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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.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00076726
Date of registration: 02/02/2004
Prospective Registration: No
Primary sponsor: Centocor, Inc.
Public title: A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Giant Cell Arteritis
Scientific title: A Randomized, Double-Masked, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Infliximab in Subjects With Giant Cell Arteritis
Date of first enrolment: November 2003
Target sample size: 44
Recruitment status: Terminated
URL:  http://clinicaltrials.gov/show/NCT00076726
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
Belgium Italy Spain United Kingdom United States
Contacts
Name:     Centocor, Inc. Clinical Trial
Address: 
Telephone:
Email:
Affiliation:  Centocor, Inc.
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients who have a diagnosis of Giant Cell Arteritis (GCA)

- Patients who have a diagnosis of GCA of = 4 weeks' duration

- Patients who are receiving = 40 mg/day of prednisone/prednisolone Exclusion Criteria:

- Patients must not have a prior diagnosis of GCA > 4 weeks

- Patients must not have failed to respond to glucocorticosteroid therapy within 5 days
of initiation of therapy.



Age minimum: 50 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Giant Cell Arteritis
Intervention(s)
Drug: Infliximab
Primary Outcome(s)
The proportion of relapse-free patients through Week 22 .
Secondary Outcome(s)
Proportion of relapse-free subjects through Week 54, time to first relapse, levels of biochemical markers of inflammation and disease activity (eg, ESR, C-reactive protein [CRP], interleukin [IL]-6) , cumulative dose of prednisone (or equivalents)
Secondary ID(s)
CR003139
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
The Cleveland Clinic
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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