CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 5 enrolled
Drug / intervention
Tofacitinib 5mg Oral Tablet [Xeljanz] 16 week trial +5 moredrug
Likely dose
Tofacitinib 5mg Oral Tablet [Xeljanz] 16 week trialfrom 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.

Search/NCT03793439
NCT03793439Phase 1Completed

Tofacitinib Hypothesis-generating, Pilot Study for Corticosteroid-Dependent Sarcoidosis

Oregon Health and Science University·interventional·Posted Jan 4, 2019·Updated Feb 18, 2022

In Brief

A Phase 1 clinical trial evaluating Tofacitinib 5mg Oral Tablet [Xeljanz] 16 week trial, Spirometry, and 4 other interventions for Sarcoidosis, Pulmonary and 2 related conditions. Completed, enrolled 5 participants across 1 site.

Detailed Summary

This is a pilot study to determine whether further research is warranted to assess whether tofacitinib is an effective steroid sparing treatment for pulmonary sarcoidosis. The primary endpoint for this study is a 50% or greater reduction in corticosteroid requirement.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJan 4, 2019
Enrollment StartMay 15, 2019
Primary CompletionJun 24, 2020
Study CompletionJun 24, 2021
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 7.5 years ago

Interventions

Tofacitinib 5mg Oral Tablet [Xeljanz] 16 week trialdrug

Tofacitinib 5mg oral table twice daily for 16 weeks

Spirometryother

Spirometry testing at baseline, week 4, week 8, week 12, and week 16

RNA Sequencinggenetic

RNA sequencing test at baseline and week 16

Laboratory testingother

Laboratory testing at baseline and weeks 2, 4, 8, 12 and 16

Corticosteroiddrug

Taper corticosteroids starting at week 4

Tofacitinib 5mg [Xeljanz] 1 year open-label extensiondrug

After 16 weeks, subjects who meet the primary end-point will be permitted an optional one year open-label extension.