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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 1999 by FDA Office of Orphan Products Development.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004686
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: March 1999
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

ClinicalTrials.gov Identifier: NCT00004686     History of Changes
Other 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
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:
Arteritis
Giant Cell Arteritis
Polymyalgia Rheumatica
Vascular Diseases
Cardiovascular Diseases
Vasculitis
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
Glucocorticoids
Prednisone
Methotrexate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on July 29, 2014