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

NCT00160602 | Completed Phase 3

• 2 other identifiers: C87050EudraCT Number: 2005-002326-63
• Study Type: interventional
• Target: 590
• Locations: 15 countries
• Sites: 70

Brief Summary

A 24 week study in which patients are given study medication and assessed for signs and symptoms of rheumatoid arthritis. X-rays are performed to assess the progress of joint damage during the study.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Certolizumab Pegol, Cimzia

Outcome Measures

Primary Outcomes (1)

• Compare efficacy of two dose regimens of certolizumab pegol in combination with MTX to MTX alone in patients with RA measured by the ACR20 at week 24.

Secondary Outcomes (1)

• Assess Safety and Tolerability of two dose regimens of certolizumab pegol in combination with MTX and MTX alone in patients with RA; prevention of joint damage in patients with RA; Health Outcomes Measures

Interventions

Certolizumab Pegol DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be at least 18 years old at the screening visit.
• 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:
• tender joints at Screening and Baseline.
• swollen joints at Screening and Baseline. and fulfilling 1 of the following 2 criteria during the screening period:
• 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after randomization even if they are no longer receiving study treatment in the present study, provided they have not withdrawn their informed consent.

You may not qualify if:

• Patients must not have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis).
• 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).

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (70)

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Montgomery, Alabama, United States

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Sun City West, Arizona, United States

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Palm Desert, California, United States

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Pasadena, California, United States

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Santa Maria, California, United States

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Naples, Florida, United States

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Palm Harbor, Florida, United States

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South Miami, Florida, United States

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New Orleans, Louisiana, United States

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St Louis, Missouri, United States

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New Brunswick, New Jersey, United States

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Stratford, New Jersey, United States

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New York, New York, United States

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Rochester, New York, United States

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Canfield, Ohio, United States

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Wynnewood, Pennsylvania, United States

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San Antonio, Texas, United States

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Pleven, Bulgaria

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Sofia, Bulgaria

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Stara Zagora, Bulgaria

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Santiago, Chile

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Temuco, Chile

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Rijeka, Croatia

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Brno, Czechia

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Hlučín, Czechia

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Ostrava-Poruba, Czechia

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Prague, Czechia

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Sokolov, Czechia

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UherskeHradiste, Czechia

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Zlín, Czechia

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Tallinn, Estonia

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Afula, Israel

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Ashkelon, Israel

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Beer Yaakov, Israel

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Haifa, Israel

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Jerusalem, Israel

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Ramat Gan, Israel

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Rehovot, Israel

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Daugavpils, Latvia

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Riga, Latvia

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Alytus, Lithuania

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Kaunas, Lithuania

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Klaipėda, Lithuania

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Panevezys, Lithuania

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Šiauliai, Lithuania

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D. F., Mexico

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Mexicalli, Mexico

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México, Mexico

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Monterrey, Mexico

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Tijuana, Mexico

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Bialystok, Poland

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Elblag, Poland

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Krakow, Poland

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Lublin, Poland

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Sopot, Poland

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Torun, Poland

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Moscow, Russia

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Saint Petersburg, Russia

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Yaroslavl, Russia

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Belgrade, Serbia

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Niška Banja, Serbia

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Novi Sad, Serbia

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Košice, Slovakia

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Piešťany, Slovakia

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Dnipro, Ukraine

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Donetsk, Ukraine

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Ivano-Frankivsk, Ukraine

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Kiev, Ukraine

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Simferopol, Ukraine

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Zaporizhzhya, Ukraine

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Related Publications (8)

• 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.

  PMID: 19015207 RESULT

• 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.

  PMID: 21415050 RESULT

• 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.

  PMID: 20547658 RESULT

• 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.

  PMID: 32100960 RESULT

• 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.

  PMID: 29246162 DERIVED

• 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.

  PMID: 26353833 DERIVED

• 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.

  PMID: 26238672 DERIVED

• 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.

  PMID: 19877104 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• UCB Clinical Trial Call Center

  UCB Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: June 1, 2005
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: December 1, 2020

Record last verified: 2020-11

Locations

US (17); CL (2); SL (2); LA (2); CR (1); PL (6); ES (1); BU (3); LI (5); RU (3); ME (5); IL (7); SE (3); UA (6); CZ (7)