Clinical trial: Efficacy Study of Humira in the Treatment of Cutaneous Sarcoidosis (NCT00731757)

Eligibility criteria:
Inclusion Criteria:

          -  Subject is willing and able to give informed consent.

          -  Subject is willing and able to participate in the study as an outpatient and is
             willing to comply with study requirements.

          -  Subject is 18 years of age or older.

          -  Subject has a diagnosis of cutaneous sarcoidosis for greater than 6 months with a
             physician global assessment score of at least 4. Diagnosis (based on the
             recommendations of an expert panel 24) 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 another clinical feature suggesting sarcoidosis (bilateral hilar
                  adenopathy, erythema nodosum, uveitis, raised ACE level, BAL lymphocytosis
                  (CD4:CD8>3.5), panda/lambda sign on gallium scan)

          -  If female of childbearing potential, subject will have a negative urine pregnancy test
             at Screening and Week 0.

          -  If female, subject will be either post-menopausal for > 1 year, surgically sterile
             (hysterectomy or bilateral tubal ligation), or practicing one form of birth control
             (abstinence, oral contraceptive, estrogen patch, implant contraception, injectable
             contraception, IUD, diaphragm, condom, sponge, spermicides, or vasectomy of partner).
             Female subjects will continue to use contraception for 6 months following the last
             infusion.

          -  Screening laboratory results are within the following parameters:

               -  Hemoglobin > 9 g/dL

               -  White blood cells > 3.0 x 10 to the 9th power/L, <14.0 x 10 to the 9th power/L
                  (unless on oral corticosteroids and no signs/symptoms of infection)

               -  Neutrophils > 1.5 x 10to the 9th power/L

               -  Platelets > 100 x 10 to the 9th power/L

               -  Lymphocytes > 0.5 x 10 to the 9th power/L

               -  Serum creatinine within 1.5 times the upper limit of normal range

               -  AST and ALT within 2 times the upper limit of normal range

          -  Subject has been on a stable dose of antibiotics, thalidomide, antimalarials, oral
             corticosteroids or other immunosuppressives, such cyclosporine, tacrolimus,
             azathioprine, methotrexate, or mycophenolate mofetil over the previous 4 weeks.

        Exclusion Criteria:

          -  Subject has evidence of a clinically significant, unstable or poorly controlled
             medical condition including unstable systemic sarcoidosis.

          -  Subject has a chest X-ray consistent with an active infection or previous exposure to
             TB and/or a positive purified protein derivative test at screening (>5 mm).

          -  Subject has a serious, active or recurrent bacterial, viral, or fungal infection. This
             includes hepatitis B and C, and HIV.

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

          -  Subject has a history of tuberculosis at anytime or close contact with a person with
             active tuberculosis within the previous 6 months.

          -  Subject has received a live vaccination within the previous 3 months.

          -  Subject has a history of a central nervous system disorder/demyelinating disease or
             symptoms suggestive of multiple sclerosis or optic neuritis.

          -  Subject has current signs or symptoms or history of systemic lupus erythematosus.

          -  Subject has been diagnosed with a malignancy within the past 5 years except for
             successfully treated non-melanoma skin cancer.

          -  Subject has signs or symptoms suggestive of a possible lymphoproliferative disease.

          -  Subject has a diagnosis of severe congestive heart failure (Class III or IV NYHA).

          -  Subject has had a substance abuse problem within the previous 3 years.

          -  Subject has any dermatologic disease in the target site that may be exacerbated by
             treatment or interfere with examination.

          -  Subject has been treated with an anti-TNF biologic immune response modifier, such as
             infliximab, adalimumab, or etanercept within the past 8 weeks.

          -  Subject has been treated with topical corticosteroids, tacrolimus, or pimecrolimus
             within 2 weeks or intralesional corticosteroids within 4 weeks of baseline.

          -  Subject has been administered an investigational drug in another clinical study within
             30 days prior to baseline (or 5 half-lives, whichever is longer).

          -  Subject has a known allergy to adalimumab.

          -  Subject is female and is pregnant, is considering becoming pregnant during the study
             and for 6 months afterwards, or is nursing.
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