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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004686
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : March 25, 2015
Information provided by:
FDA Office of Orphan Products Development

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.

Condition or disease Intervention/treatment Phase
Giant Cell Arteritis Drug: methotrexate Drug: prednisone Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : February 1994
Study Completion Date : September 1999

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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--


  • WBC at least 4,000/mm3
  • Platelet count at least 120,000/mm3
  • No acute or chronic liver disease


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004686

Sponsors and Collaborators
The Cleveland Clinic
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Study Chair: Gary Stuart Hoffman The Cleveland Clinic

Layout table for additonal information Identifier: NCT00004686    
Other Study ID Numbers: 199/13298
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 1999
Keywords provided by FDA Office of Orphan Products Development:
cardiovascular and respiratory diseases
giant cell arteritis
rare disease
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents