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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR PENTASA

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Clinical Trials for Pentasa

Trial ID Title Status Sponsor Phase Summary
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.
NCT00094458 Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na�ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONIC Completed Schering-Plough Phase 3 The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's Disease (5-ASA) and corticosteroids. Patients will receive either infliximab (a drug used to treat autoimmune diseases) or azathioprine (an immunosuppressant or drug used to suppress the immune system) or a combination of both for up to 34 weeks. This research study will involve approximately 500 patients. The main study involves up to 34 weeks (approximately 8 months). A study extension of an additional 20 weeks (approximately 5 months) is optional for patients who successfully complete the main study. A country-specific study extension of open label infliximab treatment for an additional 1 year is optional for patients who successfully complete the main study extension.
NCT00094458 Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na�ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONIC Completed Centocor Ortho Biotech Services, L.L.C. Phase 3 The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's Disease (5-ASA) and corticosteroids. Patients will receive either infliximab (a drug used to treat autoimmune diseases) or azathioprine (an immunosuppressant or drug used to suppress the immune system) or a combination of both for up to 34 weeks. This research study will involve approximately 500 patients. The main study involves up to 34 weeks (approximately 8 months). A study extension of an additional 20 weeks (approximately 5 months) is optional for patients who successfully complete the main study. A country-specific study extension of open label infliximab treatment for an additional 1 year is optional for patients who successfully complete the main study extension.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Pentasa

Condition Name

Condition Name for Pentasa
Intervention Trials
Ulcerative Colitis 7
Crohn's Disease 5
Crohn Disease 2
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Condition MeSH

Condition MeSH for Pentasa
Intervention Trials
Ulcer 11
Colitis, Ulcerative 10
Colitis 10
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Clinical Trial Locations for Pentasa

Trials by Country

Trials by Country for Pentasa
Location Trials
United States 78
Canada 15
France 5
Netherlands 5
Belgium 5
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Trials by US State

Trials by US State for Pentasa
Location Trials
California 5
Florida 4
North Carolina 4
Ohio 3
Pennsylvania 3
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Clinical Trial Progress for Pentasa

Clinical Trial Phase

Clinical Trial Phase for Pentasa
Clinical Trial Phase Trials
Phase 4 5
Phase 3 9
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Pentasa
Clinical Trial Phase Trials
Completed 9
Recruiting 6
Terminated 3
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Clinical Trial Sponsors for Pentasa

Sponsor Name

Sponsor Name for Pentasa
Sponsor Trials
Ferring Pharmaceuticals 9
Sheba Medical Center 1
VU University Medical Center 1
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Sponsor Type

Sponsor Type for Pentasa
Sponsor Trials
Industry 13
Other 7
NIH 2
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