The Oregon Health and Science University is leading a new clinical trial, Tofacitinib for Prednisone Dependent Pulmonary Sarcoidosis Patients.
The purpose of this study is to learn more about treatment of sarcoidosis in patients who currently require corticosteroids. The investigators of this study are assessing the treatment potential of tofacitinib for patients. Tofacitinib is FDA approved for the treatment of rheumatoid arthritis and psoriatic arthritis. However, it’s effectiveness is not yet known in sarcoidosis.
Participants in this trial will receive tofacitinib at no cost for 16 weeks with the option of continuing treatment for an additional year.
Participation requires 7 total office visits in Portland, OR. Office visits will include: a physical exam, blood draws, pulmonary function testing, and imaging.
Compensation includes $50 per visit.
General Inclusion Criteria are:
- Participants age 18 and older
- Diagnosis of pulmonary sarcoidosis
- On a stable dose of prednisone of 15-30 mg for at least 4 weeks
- Participants may be taking methotrexate, but may not be taking other immunosuppressive or immunomodulatory treatments
General Exclusion Criteria are:
- Participants taking immunomodulatory medications other than methotrexate in the two months prior to the study period will not be included. This includes but is not limited to azathioprine, cyclophosphamide, leflunomide, mycophenolate mofetil, cyclosporine, tacrolimus, and biologic medications
- 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
- 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 current signs and symptoms of systemic lupus erythematosus, or severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, or cerebral diseases (with the exception of sarcoidosis).
Interested patients can contact:
Kimberly Ogle
(503) 494-5711 (message phone only)
oglki@ohsu.edu