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

NCT01487551 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2014-08-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

paquinimod

Hard gelatine capsules 3.0 mg/day for 8 weeks

Sponsors & Collaborators

  • Active Biotech AB

    lead INDUSTRY

Principal Investigators

  • Roger Hesselstrand, MD · Dept of Rheumatology, University Hospital in Lund, Sweden

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • Germany
  • Sweden
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01487551 on ClinicalTrials.gov