Clinical trial: Open-label Trial of Tofacitinib in Cutaneous Sarcoidosis and Granuloma Annulare (NCT03910543)

Eligibility criteria:
Inclusion Criteria:

          -  18 years old or older

          -  Diagnosis of cutaneous sarcoidosis or granuloma annulare with supportive skin biopsies
             in which other causes of granulomas (infectious, foreign body) have been ruled out

          -  Patients with either: Cutaneous Sarcoidosis Activity and Morphology (CSAMI) activity
             score greater than or equal to 10 (patients with a CSAMI greater than or equal to 10
             have active cutaneous sarcoidosis involving several distinct cutaneous sites and would
             otherwise be considered candidates for systemic therapy), or any CSAMI score and
             sarcoidosis involvement causing functional impairment (i.e. nasal or visual field
             obstruction).

          -  For patients with granuloma annulare, patients with 5% or greater Body Surface Area
             (BSA) will be enrolled.

          -  If patients are on other systemic therapies for their sarcoidosis or granuloma
             annulare, they must be taking a stable dose of the other medication(s) for at least 3
             months with no plans to change the regimen in the next 6 months. With the exception of
             methotrexate and/or low dose prednisone, use of concomitant immunosuppressants, e.g.
             infliximab, azathioprine, etc., will not be permitted.

          -  Females of childbearing potential must agree to use birth control during the study and
             there must be a negative pregnancy test documented prior to starting the medication.

          -  Patients must be willing to undergo skin biopsies, blood collection, and total body
             photography and comply with clinic visits

        Exclusion Criteria:

          -  Age <18 years old

          -  Patients with a history of malignancy (except history of successfully treated basal
             cell or squamous cell carcinoma of the skin)

          -  Patients known to be HIV or hepatitis B (HBV) or C (HCV) positive (prior exposure to
             but clearance of HBV and HCV is acceptable for study entry as long as patient is being
             monitored by hepatology)

          -  Patients with active tuberculosis or untreated latent tuberculosis as determined by
             positive tuberculin skin test or positive QuantiFERON® Tuberculosis (TB) test and, as
             necessary, chest X-ray

          -  Patients with significant hepatic impairment

          -  Patients with untreated peptic ulcer disease

          -  Patients taking immunosuppressive medications, with the exception of methotrexate
             and/or low- dose prednisone, including but not limited to mycophenolate mofetil,
             azathioprine, tacrolimus, cyclosporine, or Tumor Necrosis Factor (TNF-α) inhibitors

          -  Women of childbearing potential who are unable or unwilling to use birth control while
             taking the medication

          -  Women who are pregnant or nursing. If a woman becomes pregnant during the study, she
             will stop study medication and be removed from the study. She will be urged to follow
             up with her Primary Care Physician or OB/GYN. The study doctors will ask to follow the
             pregnancy to its outcome.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs.  She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications.  On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli.

Patient description (patient's own words): I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB.

Does the patient match the trial criteria? Entailment