Clinical Trial: Abatacept Treatment in Polymyositis and Dermatomyositis

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Abatacept Treatment in Polymyositis and Dermatomyositis

Brief Summary: The purpose of this study is to investigate the clinical efficacy of abatacept on disease activity in polymyositis, and dermatomyositis patients.

Detailed Summary: Patients with polymyositis or dermatomyositis who have persisting signs of inflammatory active disease after treatment with glucocorticoids and at least one immunomodulating drug (e.g. methotrexate or azathioprine) for a minimum of 3 months.
Sponsor: Karolinska Institutet

Current Primary Outcome: The number of responders, defined as improved according the IMACS criteria [ Time Frame: 6 months ]

The definition of improvement is based on a core set of clinical and laboratory variables to assess disease activity and outcome measure developed in an international consensus, partly validated and recommended for use in clinical trials by the IMACS group (26http://www.niehs.nih.gov/research/resources/collab/imacs). The improvement is defined as any 3 of 6 core set measures improved ≥ 20% with no more than 2 (not including MMT) worse by ≥ 25%.


Original Primary Outcome: Same as current

Current Secondary Outcome: The change in the individual components of the IMACS core set measures for disease activity [ Time Frame: at 3 and 6 months ]

Original Secondary Outcome: Same as current

Information By: Karolinska Institutet

Dates:
Date Received: March 15, 2011
Date Started: January 2011
Date Completion: June 2013
Last Updated: March 15, 2011
Last Verified: February 2010