Abatacept Treatment in Polymyositis and Dermatomyositis (ARTEMIS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01315938|
Recruitment Status : Unknown
Verified February 2010 by Karolinska Institutet.
Recruitment status was: Recruiting
First Posted : March 16, 2011
Last Update Posted : March 16, 2011
|Condition or disease||Intervention/treatment||Phase|
|Polymyositis Dermatomyositis||Drug: Abatacept||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Abatacept Treatment in Polymyositis and Dermatomyositis|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||June 2013|
abatacept will be given as intravenous infusions at time 0 then after, 2, 4, 8, 12, 16 and 20 weeks.
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.
- 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%.
- The change in the individual components of the IMACS core set measures for disease activity [ Time Frame: at 3 and 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01315938
|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|