Tofacitinib Hypothesis-generating, Pilot Study for Corticosteroid-Dependent Sarcoidosis
NCT03793439
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- Meet World Association of Sarcoidosis and other Granulomatous Disorders (WASOG) definition of pulmonary sarcoid
- Histologically proven sarcoid
- Evidence of pulmonary sarcoid on chest radiograph
- FVC 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.
- 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).
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Descriptive Information | |||||||||
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Brief Title ICMJE | Tofacitinib Hypothesis-generating, Pilot Study for Corticosteroid-Dependent Sarcoidosis | ||||||||
Official Title ICMJE | Tofacitinib Hypothesis-generating, Pilot Study for Corticosteroid-Dependent Sarcoidosis | ||||||||
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 this study is a 50% or greater reduction in corticosteroid requirement. | ||||||||
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 a significant decrease in pulmonary function testing, and with a similar quality of life as measured by a validated questionnaire (1). Objective 2: Test the hypothesis that the addition of tofacitinib will result in significantly decreased expression of signal transducer and activator of transcription (STAT)-1 dependent gene expression. Outline: This is a 16-week open-label, interventional, proof of concept, hypothesis-generating study. All subjects will receive Tofacitinib 5mg twice daily for 16 weeks. After four weeks on Tofacitinib, the corticosteroid will be tapered per a pre-defined protocol; once a reduction of 50% has been achieved, any further taper will be per physician discretion. After 16 weeks, subjects who meet the primary end-point will be permitted an optional one year open-label extension. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 | ||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Intervention Model Description: Open-label, interventional, proof of concept, hypothesis-generating study Masking: None (Open Label)Primary Purpose: Treatment | ||||||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Rosenbaum JT, Choi D, Wilson DJ, Grossniklaus HE, Harrington CA, Sibley CH, Dailey RA, Ng JD, Steele EA, Czyz CN, Foster JA, Tse D, Alabiad C, Dubovy S, Parekh P, Harris GJ, Kazim M, Patel P, White V, Dolman P, Korn BS, Kikkawa D, Edward DP, Alkatan H, Al-Hussain H, Yeatts RP, Selva D, Stauffer P, Planck SR. Parallel Gene Expression Changes in Sarcoidosis Involving the Lacrimal Gland, Orbital Tissue, or Blood. JAMA Ophthalmol. 2015 Jul;133(7):770-7. doi: 10.1001/jamaophthalmol.2015.0726. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 5 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | March 1, 2022 | ||||||||
Estimated Primary Completion Date | March 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 89 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03793439 | ||||||||
Other Study ID Numbers ICMJE | STUDY00017902 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Jim Rosenbaum, Oregon Health and Science University | ||||||||
Study Sponsor ICMJE | Oregon Health and Science University | ||||||||
Collaborators ICMJE | Pfizer | ||||||||
Investigators ICMJE |
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PRS Account | Oregon Health and Science University | ||||||||
Verification Date | August 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |