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NCT03274076 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)
A Phase 1 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT03274076: Completed Phase 1 study, sponsored by University of Michigan.
NCT03274076 is a Phase 1 study that has completed, run by University of Michigan. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03274076, a Phase 1 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study 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.
Primary Outcome
Primary outcome is met if any participants experience a grade 3 or higher event prior to Week 24. A grade 3 AE would constitute as "severe". Grading was following using CTCAE v 4.03. Note that the planned statistical analysis (Fisher's exact test) could not be performed because there were no events.
Interventions
- DRUG Tofacitinib
- DRUG Placebo Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2017-09-25 |
| Est. Completion | 2019-11-15 |
| Phase | Phase 1 |
What the finished NCT03274076 record still lists
NCT03274076 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Tofacitinib is the first listed.
NCT03274076 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03274076 about?
NCT03274076 is a clinical study titled "Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)". 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 wit...
What is the current status of trial NCT03274076?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2017-09-25. Estimated completion is 2019-11-15.
What interventions are being tested in trial NCT03274076?
The interventions under investigation include: Tofacitinib (DRUG), Placebo Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT03274076?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03274076's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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