Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001422
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Controlled Trial of Intermittent Fludarabine for Psoriatic Arthritis
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Controlled Trial of Intermittent Fludarabine for Psoriatic Arthritis
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:
This is a placebo controlled study evaluating the role of fludarabine a nucleoside analog targeting both resting and proliferating lymphocytes in the treatment of moderate to severe psoriotic arthritis Patients should have failed at least one disease modifying antirheumatic drug
Detailed Description:
The efficacy and toxicity of immunosuppressive therapy using the adenine analogue fludarabine will be evaluated in 20 patients with psoriatic arthritis who have failed or have developed intolerable side-effects to at least one disease modifying antirheumatic drug including sulfasalazine gold methoxypsoralen and long wave ultraviolet A light PUVA retinoids methotrexate or cyclosporin In this double-blind placebo-controlled trial patients will receive a four month course of intravenous fludarabine 30 mgm2day for 2-3 days every 4 weeks for a total of four cycles or placebo by a block randomization procedure to ensure groups balanced for disease activity After a washout period of two months the patients receiving placebo will have the option of crossing over to the fludarabine arm for an additional four months of treatment Disease activity both skin and joints will be monitored throughout the study At the end of the study physician and patient assessment of disease activity as well as drug-related toxicities will be analyzed
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 |
|---|---|---|---|
| 95-AR-0140 | None | None | None |