Study to Determine the Efficacy of Adalimumab in the Treatment of Cutaneous Sarcoidosis

NCT00690911 | Withdrawn Phase 2

• 2 other identifiers: 0000216132409
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to see if Humira is effective and safe in the treatment of sarcoidosis.

Conditions

Sarcoidosis

Outcome Measures

Primary Outcomes (1)

• Change in PGA score.

  24 weeks

Secondary Outcomes (1)

• Number of complete responders, partial responders, minimal responders, and non-responders

  24 weeks

Study Arms (1)

1

EXPERIMENTAL

open label adalimumab 40mg

Drug: adalimumab

Interventions

adalimumab DRUG

40mg dose subcutaneously using sterile technique. The site research staff will instruct and supervise subjects or a designee or nurse on proper injection technique during site visit evaluations. Subjects or a reliable designee will administer injectable study drug at home in between site visit evaluations.

Also known as: Humira

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 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 study parameters.
• 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.

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

• Wake Forest University: lead

Study Sites (1)

Wake Forest University Health Sciences Dermatology

Winston-Salem, North Carolina, 27157, 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

• Joseph Jorizzo, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2008
• First Posted: June 5, 2008
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

US (1)