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CIMZIA(R) (Certolizumab Pegol) Provides Rapid and Sustained Relief from Signs and Symptoms of Rheumatoid Arthritis for Two Years
Date:10/27/2008

eeks O, 2 and 4, then CIMZIA 200 mg together with MTX every two weeks; 246 patients received CIMZIA 400 mg together with MTX every two weeks; 127 patients received placebo together with MTX every two weeks.

In all arms of the study, the dose of methotrexate was 10mg per week or greater. Patients were assessed for improvement in signs and symptoms of RA. The primary endpoint for the study RAPID 2 was ACR20 responder rate at week 24.

In both studies, CIMZIA given at a dosage of 200mg every two weeks produced similar clinical results as a dosage of 400mg every two weeks.

(a) ACR (American College of Rheumatology) response scores measure improvement in the tender and swollen joint count and also include assessment of the following five parameters: patient's global assessment, physician's global assessment, patient's assessment of pain, degree of disability, and level of acute-phase reactant. ACR20 is achieved when there is 20% improvement in the tender and swollen joint count as well as a 20% improvement in at least three of the five parameters. ACR50 & ACR70 are an extension of these criteria corresponding to a 50% and 70% improvement respectively. (1)

(b) Modified Total Sharp Scores (mTSS) is a measurement used to assess changes in bone erosion and joint-space narrowing measured by X-ray. A smaller change in mTSS reflects less progression of joint damage. (2)

Open-Label Study to RAPID 1 (028)

The Phase III, open-label extension (OLE) study to RAPID 1 is investigating the long-term efficacy and safety of subcutaneous CIMZIA (400 mg every 2 weeks) together with methotrexate in the treatment of signs and symptoms and in the prevention of joint damage in patients with active RA. Patients completing RAPID 1 through 52 weeks (completers), or who were ACR20 nonresponders at Week 12 (confirmed at Week 14) and were to be withdrawn from the study at Week 16 (withdrawers), could continue in the 028 study. The open-label extension study c
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