In This SectionTexas Health Research & Education Institute
Clinical Trials
Disease or Condition
Rheumatoid Arthritis
Title
A Study to Evaluate the Safety and Efficacy of Certolizumab Pegol for the Treatment of Patients with Active Rheumatoid Arthritis
Description
Patients will receive certolizumab or placebo for 12 weeks. After 12 weeks, all patients will receive treatment with open-label CZP for a minimum of 16 additional weeks.
IRB Number
Pro466
Inclusion/Notes
INCLUSION:
Patients must be able to understand the information provided to them and to give written infomed consent.
Female patients must be either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide).
Patients must have active Rheumatoid Arthritis (RA) disease as defined by:
• =5 tender joints (28 joint count) at Screening and Baseline; and
• =4 swollen joints (28 joint count) at Screening and Baseline; and
• =10 mg/L CRP and/or =28mm/hour ESR (Westergren) at screening
Patients must have had an unsatisfactory response or intolerance to at least one traditional DMARD.
Patients must be able and willing to comply with the requirements of the study protocol.
EXCLUSION:
Patients have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis).
Patients have >3 arthroplasties due to RA and/or Steinbrocker IV functional capacity.
Patients have a secondary, non–inflammatory type of arthritis (e.g., osteoarthritis or fibromyalgia) that in the Investigator’s opinion is symptomatic enough to interfere with evaluation of the effect of study drug on the patient’s primary diagnosis of RA.
Patients with concurrent acute or chronic viral hepatitis B or C.
Patients with known human immunodeficiency virus (HIV) infection.
Patients with active tuberculosis (TB) or a history of active (TB),
Female patients who are breast-feeding, pregnant, or plan to become pregnant during the study or within twelve weeks following last dose of study drug.
