Abatacept Treatment in Polymyositis and Dermatomyositis (ARTEMIS)
Recruitment status was Recruiting
The purpose of this study is to investigate the clinical efficacy of abatacept on disease activity in polymyositis, and dermatomyositis patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Abatacept Treatment in Polymyositis and Dermatomyositis|
- The number of responders, defined as improved according the IMACS criteria [ Time Frame: 6 months ] [ Designated as safety issue: No ]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%.
- The change in the individual components of the IMACS core set measures for disease activity [ Time Frame: at 3 and 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
abatacept will be given as intravenous infusions at time 0 then after, 2, 4, 8, 12, 16 and 20 weeks.Drug: Abatacept
Subjects will be treated with abatacept for 6 months and receive a total of up to 7 doses (intravenous infusions) the infusions will be given with the following intervals: at time 0 then after, 2, 4, 8, 12, 16 and 20 weeks.
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.
|Contact: Ingrid E Lundberg, MD, PhD||+46851770000 ext 6087||Ingrid.Lundberg@ki.se|
|Contact: Maryam Dastmalchi, MD; PhD||+46851770000 ext 1915||Maryam.Dastmalchi@karolinska.se|
|Institute of Rheumatology||Not yet recruiting|
|Prague, Czech Republic, 12850|
|Contact: Jiri Vencovsky, MD, PhD +420224914469 firstname.lastname@example.org|
|Contact: Herman Mann, MD email@example.com|
|Principal Investigator: Jiri Vencovsky, MD;PhD|
|Sub-Investigator: Herman Mann, MD|
|Karolinska University Hospital||Recruiting|
|Stockholm, Sweden, 17176|
|Contact: Ingrid E Lundberg, MD, PhD +46851770000 ext 6087 Ingrid.Lundberg@ki.se|
|Contact: Maryam Dastmalchi, MD, PhD +46851770000 ext 1915 Maryam.Dastmalchi@karolinska.se|
|Principal Investigator: Ingrid E Lundberg, MD,PhD|
|Sub-Investigator: Maryam Dastmalchi, MD,PhD|