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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 February 2015
Main ID:  NCT00073437
Date of registration: 20/11/2003
Prospective Registration: Yes
Primary sponsor: Centocor, Inc.
Public title: A Study of Infliximab in Patients With Sarcoidosis
Scientific 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.
Date of first enrolment: October 2003
Target sample size: 139
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Austria Belgium France Germany Italy Netherlands Sweden Switzerland
United Kingdom United States
Name:     Centocor, Inc. Clinical Trial
Affiliation:  Centocor, Inc.
Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Drug: Infliximab
Primary Outcome(s)
Change from baseline in the percent of predicted Full Vital Capacity (FVC) at week 24
Secondary Outcome(s)
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.
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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