At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 15 enrolled
Drug / intervention
Tofacitinib +1 moredrug
Likely dose
Tofacitinib 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Phase I/II Two Center Safety and Tolerability Study
In Brief
A Phase 2 clinical trial evaluating Tofacitinib and Placebo Oral Tablet for Systemic Sclerosis and Scleroderma. Completed, enrolled 15 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Sclerosis, Scleroderma
CountriesUnited States
CollaboratorsPfizer
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedSep 2017
Enrollment StartSep 2017
Primary CompletionApr 2019
Study CompletionNov 2019
TodayJul 2026
First PostedSep 6, 2017
Enrollment StartSep 25, 2017
Primary CompletionApr 8, 2019
Study CompletionNov 15, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.8 years ago
Interventions
Tofacitinibdrug
Oral medication tofacitinib 5 mg twice a day for 24 weeks.
Placebo Oral Tabletdrug
Oral Placebo 5 mg twice a day for 24 weeks