A Study of Infliximab in Patients With Sarcoidosis

• ClinicalTrials.gov Identifier: NCT00073437
• Recruitment Status: Completed
• First Posted: November 24, 2003
• Last Update Posted: May 17, 2011
• Sponsor: Centocor, Inc.
• Information provided by: Centocor, Inc.

Study Description

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.

Study Design

• 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

Arms and Interventions

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

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 

Publications of Results:

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; Centocor T48 Sarcoidosis Investigators. Efficacy of infliximab in extrapulmonary sarcoidosis: results from a randomised trial. Eur Respir J. 2008 Jun;31(6):1189-96. doi: 10.1183/09031936.00051907. Epub 2008 Feb 6.

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):526-535. doi: 10.1378/chest.08-1876. Epub 2009 Apr 24.

• ClinicalTrials.gov Identifier: NCT00073437
• Other Study ID Numbers: CR005293
• First Posted: November 24, 2003
• Last Update Posted: May 17, 2011
• Last Verified: April 2010

Keywords provided by Centocor, Inc.:

Sarcoidosis; Infliximab; Pulmonary involvement; Remicade

Additional relevant MeSH terms:

Sarcoidosis; Lymphoproliferative Disorders; Lymphatic Diseases; Infliximab; Dermatologic Agents; Gastrointestinal Agents; Antirheumatic Agents