Back to resultsA Study of Infliximab in Patients With Sarcoidosis
Primary Purpose
Sarcoidosis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Infliximab
Sponsored by
About this trial
This is an interventional treatment trial for Sarcoidosis focused on measuring Sarcoidosis, Infliximab, Pulmonary involvement, Remicade
Eligibility 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
Sites / Locations
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00073437
Brief Title
A Study of Infliximab in Patients With Sarcoidosis
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 Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centocor, Inc.
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis
Keywords
Sarcoidosis, Infliximab, Pulmonary involvement, Remicade
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Infliximab
Primary Outcome Measure Information:
Title
Change from baseline in the percent of predicted Full Vital Capacity (FVC) at week 24
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Centocor, Inc. Clinical Trial
Organizational Affiliation
Centocor, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
16840744
Citation
Baughman RP, Drent M, Kavuru M, Judson MA, Costabel U, du Bois R, Albera C, Brutsche M, Davis G, Donohue JF, Muller-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. doi: 10.1164/rccm.200603-402OC. Epub 2006 Jul 13.
Results Reference
result
PubMed Identifier
18256069
Citation
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.
Results Reference
result
PubMed Identifier
21086905
Citation
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.
Results Reference
derived
PubMed Identifier
19395578
Citation
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=161&filename=CR005293_CSR.pdf
Description
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Safety and Efficacy of Infliximab (REMICADE�) in Subjects with Chronic Sarcoidosis with Pulmonary Involvement
Learn more about this trial
A Study of Infliximab in Patients With Sarcoidosis
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