A Study of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis
NCT ID: NCT00160602
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
590 participants
INTERVENTIONAL
2005-06-30
2006-09-30
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
Eligibility Criteria
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Inclusion Criteria
* Patients must have a diagnosis of adult-onset RA of at least six months duration but not longer than fifteen years as defined by the 1987 American College of Rheumatology classification criteria.
* Patients must have active RA disease as defined by:
* 9 tender joints at Screening and Baseline.
* 9 swollen joints at Screening and Baseline. and fulfilling 1 of the following 2 criteria during the screening period:
* 30 mm/hour ESR (Westergren), or CRP \>15 mg/L.
* Patients must have received treatment with MTX (with or without folic acid) for at least 6 months prior to the Baseline visit. The dose of MTX and route of administration must have been stable for at least 2 months prior to the baseline visit. The minimum stable dose of MTX allowed is 10 mg weekly.
* Patients must be willing to complete an X-ray of the hands and feet 24 weeks after randomization even if they are no longer receiving study treatment in the present study, provided they have not withdrawn their informed consent.
Exclusion Criteria
* Patients must not have a secondary, non-inflammatory type of arthritis (e.g. OA or fibromyalgia)
* Female patients who are breast feeding, pregnant, or plan to become pregnant during the trial or for three months following last dose of study drug.
* Patients with a history of tuberculosis or positive chest X-ray for tuberculosis or positive
* Patients at a high risk of infection (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections and patients who are permanently bed ridden or wheelchair bound).
* Patients with known human immunodeficiency virus (HIV) infection.
* Patients with an active malignancy of any type or a history of malignancy (except basal cell carcinoma of the skin that has been excised prior to study start).
* Patients with a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient's participation in the trial.
* Patients with a history of, or suspected, demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis).
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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Montgomery, Alabama, United States
Sun City West, Arizona, United States
Palm Desert, California, United States
Pasadena, California, United States
Santa Maria, California, United States
Naples, Florida, United States
Palm Harbor, Florida, United States
South Miami, Florida, United States
New Orleans, Louisiana, United States
St Louis, Missouri, United States
New Brunswick, New Jersey, United States
Stratford, New Jersey, United States
New York, New York, United States
Rochester, New York, United States
Canfield, Ohio, United States
Wynnewood, Pennsylvania, United States
San Antonio, Texas, United States
Pleven, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Santiago, , Chile
Temuco, , Chile
Rijeka, , Croatia
Brno, , Czechia
Hlučín, , Czechia
Ostrava-Poruba, , Czechia
Prague, , Czechia
Sokolov, , Czechia
UherskeHradiste, , Czechia
Zlín, , Czechia
Tallinn, , Estonia
Afula, , Israel
Ashkelon, , Israel
Beer Yaakov, , Israel
Haifa, , Israel
Jerusalem, , Israel
Ramat Gan, , Israel
Rehovot, , Israel
Daugavpils, , Latvia
Riga, , Latvia
Alytus, , Lithuania
Kaunas, , Lithuania
Klaipėda, , Lithuania
Panevezys, , Lithuania
Šiauliai, , Lithuania
D. F., , Mexico
Mexicalli, , Mexico
México, , Mexico
Monterrey, , Mexico
Tijuana, , Mexico
Bialystok, , Poland
Elblag, , Poland
Krakow, , Poland
Lublin, , Poland
Sopot, , Poland
Torun, , Poland
Moscow, , Russia
Saint Petersburg, , Russia
Yaroslavl, , Russia
Belgrade, , Serbia
Niška Banja, , Serbia
Novi Sad, , Serbia
Košice, , Slovakia
Piešťany, , Slovakia
Dnipro, , Ukraine
Donetsk, , Ukraine
Ivano-Frankivsk, , Ukraine
Kiev, , Ukraine
Simferopol, , Ukraine
Zaporizhzhya, , Ukraine
Countries
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References
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Smolen J, Landewe RB, Mease P, Brzezicki J, Mason D, Luijtens K, van Vollenhoven RF, Kavanaugh A, Schiff M, Burmester GR, Strand V, Vencovsky J, van der Heijde D. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial. Ann Rheum Dis. 2009 Jun;68(6):797-804. doi: 10.1136/ard.2008.101659. Epub 2008 Nov 17.
Strand V, Smolen JS, van Vollenhoven RF, Mease P, Burmester GR, Hiepe F, Khanna D, Nikai E, Coteur G, Schiff M. Certolizumab pegol plus methotrexate provides broad relief from the burden of rheumatoid arthritis: analysis of patient-reported outcomes from the RAPID 2 trial. Ann Rheum Dis. 2011 Jun;70(6):996-1002. doi: 10.1136/ard.2010.143586. Epub 2011 Mar 17.
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.
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.
Smolen JS, van Vollenhoven R, Kavanaugh A, Strand V, Vencovsky J, Schiff M, Landewe R, Haraoui B, Arendt C, Mountian I, Carter D, van der Heijde D. Certolizumab pegol plus methotrexate 5-year results from the rheumatoid arthritis prevention of structural damage (RAPID) 2 randomized controlled trial and long-term extension in rheumatoid arthritis patients. Arthritis Res Ther. 2015 Sep 10;17(1):245. doi: 10.1186/s13075-015-0767-2.
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.
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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EudraCT Number: 2005-002326-63
Identifier Type: -
Identifier Source: secondary_id
C87050
Identifier Type: -
Identifier Source: org_study_id