A 24 week study in which patients are given study medication 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 compare the efficacy of two dose regimens of liquid formulation certolizumab pegol in combination with MTX to MTX alone in treating the signs and symptoms of patients with active rheumatoid arthritis measured by the ACR20 at week 24.
Secondary Outcomes: To assess two dose regimens of certolizumab pegol in combination with MTX and MTX alone in:; • The safety and tolerability of certolizumab pegol in patients with active RA.; • The prevention of joint damage in patients with active RA.; • Health Outcomes Measures in patients with active RA.; • Improving physical function in patients with active RA.; To characterize the pharmacokinetic profile and immunogenicity of two dose regimens of liquid formulation certolizumab pegol in combination with methotrexate.
Expected Total Enrollment:  590

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

Criteria

Inclusion Criteria:

• 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: ≥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after randomization even if they are no longer receiving study treatment in the present study, provided they have not withdrawn their informed consent.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 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).

Please refer to this study by ClinicalTrials.gov identifier  NCT00160602

UCB- Clinical Trial Call Center      +1 877 822 9493 

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

Study chairs or principal investigators

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

Study ID Numbers:  C87050; EudraCT Number: 2005-002326-63
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00160602
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