A Study of Infliximab in Patients With Sarcoidosis

Centocor Ortho Biotech

Status and phase

Completed

Phase 3

Conditions

Sarcoidosis

Treatments

Drug: Infliximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00073437

CR005293

Details and patient eligibility

About

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.

Full 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.

Enrollment

139 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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