A Study of Infliximab in Patients With Sarcoidosis - Tabular View

Tracking Information

First Received Date ^ICMJE

November 20, 2003

Last Updated Date

March 24, 2008

Start Date ^ICMJE

October 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Change from baseline in the percent of predictedFVC at week 24

Change History

Complete list of historical versions of study NCT00073437 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Change from baseline in Saint George’s Respiratory Questionnaire total score atweek 24
Change from baseline in the 6-minute walk distance at week 24
Change from baseline in Borg’s CR10 dyspnea score (score obtained before the 6-minute walk)at week 24
Proportion of lupus pernio Physician’s Global Assessment (LuPGA) responders as measured by a score of 1 or 2 in the LuPGA at week 24 for the subset of subjects with skin involvement at baseline

Descriptive Information

Brief Title ^ICMJE

A Study of Infliximab in Patients With Sarcoidosis

Official Title ^ICMJE

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Infliximab (Remicade®) in Subjects With Chronic Sarcoidosis With Pulmonary Involvement.

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Sarcoidosis

Intervention ^ICMJE

Drug: Infliximab

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

120

Completion Date

February 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00073437

Responsible Party

Study ID Numbers ^ICMJE

CR005293

Study Sponsor ^ICMJE

Centocor, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

Information Provided By

Centocor, Inc.

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP