A Controlled Trial of Intermittent Fludarabine for Psoriatic Arthritis
Completed
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phase 2
1995-06-01
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.
Methotrexate Alone Versus Combination of Methotrexate and Subcutaneous Fludarabine for Severe Rheumatoid Arthritis: Safety, Tolerance and Efficacy
Completed
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phase 2
1998-06-01
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 17.5
mg/week to which either placebo or subcutaneous fludarabine at 30 mg/m(2) 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 effects/tolerability, 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.
Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis
Completed
University of Rochester
Phase 2
1996-05-01
OBJECTIVES:
I. Assess the safety and efficacy of olsalazine, a dimer of 5-aminosalicylic acid, in men
with ankylosing spondylitis unresponsive to nonsteroidal anti-inflammatory drugs and
physiotherapy.
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