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

Primary Purpose

Giant Cell Arteritis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
methotrexate
prednisone
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Giant Cell Arteritis focused on measuring cardiovascular and respiratory diseases, giant cell arteritis, rare disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    March 24, 2015
    Sponsor
    The Cleveland Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004686
    Brief Title
    Phase II Randomized Study of Glucocorticoids With or Without Methotrexate for Treatment of Giant Cell Arteritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 1999
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1994 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 1999 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    The Cleveland Clinic

    4. Oversight

    5. Study Description

    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.
    Detailed Description
    PROTOCOL OUTLINE: This is a randomized, double blind, multicenter study. Patients are randomized into initial therapy with prednisone plus weekly placebo or prednisone plus weekly oral methotrexate. Patients who do not respond to treatment within 5 days are taken off study. If methotrexate toxicity dose not occur after 2 weeks, methotrexate is increased by one tablet per week until a maximum tolerated dose (MTD) is achieved. The MTD of methotrexate or the matching placebo dose is continued for 12 months in the absence of toxicity. Once 12 continuous months of remission are achieved, methotrexate or placebo is tapered to discontinuation. Patients are followed for 1-6 years. Completion date provided represents the completion date of the grant per OOPD records

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Giant Cell Arteritis
    Keywords
    cardiovascular and respiratory diseases, giant cell arteritis, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    300 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    methotrexate
    Intervention Type
    Drug
    Intervention Name(s)
    prednisone

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gary Stuart Hoffman
    Organizational Affiliation
    The Cleveland Clinic
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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