drugset / Trial / NCT00076726
A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Giant Cell Arteritis
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2003-11
- Primary completion
- —
- Completion
- 2005-07
Outcome
Missed primary endpoint
Stopped: “Interim analysis, infliximab did not reduce number of first relapses in GCA or cumulative glucocorticosteroid dosage”
paper Infliximab therapy did not increase the proportion of patients without relapse at week 22 compared with placebo (43% vs. 50% PMID 17470830 ↗
Publications
- Results 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Infliximab | Monoclonal antibody | 5 mg/kg | — |