Trial of Adalimumab in Progressive Sarcoidosis
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|ClinicalTrials.gov Identifier: NCT00311246|
Recruitment Status : Terminated (Difficulty in recruiting subjects)
First Posted : April 5, 2006
Results First Posted : August 14, 2020
Last Update Posted : August 25, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoidosis||Drug: Adalimumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Open-Label Trial of Adalimumab in Progressive Sarcoidosis|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||September 2008|
Experimental: An open-label
Patients received adalimumab 40 mg weekly for 45 weeks, with a final follow-up at Week 52
Subjects will give themselves a dose of Adalimumab at 40 mg/every week by subcutaneous injection for a total of 45 weeks.
Other Name: Humira
- Change in FVC From Screening to Week 24 [ Time Frame: 24 Weeks ]The forced vital capacity (FVC) measurement shows the amount of air a person can forcefully and quickly exhale after taking a deep breath. Improvement in FVC, if significant, means better breathing and lung function. The change in FVC done at screening and at week 24 were compared to notice if there were any changes.
- Change in Distance Walked During 6 Minute Walk Test at Screening and 24 Weeks [ Time Frame: 24 weeks ]This is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes
- A Change in the Borg Dyspnea Score Before/After the 6 Minute Walk at Screening (S) and at 24 Weeks (W). [ Time Frame: 24 weeks ]This scale was used to measure a patients breathlessness before/after the 6 Minute Walk. This score was used at Screening (S) and at 24 weeks (W). The borg scale ranges from zero to 10 with zero being no breathlessness at all and 10 being maximal breathlessness. A change between screening and week 24 is reported.
- Physicians Global Assessment of Disease Activity. [ Time Frame: 24 weeks ]This assessment to determine the level of disease activity. Scores range from 0 (no pulmonary manifestations of sarcoidosis) to 100 (worsening of pulmonary symptoms) on a visual analog scale.
- Patient's Global Assessment of Disease Activity. [ Time Frame: 24 weeks ]This is the patients measurement of disease activity. Scores range from 0 (no pulmonary manifestations of sarcoidosis) to 100 (worsening of pulmonary symptoms) on a visual analog scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311246
|United States, Illinois|
|The University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Nadera J. Sweiss, M.D.||The University of Chicago Hospitals|