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An Open-Label Study to Evaluate Biomarkers and Safety in Systemic Sclerosis Patients Treated With ABR-215757 (Paquinimod)

Systemic Sclerosis Clinical Trial

Official title:
An Open-Label Study to Evaluate Biomarkers and Safety in Systemic Sclerosis Patients Treated With ABR-215757 (Paquinimod)

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01487551
Study type Interventional
Source Active Biotech AB
Contact
Status Completed
Phase Phase 2
Start date December 2011
Completion date February 2013
View Details
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