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|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487551
|Principal Investigator:||Roger Hesselstrand, MD||Dept of Rheumatology, University Hospital in Lund, Sweden|