A Study of Infliximab in Patients With Sarcoidosis

Sarcoidosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00073437
• Other study ID #: CR005293
• Status: Completed
• Phase: Phase 3
• First received: November 20, 2003
• Last updated: May 16, 2011
• Start date: October 2003
• Est. completion date: February 2005

Study information

• Verified date: April 2010
• Source: Centocor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoidosis

Intervention

Drug:
• Infliximab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centocor, Inc.

References & Publications (2)

Baughman RP, Drent M, Kavuru M, Judson MA, Costabel U, du Bois R, Albera C, Brutsche M, Davis G, Donohue JF, Müller-Quernheim J, Schlenker-Herceg R, Flavin S, Lo KH, Oemar B, Barnathan ES; Sarcoidosis Investigators. Infliximab therapy in patients with chr — View 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: 10.1183/0903 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the percent of predicted Full Vital Capacity (FVC) at week 24
Secondary	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.

External Links

•   A Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Safety and Efficacy of Infliximab (REMICADE?) in Subjects with Chronic Sarcoidosis with Pulmonary Involvement