An Open-Label Study to Evaluate Biomarkers and Safety in Systemic Sclerosis Patients Treated With ABR-215757 (Paquinimod)
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.
|Study Design:||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Study to Evaluate Biomarkers and Safety in Systemic Sclerosis Patients Treated With ABR-215757 (Paquinimod)|
- Biomarkers [ Time Frame: Assessment of biomarkers will be performed at baseline, after 2, 4, and 8 weeks of treatment. ] [ Designated as safety issue: No ]Changes in SSc disease activity related biomarkers
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Hard gelatine capsules 3.0 mg/day for 8 weeks
Other Name: paquinimod
This is an open label single arm Phase II study in patients with progressive SSc. Patients will be treated with ABR-215757 for 8 weeks. Assessment of biomarkers, disease activity and safety parameters will be performed during treatment. Patients will be offered to continue in an open label extension.
|Contact: Thore Nederman, Ph.Demail@example.com|
|Principal Investigator:||Roger Hesselstrand, MD||Dept of Rheumatology, University Hospital in Lund, Sweden|