Dr. Matthew Baker at Stanford University is leading a new study, assessment of sarilumab in patients with glucocorticoid-dependent sarcoidosis
The purpose of this research study is to demonstrate that sarilumab is an effective treatment for bringing about and maintaining glucocorticoid-free remission in male and female patients ages 18-75 with active biopsy proven glucocorticoid-dependent sarcoidosis.
Prior to participation in this study, patients will go through a screening period. The screening period is a time in which researchers can prepare patients for the study and check/test patients for inclusion and exclusion criteria.
Fifteen (15) eligible patients will be selected for participation in this study at Stanford University.
General Inclusion Criteria are:
- Adults 18 or older
- Diagnosed with sarcoidosis through a positive biopsy
- Involvement of the lungs (stage II or III pulmonary sarcoidosis), lymph nodes, liver, kidneys, spleen, bone, soft tissues, skin, and/or eyes.
- At least one active manifestation, defined by the need for ongoing glucocorticoid treatment to control a sign or symptom of sarcoidosis, which requires treatment with prednisone (or equivalent corticosteroid) ≥ 10 mg and ≤ 60 mg daily (i.e. glucocorticoid dependence), with stable dosing for ≥ 28 days prior to baseline. If patients are taking a glucocorticoid other than prednisone, they will be changed to prednisone at the equivalent dose and take this daily for ≥ 14 days prior to baseline.
- DMARDs including methotrexate, leflunomide, azathioprine, mycophenolate mofetil, and/or anti-malarials (i.e. hydroxychloroquine) will be permitted, but the regimen must be stable for ≥ 28 days prior to baseline and remain stable during follow-up.
- Ability to understand and the willingness to sign a written informed consent document.
General Exclusion Criteria are:
- Patients with stage IV pulmonary sarcoidosis, central nervous system sarcoidosis, or cardiac sarcoidosis.
- Prior treatment with an anti-IL-6 therapy.
- Treatment with a biologic agent including rituximab, belimumab, TNF inhibitors, abatacept, or IL-17 inhibitors administered within 28 days prior to baseline (6 months for rituximab).
- Treatment with cyclophosphamide within 3 months prior to baseline.
- Treatment with prednisone < 10 mg or > 60 mg daily.
- Known hypersensitivity or allergy to the study drug.
- History of, or current, inflammatory or autoimmune disease other than sarcoidosis which would present a safety issue or confound interpretation of the data.
- Patients currently pregnant or breast-feeding.
- Administration of a live/attenuated vaccine within 30 days.
- Evidence of active tuberculosis, HIV, or hepatitis B or C infection.
- History of cancer other than non-melanoma skin cancer.
- Participation in any clinical research study evaluating another investigational drug or therapy.
- Any patient who has had surgery within 4 weeks prior to the screening visit or with planned surgery during the course of the study.
THOSE THAT QUALIFY MAY:
- Receive study related care from a Stanford rheumatologist at no cost
- Receive compensation for time and travel
- Have access to a medication being investigated for the treatment of sarcoidosis
LEARN MORE TODAY!
Please contact Dr. Matthew Baker at firstname.lastname@example.org
For participant’s rights questions, contact 1-866-680-2906