Phase II Randomized Study of Glucocorticoids With or Without Methotrexate for Treatment of Giant Cell Arteritis - Full Text View

Sponsor:	FDA Office of Orphan Products Development
Collaborator:	The Cleveland Clinic
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004686

Purpose

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	Intervention	Phase
Giant Cell Arteritis	Drug: methotrexate Drug: prednisone	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind

Resource links provided by NLM:

MedlinePlus related topics: Polymyalgia Rheumatica

Drug Information available for: Prednisone Methotrexate

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	300
Study Start Date:	February 1994

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004686

Sponsors and Collaborators

FDA Office of Orphan Products Development

The Cleveland Clinic

Investigators

Study Chair:

Gary Stuart Hoffman

The Cleveland Clinic

More Information

No publications provided

Study ID Numbers:	199/13298, CCF-RPC-4586, CCF-FDR001040, DPT-32-0-48
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004686 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

cardiovascular and respiratory diseases
giant cell arteritis
rare disease

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Prednisone
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Vasculitis, Central Nervous System
Reproductive Control Agents
Brain Diseases
Hormones
Cerebrovascular Disorders
Musculoskeletal Diseases

Therapeutic Uses
Abortifacient Agents
Connective Tissue Diseases
Methotrexate
Cardiovascular Diseases
Arteritis
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Autoimmune Diseases of the Nervous System
Skin Diseases, Vascular
Vasculitis
Autoimmune Diseases
Antineoplastic Agents, Hormonal
Skin Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on November 30, 2009