Trial of Adalimumab in Progressive Sarcoidosis

This study has been terminated.
(Difficulty in recruiting subjects)
Sponsor:
Collaborator:
Abbott
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00311246
First received: April 3, 2006
Last updated: June 28, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Sarcoidosis
Drug: Adalimumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Open-Label Trial of Adalimumab in Progressive Sarcoidosis

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • The primary objective of this study is to evaluate the efficacy and safety of adalimumab, as measured by pulmonary function, in subjects with chronic sarcoidosis with pulmonary involvement who are symptomatic despite current treatment. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the efficacy of adalimumab in improving the symptoms and functional capacity in patients with chronic sarcoidosis with pulmonary involvement who are symptomatic despite current treatment [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • To assess the effect of adalimumab on quality of life in subjects with chronic sarcoidosis with pulmonary involvement [ Time Frame: 12 Weeks & 24 Weeks ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: April 2006
Study Completion Date: September 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Adalimumab
    Subjects will give themselves a dose of Adalimumab at 40 mg/every week by subcuetaneous injection for a total of 45 weeks.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women > 18 years of age.
  • Sarcoidosis diagnosed at least 1 year prior to screening.
  • Histologically proven sarcoidosis prior to screening.
  • Have a diagnosis of sarcoidosis with evidence of parenchymal disease on chest radiograph (Stage II or III) or Stage I disease by chest radiographs and evidence of abnormal PFT as below or normal chest radiograph; or abnormal PFT, with abnormal chest computed tomography (CT) and evidence of sarcoid lung involvement by histology. Subjects with concurrent extrapulmonary sarcoidosis, particularly skin and eye involvement, are encouraged to be enrolled.
  • Have forced vital capacity (FVC) > 40 and < 80% of predicted.
  • Have an American Thoracic Society (ATS) dyspnea score of > Grade 1.
  • Have been receiving pre-study treatment that includes at least 10 mg/day prednisone (or equivalent dose of corticosteroid) as a single agent, or 1 or more immunosuppressant (e.g., methotrexate, azathioprine, cyclophosphamide, chloroquine, leflunomide, hydroxychloroquine, mycophenolate mofetil, cyclosporine, tacrolimus, corticosteroids) for at least the 3-month period immediately prior to screening. Subjects must be on a stable dose of these medications for > 4 weeks before starting the study medication.
  • Adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) must be used for the duration of the study and such precautions should be continued for 6 months after receiving the last study agent injection.
  • Are considered eligible based on TB screening

Exclusion Criteria:

  • Have used any investigational drug within 1 month prior to screening.
  • Have received previous administration of a treatment with any other therapeutic agent targeted at reducing tumor necrosis factor [TNF] (e.g., pentoxifylline, thalidomide, etanercept, infliximab) within 3 months prior to screening.
  • Have received previous administration of adalimumab.
  • Have received any live virus or bacterial vaccinations within the 3 months before the first dose of the study agent or are expected to receive any live virus or bacterial vaccinations during the trial or up to 3 months after the last dose of the study agent.
  • Have had any previous adverse reactions or allergic reactions (e.g., anaphylaxis) associated with the administration of monoclonal antibodies.
  • Have New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF).
  • Have a history of severe right-sided heart failure or cor pulmonale.
  • Have had serious infections within 2 months of screening. Less serious infections (such as acute upper respiratory tract infection [colds] or a simple urinary tract infection) need not be considered as exclusion at the discretion of the investigator.
  • Are considered ineligible according to the United States of America (USA)-specific TB screening.
  • Have or have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis and aspergilloma, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
  • Have a known infection with human immunodeficiency virus (HIV).
  • Have current signs and symptoms of systemic lupus erythematosus, or severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, or cerebral diseases (with the exception of sarcoidosis).
  • Presence of a transplanted organ (with the exception of a corneal transplant) > 3 months prior to screening.
  • Have any known malignancy or history of malignancy within 5 years prior to screening.
  • Have a history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease.
  • Are pregnant, nursing, or planning pregnancy (both men and women) during the trial or within the 6-month period thereafter.
  • Have had a known substance abuse or dependency, drug or alcohol within 3 years of screening.
  • Have poor tolerability of subcutaneous injection or lack of adequate venous access for required blood sampling.
  • Have a known history of demyelinating disease such as multiple sclerosis or optic neuritis.
  • Presence of a non-sarcoidosis condition affecting survival.
  • Have mental health problems interfering with participation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311246

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Abbott
Investigators
Principal Investigator: Nadera J. Sweiss, M.D. The University of Chicago Hospitals
  More Information

No publications provided

Responsible Party: Nadera Sweiss, MD, The University of Chicago
ClinicalTrials.gov Identifier: NCT00311246     History of Changes
Other Study ID Numbers: 14093A
Study First Received: April 3, 2006
Last Updated: June 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Chicago:
Sarcoidosis
Humira
Adalimumab
Tumor Necrosis Factor Inhibitors

Additional relevant MeSH terms:
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 18, 2014