A Study of Infliximab in Patients With Sarcoidosis - Full Text View

Sponsor:	Centocor, Inc.
Information provided by:	Centocor, Inc.
ClinicalTrials.gov Identifier:	NCT00073437

Purpose

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	Intervention	Phase
Sarcoidosis	Drug: Infliximab	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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.

Resource links provided by NLM:

MedlinePlus related topics: Sarcoidosis

Drug Information available for: Infliximab

U.S. FDA Resources

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:

Change from baseline in the percent of predicted Full Vital Capacity (FVC) at week 24

Secondary Outcome Measures:

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.

Enrollment:	139
Study Start Date:	October 2003
Study Completion Date:	February 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073437

Sponsors and Collaborators

Centocor, Inc.

Investigators

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

More Information

Additional Information:

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Safety and Efficacy of Infliximab (REMICADE�) in Subjects with Chronic Sarcoidosis with Pulmonary Involvement This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Baughman RP, Drent M, Kavuru M, Judson MA, Costabel U, du Bois R, Albera C, Brutsche M, Davis G, Donohue JF, Müller-Quernheim J, Schlenker-Herceg R, Flavin S, Lo KH, Oemar B, Barnathan ES; Sarcoidosis Investigators. Infliximab therapy in patients with chronic sarcoidosis and pulmonary involvement. Am J Respir Crit Care Med. 2006 Oct 1;174(7):795-802. Epub 2006 Jul 13.

Judson MA, Baughman RP, Costabel U, Flavin S, Lo KH, Kavuru MS, Drent M; the Centocor T48 investigators. Efficacy of Infliximab in Extrapulmonary Sarcoidosis: Results from a Randomized Trial. Eur Respir J. 2008 Feb 6; [Epub ahead of print]

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sweiss NJ, Barnathan ES, Lo K, Judson MA, Baughman R; T48 Investigators. C-reactive protein predicts response to infliximab in patients with chronic sarcoidosis. Sarcoidosis Vasc Diffuse Lung Dis. 2010 Jul;27(1):49-56.

Baughman RP, Shipley R, Desai S, Drent M, Judson MA, Costabel U, du Bois RM, Kavuru M, Schlenker-Herceg R, Flavin S, Lo KH, Barnathan ES; Sarcoidosis Investigators. Changes in chest roentgenogram of sarcoidosis patients during a clinical trial of infliximab therapy: comparison of different methods of evaluation. Chest. 2009 Aug;136(2):526-35. Epub 2009 Apr 24.

ClinicalTrials.gov Identifier:	NCT00073437 History of Changes
Other Study ID Numbers:	CR005293
Study First Received:	November 20, 2003
Last Updated:	May 16, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:

Sarcoidosis
Infliximab
Pulmonary involvement
Remicade

Additional relevant MeSH terms:

Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Infliximab
Dermatologic Agents

Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012