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

NCT00004686 | Completed Phase 2

• 4 other identifiers: 199/13298CCF-RPC-4586CCF-FDR001040DPT-32-0-48
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

cardiovascular and respiratory diseases; giant cell arteritis; rare disease

Interventions

methotrexate DRUG

prednisone DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of giant cell arteritis (GCA) by at least one of the following: * Temporal artery biopsy confirming GCA Symptoms of GCA (including new onset (within 6 months) symptoms of headaches, tenderness of the scalp or the temporal arteries, visual loss due to retinal ischemic optic neuropathy or otherwise unexplained tongue or jaw pain) and an aortic angiogram that revealed stenotic and/or aneurysmal disease of the aorta and its principal branches * Symptoms of polymyalgia rheumatica plus ischemic optic neuropathy, newly identified tenderness over a temporal artery, or new onset of tongue or jaw pain Westergren erythrocyte sedimentation rate of at least 40 nm in one hour --Prior/Concurrent Therapy-- Endocrine therapy: No greater than 20 days since initiation of prednisone therapy Other: No concurrent sulfa drugs or nonsteroidal antiinflammatory drugs --Patient Characteristics-- Hematopoietic: * WBC at least 4,000/mm3 * Platelet count at least 120,000/mm3 * No acute or chronic liver disease Hepatic: * Alkaline phosphatase no greater than 2 times upper limit of normal * No other reproducible abnormal liver function test Renal: Creatinine less than 2.0 mg/dL Other: * HIV negative * No symptomatic peptic ulcer disease within the last 3 months * Hepatitis B or C antigen negative * No alcohol use in excess of 2 ounces of 100 proof liquor or 1 beer or its equivalent per week * No insulin dependent diabetes mellitus plus morbid obesity (greater than 33% over ideal body weight) * No recently (less than 6 months) diagnosed malignancy * Not pregnant or nursing * Adequate contraception required of all fertile patients

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The Cleveland Clinic: lead

MeSH Terms

Conditions

Giant Cell Arteritis; Respiratory Tract Diseases; Rare Diseases

Interventions

Methotrexate; Prednisone

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Gary Stuart Hoffman

  The Cleveland Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 24, 2000
• First Posted: February 25, 2000
• Study Start: February 1, 1994
• Study Completion: September 1, 1999
• Last Updated: March 25, 2015

Record last verified: 1999-03