).
18 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
UCB Pharma
Locations
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Huntsville, Alabama, United States
Paradise Valley, Arizona, United States
La Jolla, California, United States
San Diego, California, United States
Denver, Colorado, United States
Danbury, Connecticut, United States
Washington D.C., District of Columbia, United States
Aventura, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Coeur d'Alene, Idaho, United States
Springfield, Illinois, United States
Wichita, Kansas, United States
Wheaton, Maryland, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Charlotte, North Carolina, United States
Cleveland, Ohio, United States
Dayton, Ohio, United States
Duncansville, Pennsylvania, United States
Charleston, South Carolina, United States
Austin, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Capital Federal, , Argentina
Córdoba, , Argentina
Camperdown, , Australia
Coffs Harbour, , Australia
Cotton Tree, , Australia
Malvern, , Australia
Shenton Park, , Australia
Victoria Park, , Australia
Westmead, , Australia
Wooloongabba, , Australia
Antwerp, , Belgium
Brussels, , Belgium
Liège, , Belgium
Merksem, , Belgium
Sijsele, , Belgium
Pleven, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Varna, , Bulgaria
Courtice, , Canada
Hamilton, , Canada
Kitchener, , Canada
London, , Canada
Mississauga, , Canada
Montreal, , Canada
Newmarket, , Canada
Point Claire, , Canada
Sainte-Foy, , Canada
Toronto, , Canada
Winnipeg, , Canada
Valdivia, Las Condes, Chile
Santiago, Santiago Centro, Chile
Santiago, , Chile
Temuco, , Chile
Rijeka, , Croatia
Brno, , Czechia
Brno Bohunice, , Czechia
Ostrava Trebovice, , Czechia
Pilsen, , Czechia
Prague, , Czechia
Uherské Hradiště, , Czechia
Zlín, , Czechia
Afula, , Israel
Haifa, , Israel
Ramat Gan, , Israel
Tel Aviv, , Israel
Riga, , Latvia
Moscow, , Russia
Saint Petersburg, , Russia
Ivano-Frankivsk, , Ukraine
Countries
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References
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Keystone E, Heijde Dv, Mason D Jr, Landewe R, Vollenhoven RV, Combe B, Emery P, Strand V, Mease P, Desai C, Pavelka K. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum. 2008 Nov;58(11):3319-29. doi: 10.1002/art.23964.
van Vollenhoven RF, Felson D, Strand V, Weinblatt ME, Luijtens K, Keystone EC. American College of Rheumatology hybrid analysis of certolizumab pegol plus methotrexate in patients with active rheumatoid arthritis: data from a 52-week phase III trial. Arthritis Care Res (Hoboken). 2011 Jan;63(1):128-34. doi: 10.1002/acr.20331.
Hazes JM, Taylor P, Strand V, Purcaru O, Coteur G, Mease P. Physical function improvements and relief from fatigue and pain are associated with increased productivity at work and at home in rheumatoid arthritis patients treated with certolizumab pegol. Rheumatology (Oxford). 2010 Oct;49(10):1900-10. doi: 10.1093/rheumatology/keq109. Epub 2010 Jun 14.
Pincus T, Furer V, Keystone E, Yazici Y, Bergman MJ, Luijtens K. RAPID3 (Routine Assessment of Patient Index Data 3) severity categories and response criteria: Similar results to DAS28 (Disease Activity Score) and CDAI (Clinical Disease Activity Index) in the RAPID 1 (Rheumatoid Arthritis Prevention of Structural Damage) clinical trial of certolizumab pegol. Arthritis Care Res (Hoboken). 2011 Aug;63(8):1142-9. doi: 10.1002/acr.20481.
Curtis JR, Chen L, Luijtens K, Navarro-Millan I, Goel N, Gervitz L, Weinblatt M. Dose escalation of certolizumab pegol from 200 mg to 400 mg every other week provides no additional efficacy in rheumatoid arthritis: an analysis of individual patient-level data. Arthritis Rheum. 2011 Aug;63(8):2203-8. doi: 10.1002/art.30387.
Keystone EC, Curtis JR, Fleischmann RM, Furst DE, Khanna D, Smolen JS, Mease PJ, Schiff MH, Coteur G, Davies O, Combe B. Rapid improvement in the signs and symptoms of rheumatoid arthritis following certolizumab pegol treatment predicts better longterm outcomes: post-hoc analysis of a randomized controlled trial. J Rheumatol. 2011 Jun;38(6):990-6. doi: 10.3899/jrheum.100935. Epub 2011 Mar 1.
Curtis JR, Luijtens K, Kavanaugh A. Predicting future response to certolizumab pegol in rheumatoid arthritis patients: features at 12 weeks associated with low disease activity at 1 year. Arthritis Care Res (Hoboken). 2012 May;64(5):658-67. doi: 10.1002/acr.21600.
Paul S, Marotte H, Kavanaugh A, Goupille P, Kvien TK, de Longueville M, Mulleman D, Sandborn WJ, Vande Casteele N. Exposure-Response Relationship of Certolizumab Pegol and Achievement of Low Disease Activity and Remission in Patients With Rheumatoid Arthritis. Clin Transl Sci. 2020 Jul;13(4):743-751. doi: 10.1111/cts.12760. Epub 2020 Apr 1.
Curtis JR, Winthrop K, O'Brien C, Ndlovu MN, de Longueville M, Haraoui B. Use of a baseline risk score to identify the risk of serious infectious events in patients with rheumatoid arthritis during certolizumab pegol treatment. Arthritis Res Ther. 2017 Dec 15;19(1):276. doi: 10.1186/s13075-017-1466-y.
Combe B, Furst DE, Keystone EC, van der Heijde D, Luijtens K, Ionescu L, Goel N, Emery P. Certolizumab Pegol Efficacy Across Methotrexate Regimens: A Pre-Specified Analysis of Two Phase III Trials. Arthritis Care Res (Hoboken). 2016 Mar;68(3):299-307. doi: 10.1002/acr.22676.
van der Heijde D, Keystone EC, Curtis JR, Landewe RB, Schiff MH, Khanna D, Kvien TK, Ionescu L, Gervitz LM, Davies OR, Luijtens K, Furst DE. Timing and magnitude of initial change in disease activity score 28 predicts the likelihood of achieving low disease activity at 1 year in rheumatoid arthritis patients treated with certolizumab pegol: a post-hoc analysis of the RAPID 1 trial. J Rheumatol. 2012 Jul;39(7):1326-33. doi: 10.3899/jrheum.111171. Epub 2012 May 15.
Strand V, Mease P, Burmester GR, Nikai E, Coteur G, van Vollenhoven R, Combe B, Keystone EC, Kavanaugh A. Rapid and sustained improvements in health-related quality of life, fatigue, and other patient-reported outcomes in rheumatoid arthritis patients treated with certolizumab pegol plus methotrexate over 1 year: results from the RAPID 1 randomized controlled trial. Arthritis Res Ther. 2009;11(6):R170. doi: 10.1186/ar2859. Epub 2009 Nov 12.
Kavanaugh A, Smolen JS, Emery P, Purcaru O, Keystone E, Richard L, Strand V, van Vollenhoven RF. Effect of certolizumab pegol with methotrexate on home and work place productivity and social activities in patients with active rheumatoid arthritis. Arthritis Rheum. 2009 Nov 15;61(11):1592-600. doi: 10.1002/art.24828.
Other Identifiers
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2004-002993-49
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C87027
Identifier Type: -
Identifier Source: org_study_id