A Study of Infliximab in Patients With Sarcoidosis

May 16, 2011 updated by: Centocor, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

139

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centocor, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Study Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

November 20, 2003

First Submitted That Met QC Criteria

November 21, 2003

First Posted (Estimate)

November 24, 2003

Study Record Updates

Last Update Posted (Estimate)

May 17, 2011

Last Update Submitted That Met QC Criteria

May 16, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR005293

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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