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Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)

2017-09-06 22:23:21 | BioPortfolio

Summary

This study will evaluate tofacitinib treatment in subjects with diffuse cutaneous systemic scleroderma (dcSSc) in a placebo controlled trial. This phase I/II study is intended to provide safety, and tolerability data in participants with dcSSc when dosed to target exposures similar to that used in adult participants with RA.

Description

The purpose of this clinical research study is to evaluate the safety, tolerability and efficacy of treatment with tofacitinib (study drug) versus placebo (a substance with no active ingredients and therefore may have no treatment benefit) in people with diffuse cutaneous systemic scleroderma. Subjects will be randomized to tofacitinib vs. placebo in a 2:1 ratio at 5 mg twice a day for 24 weeks. Subjects will then be offered to participate in an open label phase during which they will receive tofacitinib 5 mg twice a day for 24 weeks.

Study Design

Conditions

Systemic Sclerosis

Intervention

Tofacitinib, Placebo Oral Tablet

Location

University of Pittsburgh
Pittsburgh
Pennsylvania
United States
15261

Status

Not yet recruiting

Source

University of Michigan

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-09-06T22:23:21-0400

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