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

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT03793439
Phase
PHASE1
Status
Completed

Conditions

  • Sarcoidosis
  • Sarcoidosis Lung
  • Sarcoidosis, Pulmonary

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib 5mg Oral Tablet [Xeljanz] 16 week trial — DRUG
    Tofacitinib 5mg oral table twice daily for 16 weeks
  • Spirometry — DIAGNOSTIC_TEST
    Spirometry testing at baseline, week 4, week 8, week 12, and week 16
  • RNA Sequencing — GENETIC
    RNA sequencing test at baseline and week 16
  • Laboratory testing — DIAGNOSTIC_TEST
    Laboratory testing at baseline and weeks 2, 4, 8, 12 and 16
  • Corticosteroid — DRUG
    Taper corticosteroids starting at week 4
  • Tofacitinib 5mg [Xeljanz] 1 year open-label extension — DRUG
    After 16 weeks, subjects who meet the primary end-point will be permitted an optional one year open-label extension.

Study Details

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.

Key Dates

First listed
Jan 4, 2019
Start date
May 15, 2019
Status verified
Dec 2021
Primary completion
Jun 24, 2020
Completion
Jun 24, 2021

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open-label treatment
    All subjects will receive tofacitinib 5mg twice daily from week 0 to week 16, and a corticosteroid taper starting at week 16. Participants also undergo spirometry, RNA sequence testing, and laboratory evaluations.

Primary Outcome Measure

Number of Participants With 50% Reduction in Corticosteroid Requirement [ Time Frame: 16 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health & Science UniversityPortlandOregon97239-

Find similar trials in Portland, OR

By research site
Oregon Health & Science University· Portland, OR

Related Studies