Immunex启动大型 Enbrel 试验(上)
NEW YORK (Reuters Health) - Immunex Corp. and Wyeth-Ayerst Laboratories, a division of American Home Products Corp., plan to launch a 10,000-patient trial this fall that will study rheumatoid arthritis (RA) treatment, while also measuring the effectiveness of Immunex's Enbrel (etanercept) against other anti-rheumatic drugs.
Immunex spokeswoman Robin Shapiro said that the RADIUS (Rheumatoid Arthritis Intervention and Utilization Study) study would provide "additional insight into the rheumatoid arthritis population in which the epidemiology [of the disease] is lacking."
The two-part study will gather information and build a database on RA treatment practice patterns. It also will assess the tolerability of RA therapies and the efficacy of disease modifying anti-rheumatic drugs (DMARDs) and biologic response modifiers, including Johnson & Johnson's Remicade (infliximab). Remicade, though indicated only in combination therapy to RA patients, is Enbrel's biggest competitor in the market.
In the first part of the trial, RADIUS 1, to begin in the next 45 days, investigators will enroll 5,000 adult patients who meet an established criterion for RA diagnosis and currently require a new DMARD for therapy. This DMARD can be a change from, or an addition to, current treatment regimen. However, the primary focus will be on recruiting patients not currently on Enbrel. About 600 investigators will recruit patients from medical centers around the country. The patients will be followed for 2 years.
In the second part of the study, RADIUS 2 will recruit another 5,000 patients to begin new treatment with Enbrel. The patients in RADIUS 2 must meet the same criteria as for RADIUS 1 and will be recruited by the same 600 investigators., http://www.100md.com
Immunex spokeswoman Robin Shapiro said that the RADIUS (Rheumatoid Arthritis Intervention and Utilization Study) study would provide "additional insight into the rheumatoid arthritis population in which the epidemiology [of the disease] is lacking."
The two-part study will gather information and build a database on RA treatment practice patterns. It also will assess the tolerability of RA therapies and the efficacy of disease modifying anti-rheumatic drugs (DMARDs) and biologic response modifiers, including Johnson & Johnson's Remicade (infliximab). Remicade, though indicated only in combination therapy to RA patients, is Enbrel's biggest competitor in the market.
In the first part of the trial, RADIUS 1, to begin in the next 45 days, investigators will enroll 5,000 adult patients who meet an established criterion for RA diagnosis and currently require a new DMARD for therapy. This DMARD can be a change from, or an addition to, current treatment regimen. However, the primary focus will be on recruiting patients not currently on Enbrel. About 600 investigators will recruit patients from medical centers around the country. The patients will be followed for 2 years.
In the second part of the study, RADIUS 2 will recruit another 5,000 patients to begin new treatment with Enbrel. The patients in RADIUS 2 must meet the same criteria as for RADIUS 1 and will be recruited by the same 600 investigators., http://www.100md.com