Giant Cell ArteritisPhase 2NCT00004686
Phase II Randomized Study of Glucocorticoids With or Without Methotrexate for Treatment of Giant Cell Arteritis
A Phase 2 study testing methotrexate and prednisone in people with Giant Cell Arteritis, run by The Cleveland Clinic.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Giant Cell Arteritis
- What is being tested?
- methotrexate and prednisone
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Feb 1994to Sep 1999
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
About this study
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.
Read the 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
- Conditions
- Giant Cell Arteritis
- Being tested
- methotrexate, prednisone
- Keywords
- cardiovascular and respiratory diseases, giant cell arteritis, rare disease
- Medical subject headings
- Giant Cell Arteritis, Respiratory Tract Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methotrexateDrug
prednisoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startFeb 1994
- Study completionSep 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Gary Stuart Hoffman, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004686
- Sponsor's protocol ID
- 199/13298
- Other IDs
- CCF-RPC-4586, CCF-FDR001040, DPT-32-0-48
- Status last verified
- Mar 1999
- First submitted
- 24 Feb 2000
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Study of Glucocorticoids With or Without Methotrexate for Treatment of Giant Cell Arteritis
- ClinicalTrials.gov ID
- NCT00004686
- Acronym / sponsor ID
- 199/13298
- Conditions
- Giant Cell Arteritis
- Keywords
- cardiovascular and respiratory diseases, giant cell arteritis, rare disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Feb 1994
- Study completion
- Sep 1999
- First posted
- 25 Feb 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methotrexate | Drug | – |
| prednisone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
Related trials for Giant Cell Arteritis
Not yet recruitingPhase 3
Aspirin for the Prevention of Ischemic Complications in Giant Cell Arteritis
Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS)
RecruitingObservational study
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Takayasu's Arteritis, Giant Cell Arteritis
RecruitingObservational study
Optic Nerve Sheath Ultrasound in Giant Cell Arteritis
Giant Cell Arteritis, Anterior Ischemic Optic Neuropathy
Active, not recruitingObservational study
The Applanation Tonometry in GCA Pilot
Giant Cell Arteritis
RecruitingObservational study
Early Temporal Dynamics of Optic Nerve Sheath Diameter After Therapy in GCA
Giant Cell Arteritis, Temporal Arteritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Stuart Hoffman study chair
The Cleveland Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing methotrexate and prednisone in people with Giant Cell Arteritis, run by The Cleveland Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.