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A Study of Infliximab in Patients With Sarcoidosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00073437
Recruitment Status : Completed
First Posted : November 24, 2003
Last Update Posted : May 17, 2011
Sponsor:
Information provided by:
Centocor, Inc.

Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of infliximab (Remicade) in patients with Chronic Sarcoidosis. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.

Condition or disease Intervention/treatment Phase
Sarcoidosis Drug: Infliximab Phase 3

Detailed Description:
The purpose of this study is to evaluate the safety and effectiveness of infliximab in the treatment of subjects with sarcoidosis with pulmonary involvement who show symptoms of the disease even though they are currently being treated with medication. Patients will receive either placebo, 3 mg/kg infliximab, or 5 mg/kg infliximab infusions at weeks 0, 2, 6, 12, 18, and 24. Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. Patients will receive infusions of Infliximab (Remicade) 3 or 5 mg/kg or placebo at weeks 0, 2, 6, 12, 18 and 24.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Safety and Efficacy of Infliximab (Remicade�) in Subjects With Chronic Sarcoidosis With Pulmonary Involvement.
Study Start Date : October 2003
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis
Drug Information available for: Infliximab




Primary Outcome Measures :
  1. Change from baseline in the percent of predicted Full Vital Capacity (FVC) at week 24

Secondary Outcome Measures :
  1. Change from baseline in Saint George's Respiratory Questionnaire total score, Change from baseline in the 6-minute walk distance, Change from baseline in Borg's CR10 dyspnea score, proportion of LuPGA responders at week 24.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have been diagnosed with sarcoidosis at least 1 year prior to entry into the study
  • Patients must have laboratory test diagnosing sarcoidosis prior to screening
  • Patients must have a diagnosis of sarcoidosis by chest x- ray

Exclusion Criteria:

  • Patients must not have used any investigational drug within 1 month prior to entering the study
  • Patients must not have received previous administration of a treatment with any other therapeutic agent targeted at reducing TNF such as pentoxifylline, thalidomide, etanercept, CDP 870, adalimumab, within 3 months prior to screening
  • Patients must not have received vaccinations within 3 months

Information from the National Library of Medicine

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): NCT00073437


Sponsors and Collaborators
Centocor, Inc.
Investigators
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Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00073437     History of Changes
Other Study ID Numbers: CR005293
First Posted: November 24, 2003    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: April 2010

Keywords provided by Centocor, Inc.:
Sarcoidosis
Infliximab
Pulmonary involvement
Remicade

Additional relevant MeSH terms:
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Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents