A Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Safety and Efficacy of Infliximab (Remicade�) in Subjects With Chronic Sarcoidosis With Pulmonary Involvement.
Data Collection
Hypersensitivity+3
+ Hypersensitivity, Delayed
+ Immune System Diseases
Treatment Study
Summary
Study start date: October 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.139 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives