Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004686
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2000-02-24
Brief Title:
Phase II Randomized Study of Glucocorticoids With or Without Methotrexate for Treatment of Giant Cell Arteritis
Sponsor:
The Cleveland Clinic
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1999-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Patients are followed for 1-6 years
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DPT-32-0-48 | None | None | None |
| CCF-RPC-4586 | None | None | None |
| CCF-FDR001040 | None | None | None |