Efficacy Study of Humira in the Treatment of Cutaneous Sarcoidosis

NCT00731757 | Withdrawn Phase 2 DMC

• 1 other identifier: HUM 04-36
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and efficacy of Humira in the treatment of cutaneous sarcoidosis.

Conditions

Sarcoidosis; Cutaneous Sarcoidosis

Outcome Measures

Primary Outcomes (2)

• Change in Physician Global Assessment score from baseline to Week 24.

  week 0 and week 24.

• Change in Physician Target Lesion Assessment score from baseline to Week 24.

  Week 0 and week 24.

Secondary Outcomes (6)

• Number of complete responders, partial responders, minimal responders, and non-responders at Week 24.

  Week 0, week 1, week 4 and then every 4 weeks until week 24.

• Mean change in Body Surface Area by visit.

  Week 0, week 1, week 4 and then every 4 weeks until week 24.

• Change in Physician Global Assessment score by visit.

  Week 0, week 1, week 4 and then every 4 weeks until week 24.

• Change in Physician Target Lesion Assessment score by visit.

  Week 0, week 1, week 4 and then every 4 weeks until week 24.

• Mean change in the subject's evaluation of severity as measured by a 100 millimeter visual analogue scale by visit.

  Week 0, week 1, week 4 and then every 4 weeks until week 24.

Study Arms (1)

1

EXPERIMENTAL

Patients being treated with Humira.

Drug: Humira

Interventions

Humira DRUG

80 mg at week 0, then 40 mg weekly from week 1-week 23.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wright State University: lead
• Stanford University: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Sarcoidosis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Michael P Heffernan, MD

  Wright State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 6, 2008
• First Posted: August 11, 2008
• Study Start: May 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

US (1)