Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001677
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Methotrexate Alone Versus Combination of Methotrexate and Subcutaneous Fludarabine for Severe Rheumatoid Arthritis Safety Tolerance and Efficacy
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Methotrexate Alone Versus Combination of Methotrexate and Subcutaneous Fludarabine for Severe Rheumatoid Arthritis Safety Tolerance and Efficacy
Status:
COMPLETED
Status Verified Date:
1999-05
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:
The safety profile and efficacy of combination therapy will be evaluated using methotrexate MTX and the nucleoside analog fludarabine in 40 patients with severe refractory rheumatoid arthritis The patients enrolled will be those who have experienced inadequate disease control with MTX alone or in combination with other immunosuppressive drugs such as sulfasalazine SSZ cyclosporin A CsA or hydroxychloroquine HCQ In this randomized double-blind placebo controlled trial patients will be maintained on oral MTX at 175 mgweek to which either placebo or subcutaneous fludarabine at 30 mgm2 daily for three consecutive days per month will be added for four months The fludarabine or placebo treatment period will be followed by two months of follow-up at which time patients will be evaluated for response Patients will be monitored for adverse effectstolerability disease activity and changes in synovial volume as measured by magnetic resonance imaging MRI Additionally synovial biopsies will be obtained before and after treatment for investigation of infiltrating cell numbers and phenotypes cytokine profiles Th1 versus Th2 responses and angiogenesis
Detailed Description:
The safety profile and efficacy of combination therapy will be evaluated using methotrexate MTX and the nucleoside analog fludarabine in 40 patients with severe refractory rheumatoid arthritis The patients enrolled will be those who have experienced inadequate disease control with MTX alone or in combination with other immunosuppressive drugs such as sulfasalazine SSZ cyclosporin A CsA or hydroxychloroquine HCQ In this randomized double-blind placebo controlled trial patients will be maintained on oral MTX at 175 mgweek to which either placebo or subcutaneous fludarabine at 30 mgm2 daily for three consecutive days per month will be added for four months The fludarabine or placebo treatment period will be followed by two months of follow-up at which time patients will be evaluated for response Patients will be monitored for adverse effectstolerability disease activity and changes in synovial volume as measured by magnetic resonance imaging MRI Additionally synovial biopsies will be obtained before and after treatment for investigation of infiltrating cell numbers and phenotypes cytokine profiles Th1 versus Th2 responses and angiogenesis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 98-AR-0117 | None | None | None |