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

NCT00076726 | Terminated Phase 2 DMC

• 1 other identifier: CR003139
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Giant Cell Arteritis

Keywords

Giant Cell Arteritis; infliximab

Outcome Measures

Primary Outcomes (1)

• The proportion of relapse-free patients through Week 22 .

Secondary Outcomes (1)

• 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)

Interventions

Infliximab DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have a diagnosis of Giant Cell Arteritis (GCA)
• Patients who have a diagnosis of GCA of = 4 weeks' duration

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centocor, Inc.: lead
• The Cleveland Clinic: collaborator

Related Publications (2)

• 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. doi: 10.7326/0003-4819-146-9-200705010-00004.

  PMID: 17470830 RESULT

• Visvanathan S, Rahman MU, Hoffman GS, Xu S, Garcia-Martinez A, Segarra M, Lozano E, Espigol-Frigole G, Hernandez-Rodriguez J, Cid MC. Tissue and serum markers of inflammation during the follow-up of patients with giant-cell arteritis--a prospective longitudinal study. Rheumatology (Oxford). 2011 Nov;50(11):2061-70. doi: 10.1093/rheumatology/ker163. Epub 2011 Aug 25.

  PMID: 21873264 DERIVED

Related Links

• A Randomized, Double-masked, Placebo-controlled, Multicenter Study of the Safety and Efficacy of Infliximab in Subjects with Giant Cell Arteritis

MeSH Terms

Conditions

Giant Cell Arteritis

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Centocor, Inc. Clinical Trial

  Centocor, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 2, 2004
• First Posted: February 4, 2004
• Study Start: November 1, 2003
• Study Completion: July 1, 2005
• Last Updated: May 17, 2011

Record last verified: 2010-04