Status:
COMPLETED
Tofacitinib Hypothesis-generating, Pilot Study for Corticosteroid-Dependent Sarcoidosis
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Pfizer
Conditions:
Sarcoidosis, Pulmonary
Sarcoidosis Lung
Eligibility:
All Genders
18-89 years
Phase:
PHASE1
Brief 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 thi...
Detailed Description
Primary Objectives: Objective 1: Test the hypothesis that the addition of tofacitinib will allow patients with sarcoidosis to have 50% or greater reduction in their corticosteroid requirement without...
Eligibility Criteria
Inclusion
- Meet World Association of Sarcoidosis and other Granulomatous Disorders (WASOG) definition of pulmonary sarcoid
- Histologically proven sarcoid
- Evidence of pulmonary sarcoid on chest radiograph
- Forced vital capacity of \> 50%
- Require 15-30mg/day of prednisone or equivalent corticosteroid to control sarcoidosis.
- Stable dose of prednisone or equivalent corticosteroid for 4 weeks prior to enrollment.
Exclusion
- May be taking methotrexate but not other immunosuppressive or immunomodulatory treatments in the two months prior to study period. This includes but is not limited to azathioprine, cyclophosphamide, leflunomide, mycophenolate mofetil, cyclosporine, tacrolimus, and biologic medications.
- Patients requiring \>30mg/day prednisone or equivalent.
- Pregnant or lactating women.
- Hemoglobin \< 9g/dL or hematocrit \< 30%
- White blood cell count \<3.0 K/cu mm
- Absolute neutrophil count \<1.2 K/cu mm
- Platelet count \<100 K/cu mm
- Subjects with an estimated glomerular filtration rate (GFR) ≤40 ml/min
- Subjects with a total bilirubin, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) more than 1.5 times the upper limit of normal at screening.
- Severe, progressive, or uncontrolled chronic liver disease including fibrosis, cirrhosis, or recent or active hepatitis.
- History of any lymphoproliferative disorder such as Epstein Barr virus (EBV) related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggest of current lymphatic disease.
- Current malignancy or history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
- Have or have had an opportunistic infection (e.g., herpes zoster \[shingles\], cytomegalovirus, Pneumocystis carinii, aspergillosis and aspergilloma, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
- Have a known infection with human immunodeficiency virus (HIV)
- Have current signs and symptoms of systemic lupus erythematosus, or severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac (New York Heart Association class III or IV), neurologic, or cerebral diseases (with the exception of sarcoidosis).
Key Trial Info
Start Date :
May 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03793439
Start Date
May 15 2019
End Date
June 24 2021
Last Update
February 18 2022
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239