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

NCT00004686 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2015-03-25

No results posted yet for this study

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.

Conditions

  • Giant Cell Arteritis

Interventions

DRUG

methotrexate

DRUG

prednisone

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Gary Stuart Hoffman · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1994-02-28
Completion
1999-09-30

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004686 on ClinicalTrials.gov