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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR SULFASALAZINE

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Clinical Trials for Sulfasalazine

Trial ID Title Status Sponsor Phase Summary
NCT00001422 A Controlled Trial of Intermittent Fludarabine for Psoriatic Arthritis Completed National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Phase 2 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.
NCT00001677 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 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.
NCT00004288 Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis Completed University of Rochester Phase 2 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.
NCT00004288 Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis Completed National Center for Research Resources (NCRR) Phase 2 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.
NCT00004810 Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis Completed University of Vermont Phase 2 OBJECTIVES: I. Assess the safety and efficacy of 4-aminosalicylic acid in patients with mildly to moderately severe ulcerative colitis.
NCT00004810 Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis Completed National Center for Research Resources (NCRR) Phase 2 OBJECTIVES: I. Assess the safety and efficacy of 4-aminosalicylic acid in patients with mildly to moderately severe ulcerative colitis.
NCT00007163 Monoclonal Antibody Treatment of Crohn's Disease Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 This study will examine the safety and effectiveness of an experimental drug called J695 for treating patients with Crohn's disease-a long-term recurring inflammation of the small and large intestine. This disease is currently treated with steroids, sulfasalazine (Azulfidine), 5-ASA drugs (Pentasa, Asacol), immune suppressants, antibiotics, and an antibody against TNF-alpha. Despite the number and variety of available therapies for Crohn's disease, many patients do not respond adequately to treatment or they develop severe side effects from the medicines. Therefore, new treatments must be developed. J695 is an antibody that is identical to a human antibody but chemically changed so that it can attach to and eliminate an inflammatory chemical made by the body called interleukin-12 (IL-12). Animal studies have shown that eliminating IL-12 with an antibody can prevent inflammation in the gut and can also heal inflammation that has already developed. Patients 18 years of age and older who have had Crohn's disease for at least 4 months may be eligible for this study. Candidates will be screened with a medical history and physical examination, electrocardiogram, chest X-ray, blood and urine tests, stool analysis and possibly a review of medical records. They will complete a Crohn's Disease Activity Index Questionnaire for 7 days. Participants will be randomly assigned to one of two treatment groups, as follows: Group 1 Patients in this group will receive an injection of either J695 or placebo (a solution that does not contain any active medicine) under the skin on day 1 of the study, on day 29, and then weekly for a total of seven injections. After the last injection, patients will be followed for an additional 18 weeks. They will be monitored periodically throughout the study with physical examinations, disease activity index scores, and blood and urine tests. Group 2 Patients in group 2 will receive an injection of J695 or placebo on day 1 of the study and then weekly for a total of six injections. They will be followed for an additional 18 weeks. Patients will be monitored as described above for group 1. Participants may be asked to undergo additional tests as part of a sub-study in this protocol. These include colonoscopies to examine changes in inflammation in the gut and blood tests to analyze changes in the cells and body chemicals that affect the inflammation.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Sulfasalazine

Condition Name

Condition Name for Sulfasalazine
Intervention Trials
Rheumatoid Arthritis 15
Arthritis, Rheumatoid 6
Ulcerative Colitis 5
Ankylosing Spondylitis 5
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Condition MeSH

Condition MeSH for Sulfasalazine
Intervention Trials
Arthritis 26
Arthritis, Rheumatoid 21
Spondylitis, Ankylosing 8
Spondylitis 7
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Clinical Trial Locations for Sulfasalazine

Trials by Country

Trials by Country for Sulfasalazine
Location Trials
United States 160
Canada 16
Spain 10
China 5
Germany 5
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Trials by US State

Trials by US State for Sulfasalazine
Location Trials
Massachusetts 8
Maryland 8
California 7
Texas 6
Ohio 6
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Clinical Trial Progress for Sulfasalazine

Clinical Trial Phase

Clinical Trial Phase for Sulfasalazine
Clinical Trial Phase Trials
Phase 4 17
Phase 3 12
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Sulfasalazine
Clinical Trial Phase Trials
Completed 36
Recruiting 10
Not yet recruiting 6
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Clinical Trial Sponsors for Sulfasalazine

Sponsor Name

Sponsor Name for Sulfasalazine
Sponsor Trials
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) 4
Charite University, Berlin, Germany 3
Rheumatism Foundation Hospital 3
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Sponsor Type

Sponsor Type for Sulfasalazine
Sponsor Trials
Other 71
Industry 29
NIH 8
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