Clinical trial: Trial of Antimycobacterial Therapy in Sarcoidosis (NCT01074554)

Eligibility criteria:
Inclusion Criteria:

          1. Patients with sarcoidosis as defined by the ATS/ERS/WASOG statement on sarcoidosis as
             defined by the clinical presentation consistent with sarcoidosis, biopsy finding
             granulomas, and no alternative for the cause of the granulomas, such as tuberculosis

          2. Patients must have chronic cutaneous skin lesions with or without taking chronic
             therapy (corticosteroids, methotrexate (max 10mg/week), azathioprine,
             hydroxychloroquine, cyclophosphamide, minocycline, doxycycline and chloroquine), in
             which the dose has not been altered in the 2 months prior to starting the study.

          3. Subject has a diagnosis of cutaneous sarcoidosis for greater than 6 months with a
             Sarcoidosis Activity and Severity Index assessment score of at least 4. Diagnosis can
             be made by either:

               -  Skin lesions characteristic of sarcoidosis and a biopsy showing granulomas with
                  no evidence of mycobacteria, fungus, or malignancy.

               -  A biopsy that does not show granulomas, but the patient has characteristic skin
                  lesions and history of clinical features suggesting sarcoidosis (previous biopsy
                  revealing noncaseating granuloma, bilateral hilar adenopathy, erythema nodosum,
                  uveitis, raised ACE level, BAL lymphocytosis (CD4:CD8>3.5), panda/lambda sign on
                  gallium scan)

               -  Accepted clinical variants include, but are not necessarily limited to the
                  following:

                    -  lupus pernio

                    -  nodular

                    -  subcutaneous

                    -  annular

                    -  angiolupoid

                    -  plaque

                    -  papular

                    -  lichenoid

                    -  psoriasiform

               -  For purposes of this study "moderate to severe cutaneous sarcoidosis" is defined
                  as the presence of sarcoidal skin lesions with any of the following features:

                    -  At least 5 easily visible facial lesions, or

                    -  Disease which involves > 3% BSA, or

                    -  Disease which confers functional impairment (e.g. nasal or visual field
                       obstruction), or

                    -  Disease which confers significant symptoms of itching and/or pain.

          4. If female, subject is either not of childbearing potential, defined as postmenopausal
             for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral
             oophorectomy, or hysterectomy), or is using one of the following methods of birth
             control for the duration of the study and 90 days after study completion:

               -  condoms, sponge, foams, jellies, diaphragm, or intrauterine device

               -  contraceptives (oral or parenteral) for three months prior to study drug
                  administration

               -  a vasectomized sole partner

               -  Females of childbearing potential must have a negative serum pregnancy test at
                  screening visit.

        Exclusion Criteria:

          1. No consent/inability to obtain consent.

          2. Age less than 18 years of age.

          3. Inability to obtain biopsy or draw blood.

          4. CPK, ALT or AST >5 times upper limit of normal (ULN)

          5. Pregnancy or breast feeding.

          6. Current use of medications metabolized by rifampin (See Appendix).

          7. Allergy to macrolides, quinolones or rifamycins.

          8. Visual Impairment as defined by differentiating colors.

          9. Family or personal history of long QT syndromes.

         10. Patients receiving another interventional investigational drug within the 30 days
             prior to dosing

         11. Use of any investigational medication within the past 28 days prior to study
             enrollment.

         12. Subject has been hospitalized for infection or received IV antibiotics within the
             previous 2 months prior to baseline.

         13. Subject has a history of tuberculosis at anytime or close contact with a person with
             active tuberculosis within the previous 6 months, or persistent or active infections
             requiring hospitalization or treatment with IV antibiotics, IV antiretrovirals, or IV
             antifungals within 30 days of baseline, OR oral antibiotics, antivirals, or
             antifungals for purpose of treating infection, within 14 days of baseline.

         14. Evidence of other active skin diseases or skin infections during screening that may
             interfere with evaluation of sarcoidosis.

         15. Subject has an active infection requiring systemic antibiotics at time of screening

         16. Subject has a history of listeriosis, treated or untreated tuberculosis, exposure to
             individuals with tuberculosis.

         17. Subject has a variant of sarcoidosis that is not amenable to study evaluation, in the
             absence of chronic indurated lesions, such as:

               -  Acute, "benign" sarcoid associated with erythema nodosum

               -  Acute iritis

               -  Ichthyosiform sarcoidosis

               -  Hypo- or hyperpigmented macular sarcoidosis

               -  Ulcerative sarcoidosis

               -  Erythroderma

               -  Alopecia

         18. Patients otherwise unsuitable for participation in the opinion of the investigator
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
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