A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Giant Cell Arteritis - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 2, 2004

Last Updated Date

April 18, 2008

Start Date ^†

November 2003

Current Primary Outcome Measures ^†

The proportion of relapse-free patients through Week 22 .

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00076726 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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)

Original Secondary Outcome Measures ^†

The proportion of relapse-free subjects through Week 54
The time to first relapse
The levels of biochemical markers of inflammation and disease activity (eg, ESR, C-reactive protein [CRP], interleukin [IL]-6)
The cumulative dose of prednisone (or prednisone equivalent)

Descriptive Information

Brief Title ^†

A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Giant Cell Arteritis

Official Title ^†

A Randomized, Double-Masked, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Infliximab in Subjects With Giant Cell Arteritis

Brief Summary

The purpose of this study is to evaluate the safety and efficacy (effectiveness) of Infliximab (Remicade) in patients with Giant Cell Arteritis.

Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.

Detailed Description

The purpose of this study is to see if infliximab is safe and effective in treating GCA. Currently, the only treatment for GCA is prednisone. GCA is a long lasting inflammatory disease. The cause is unknown. It may affect all the arteries, but it focuses on the big vessels such as those around the heart, the vessels in the neck and head, and their major branches. It can lead to vision loss, blindness, stroke, stenosis (narrowing of blood vessels) and aneurysms (a weakening in the lining of the blood vessel wall, which may eventually lead to rupture of the blood vessel). The damage to the arteries is caused by an immune response. A naturally occurring substance in the immune system called "tumor necrosis factor alpha" (TNFa) plays a significant role in this immune response against the blood vessels. This response is thought to cause the long-lasting inflammation (irritation and swelling of the vessels). By blocking the effect of TNFa we think that we may reduce the signs and symptoms associated with GCA. This trial will study patients who are stable on prednisone treatment by evaluating whether infliximab can control their symptoms as the dose of prednisone is reduced.

Patients will receive infusions of either 5mg/kg of inflixmab or placebo at weeks 0, 2, 6, 14, 22, 30, 38, and 46. 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 receive infusions of either 5mg/kg inflixmab or placebo infusions at weeks 0, 2, 6, 14, 22, 30, 38, and 46.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Giant Cell Arteritis

Intervention ^†

Drug: Infliximab

Study Arms / Comparison Groups

Publications *

Hoffman GS, Cid MC, Rendt-Zagar KE, Merkel PA, Weyand CM, Stone JH, Salvarani C, Xu W, Visvanathan S, Rahman MU; Infliximab-GCA Study Group. Infliximab for maintenance of glucocorticosteroid-induced remission of giant cell arteritis: a randomized trial. Ann Intern Med. 2007 May 1;146(9):621-30. Summary for patients in: Ann Intern Med. 2007 May 1;146(9):I12.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Terminated

Estimated Enrollment ^†

Completion Date

July 2005

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00076726

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Centocor, Inc.

Collaborators ^††

The Cleveland Clinic
International Network for the Study of Systematic Vasculitides

Investigators ^†

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

Information Provided By

Centocor, Inc.

Verification Date

April 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.