An open ended study in which patients who completed the double-blind study (CDP870-050) are given Certolizumab pegol every 2 weeks and assessed for signs and symptoms of rheumatoid arthritis. X-rays are performed to assess the progress of joint damage during the study.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Certolizumab Pegol	Phase III

Further Study Details: 

Primary Outcomes: To assess the safety of the liquid formulation of certolizumab pegol, dosed at 400mg s.c. every two weeks, in patients with active rheumatoid arthritis (RA) by measuring ACR 20/50/70 responder rates every 12 weeks
Secondary Outcomes: To assess the tolerability and efficacy of liquid certolizumab pegol dosed at 400mg every two weeks in patients with active RA.; To assess the effect of liquid certolizumab pegol dosed at 400mg every two weeks on physical function and Health Outcome measures.; To monitor the pharmacokinetic and immunogenicity profile of liquid certolizumab pegol
Expected Total Enrollment:  450

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients must have either failed to achieve an ACR20 response at Week 12 (confirmed at Week 14) in the CDP870-050 trial or must have completed the entire CDP870-050 trial through Week 24.

• Patients must have a clear chest X-ray at the Entry visit (Week 24 Completion/Week 16 Withdrawal visit of CDP870-050).

• Patients must continue treatment on methotrexate with or without folic acid throughout the study, unless given prior approval by UCB for discontinuation.

Exclusion Criteria:

• 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) that, in the Investigator’s opinion is symptomatic enough to interfere with evaluation of the effect of liquid certolizumab pegol on the patient’s primary diagnosis of RA.

• Female patients who are breast feeding, pregnant, or plan to become pregnant during the study and for 12 weeks following the last dose of study drug.

• Patients at a high risk of infection in the Investigator’s opinion (e.g. patients with leg ulcers, indwelling urinary catheter, persistent or recurrent chest infections, and patients who are permanently bed ridden or wheelchair bound).

• Patients with a history of tuberculosis or positive chest X-ray for tuberculosis at the Entry visit.

• 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).

Please refer to this study by ClinicalTrials.gov identifier  NCT00160641

UCB- Clinical Trial Call Center      +1 877 822 9493 

Bulgaria
      Sofia,  Bulgaria
      Pleven,  Bulgaria
      Sofia,  Bulgaria
      Sofia,  Bulgaria
      Stara Zagora,  Bulgaria
Croatia
      Rijeka,  Croatia
Czech Republic
      Ostrava-Poruba,  Czech Republic
      Brno,  Czech Republic
      Praha 5,  Czech Republic
      Zlin,  Czech Republic
      Praha-2,  Czech Republic
      Uherske Hradiste,  Czech Republic
      Hlucin,  Czech Republic
      Sokolov,  Czech Republic

Study chairs or principal investigators

Jeffrey White, MD White, MD,  Study Director,  UCB Pharma, Inc.   

Study ID Numbers:  C87051; EudraCT Number: 2005-002629-30
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00160641
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Bulgaria: Bulgarian Drug Agency; Chile: Instituto de Salud Publica de Chile; Croatia: Ministry of Health and Social Care; Czech Republic: State Institute for Drug Control; Estonia: The State Agency of Medicine; Israel: Israeli Health Ministry Pharmaceutical Administration; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health; Mexico: National Institute of Public Health, Health Secretariat; Poland: Ministry of Health; Russia: Pharmacological Committee, Ministry of Health; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Slovakia: State Institute for Drug Control; Ukraine: State Pharmacological Center - Ministry of Health; United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13