Trial of Adalimumab in Progressive Sarcoidosis

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT00311246
Phase
PHASE2
Status
Terminated

Conditions

  • Sarcoidosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    Subjects will give themselves a dose of Adalimumab at 40 mg/every week by subcutaneous injection for a total of 45 weeks.

Study Details

Sarcoidosis is a rare disease that can affect any organ in the body. It is characterized by the buildup of immune-system (fights off infection in the body) cells in organs. These cells form small groups called granulomas, which lead to inflammation of the surrounding tissue. Sarcoidosis most commonly affects the lung and the lymph nodes (part of the immune system). The signs usually include shortness of breath, fever, dry cough, and chest pain. Other signs in many patients can include redness and painful lumps on the skin, reduced eyesight, joint pain, and rarely, nervous system damage. Sarcoidosis commonly affects young and middle-aged adults. There are no approved therapies for the treatment of sarcoidosis. Corticosteroid (steroid hormone) therapy is considered the standard treatment. Only limited benefit has been shown when using corticosteroid therapy to ease lung symptoms or improve lung function in patients with sarcoidosis. Also, the effects of other therapies (for example: methotrexate, cyclophosphamide, anti-malarial drugs, thalidomide) and other immunosuppressants (drugs that suppress a body's natural defense system \[immune system\]) which have been used in a small number of patients are not well known and can cause long term problems. The drug used in this study is called adalimumab. Adalimumab is FDA (Food and Drug Administration) approved for patients with moderately to severely active rheumatoid arthritis. However, adalimumab is not approved for the treatment of sarcoidosis. Adalimumab is experimental in this study. The purpose of this study is to evaluate the safety and effectiveness of adalimumab in the treatment of patients with sarcoidosis with pulmonary (lung) involvement who show symptoms of the disease even though they are currently being treated with medication.

Key Dates

Start date
Apr 30, 2006
Status verified
Mar 2020
Primary completion
May 31, 2008
Completion
Sep 30, 2008

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: An open-label
    Patients received adalimumab 40 mg weekly for 45 weeks, with a final follow-up at Week 52

Primary Outcome Measure

Change in FVC From Screening to Week 24 [ Time Frame: 24 Weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
The University of ChicagoChicagoIllinois60637-

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By research site
The University of Chicago· Chicago, IL

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