An Open-Label Study to Evaluate Biomarkers and Safety in Systemic Sclerosis Patients Treated With ABR-215757 (Paquinimod)
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|ClinicalTrials.gov Identifier: NCT01487551|
Recruitment Status : Completed
First Posted : December 7, 2011
Last Update Posted : August 27, 2014
The primary objective is to study changes in disease related biomarkers in patients with progressive SSc during treatment with ABR-215757.
The secondary objectives are to assess the safety and tolerability of ABR-215757,to assess disease activity and quality of life (QoL)during treatment with ABR-215757 and to assess the plasma levels of ABR-215757 during the study.
|Condition or disease||Intervention/treatment||Phase|
|Systemic Sclerosis||Drug: paquinimod||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Study to Evaluate Biomarkers and Safety in Systemic Sclerosis Patients Treated With ABR-215757 (Paquinimod)|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Hard gelatine capsules 3.0 mg/day for 8 weeks
- Biomarkers [ Time Frame: Assessment of biomarkers will be performed at baseline, after 2, 4, and 8 weeks of treatment. ]Changes in SSc disease activity related biomarkers
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): NCT01487551
|Principal Investigator:||Roger Hesselstrand, MD||Dept of Rheumatology, University Hospital in Lund, Sweden|