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

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

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