A phase IIIb, multicenter 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 - Realistic

CB Pharma SA0 个研究点目标入组 1,048 人开始时间: 2009年3月11日最近更新: 2012年4月24日

适应症

试验速览

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•1. Patients must be at least 18 years old at the screening visit. 2. Patients must be able to understand the information provided to them and to give written Informed Consent. 3. 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). Abstinence only is not an acceptable method. Patients must agree to use adequate contraception during the study and for 12 weeks after their last dose of CZP. Male patients must agree to ensure they or their female partner(s) uses adequate contraception during the study and for 12 weeks after the patient receives their last dose of CZP. 4. Patients must have a diagnosis of adult?onset RA of at least three months duration as defined by the 1987 ACR classification criteria.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Patients have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis). 2. Patients have >3 arthroplasties due to RA and/or Steinbrocker IV functional capacity. 3. 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. 4. Patients have a history of an infected joint prosthesis at any time with that prosthesis still in situ. 5. Patients have received any experimental non?biological therapy, within or outside of a clinical study in the past 3 months or within 5 half-lives prior to Baseline visit (whichever is longer). 6. Patients have received any experimental biological agent within or outside of a clinical study in the past three months or within 5 half-lives prior to Baseline (whichever is longer).

发起方

CB Pharma SA