A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study

Celltech R&D Ltd0 个研究点目标入组 950 人开始时间: 2005年2月28日最近更新: 2012年10月9日

适应症

试验速览

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•A diagnosis of adult-onset RA (of at least six months duration but not longer then 15 years prior to Screening) as defined by the 1987 American College of Rheumatology classification criteria.
•Active RA disease at Screening and Baseline as defined as =9 tenderjoints, =9 swollen joints and fulfilling one of the following two criteria, namely, =30mm/hour ESR (Westergren) or CRP> 15 mg/L.
•Must have received a stable dose of methotrexate with or without folic acid for at least 3 months prior to Baseline visit. The minimum dose is 10 mg methotrexate weekly. No other DMARD is permitted.
•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

•A diagnosis of any other inflammatory arthritis e.g. psoriatic arthritis or ankylosing spondylitis.
•A secondary, non-inflammatory type arthritis (e.g. OA or fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of CDP870 on the patient's primary diagnosis of RA.
•Does not meet any of the concomitant medication criteria (see protocol, section 3.3.2).
•A history of chronic infection, recent serious or life-threatening infection (within 6 months, including herpes zoster), or any current sign or symptom that my indicate an infection (e.g. fever, cough).
•A history of tuberculosis or positive chest X-ray for tuberculosis or positive (defined as positive induration per local medical practice) PPD skin test. Patients with a positive PPD skin test who have received a BCG vaccination and have a negative chest X-ray for tuberculosis (TB) may be enrolled.
•A history of an adverse reaction to PEG or a protein medicinal product.

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