drugset / Trial / NCT00004686

Phase II Randomized Study of Glucocorticoids With or Without Methotrexate for Treatment of Giant Cell Arteritis

NCT00004686 ↗

Phase 2 Completed 300 enrolled The Cleveland Clinic
RandomizedDouble-blindTreatment

Summary

OBJECTIVES: I. Compare the long term outcomes in patients with giant cell arteritis after glucocorticoid treatment with or without methotrexate. II. Compare remission relapse rates in these patients after glucocorticoid therapy with or without methotrexate. III. Determine whether adjunctive use of methotrexate lowers cumulative dose and duration of glucocorticoid therapy and whether there is less treatment related morbidity and mortality. IV. Demonstrate the feasibility of long term, double blind, placebo controlled, randomized, multicenter trials for treatment of systemic vasculitides.

Timeline

Start
1994-02
Primary completion
—
Completion
1999-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Methotrexate Small molecule — Oral
Subject Prednisone Other / unclassified — —

Indications