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Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc) — TOFA-SSc  

Systemic Sclerosis Clinical Trial

Official title:
Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Phase I/II Two Center Safety and Tolerability Study

Clinical Trial Summary

This Phase I/II placebo controlled trial will evaluate tofacitinib in subjects with diffuse cutaneous systemic scleroderma (dcSSc). This trial 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 rheumatoid arthritis.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03274076
Study type Interventional
Source University of Michigan
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 25, 2017
Completion date November 15, 2019
View Details
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