Clinical Pharmacology Research Program

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Download - Review of Systemic Lupus

UCB - C87094

PROTOCOL: A phase IIIB, multi-centre study with a 12 week double-blind, placebo-controlled, randomized period, followed by an open-label extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis.

PURPOSE AND BACKGROUND

This study is investigating the drug certolizumab pegol; this drug works by blocking an inflammatory substance in the body called tumor necrosis factor (TNF). Certolizumab pegol is currently approved for treatment of Crohn’s disease (a chronic disease of the intestines).

WHAT DOES THIS STUDY INVOLVE?

Each visit will be approximately 1 – 2 hrs; blood work, questionnaires, joint assessments, injection, and vital signs are done at each visit. The screening visit will also include a physical exam, EKG, tuberculin skin test and chest x-ray. The medication is a subcutaneous injection given twice a month for a treatment period of 12 weeks. An extension phase from week 12 until the drug is commercially available for RA will be available to study participants.

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