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New Study Demonstrates ACTEMRA(R) (tocilizumab) Inhibits Progression of Joint Damage in Rheumatoid Arthritis Patients
Date:5/9/2008

Phase III trial for ACTEMRA across multiple patient populations, it is an exciting day for RA patients, the science of RA and for Roche."

About the LITHE Trial

The LITHE trial is a three-arm, randomized, double-blind, placebo- controlled study designed to evaluate the safety and efficacy of ACTEMRA (4 mg/kg or 8 mg/kg) combined with methotrexate compared to placebo with methotrexate in RA patients. Patients received either ACTEMRA intravenously every four weeks plus methotrexate weekly or placebo infusions every four weeks plus methotrexate weekly.

The study analyzed patients' response to treatment by measuring structural damage in the joints through X-rays; disease activity was measured through standard assessments such as the ACR score(1), developed by the American College of Rheumatology (ACR). The study also examined improvement in physical function through the Health Assessment Questionnaire (HAQ).

The LITHE trial is one of five Phase III clinical studies designed to evaluate ACTEMRA as a potential new treatment for RA across multiple patient populations. Four of the Phase III trials - OPTION, TOWARD, RADIATE and AMBITION - are completed and have reported meeting their primary study endpoints. Data from all four trials will be presented at the upcoming European Congress of Rheumatology (ECR) held by the European League Against Rheumatism (EULAR) in Paris (June 11-14).

About ACTEMRA(TM) (tocilizumab)

ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. Studies suggest that reducing the activity of IL-6, one of several key cytokines involved in the inflammatory process, may reduce inflammation of the joints and relieve certain systemic effects of RA. The extensive clinical development program conducted by Roche includes five clinical studies and has enrolled more than 4,000 patients in 40 countries, including the United States. Four studies are completed and have reported meeting th
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