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Sponsored by: |
Cytokine PharmaSciences |
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Information provided by: | Cytokine PharmaSciences |
ClinicalTrials.gov Identifier: | NCT00740103 |
CNI-1493-CD05 is an open-label extension study of CNI-1493-CD04. In the CD05 study, patients are eligible for up to 5 courses of semapimod 60 mg IV x 3 days every 6 - 8 weeks. Primary objective is assessment of the efficacy of cumulative doses of semapimod measured by decrease in Crohn's Disease Activity Index (CDAI).
Condition | Intervention | Phase |
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Crohn's Disease |
Drug: Semapimod |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Long-Term Study of Semapimod (CNI-1493) for Treatment of Moderate to Severe Crohn's Disease With Reference to Study CNI-1493-CD-04, 1 or 3 Days' Treatment vs. Placebo |
Enrollment: | 119 |
Study Start Date: | December 2002 |
Study Completion Date: | September 2004 |
Primary Completion Date: | July 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Semapimod 60 mg IV x 3 days q 6 - 8 weeks
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Drug: Semapimod
60 mg IV x 3 days q 6 - 8 weeks
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CNI-1493-CD05 is an open-label extension study of CNI-1493-CD04. In the CD05 study, patients are eligible for up to 5 courses of semapimod 60 mg IV x 3 days every 6 - 8 weeks. Primary objective is assessment of the efficacy of cumulative doses of semapimod measured by decrease in Crohn's Disease Activity Index (CDAI). In addition, the safety of repeated courses was measured by recording adverse events over time.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion Criteria
Patients satisfactorily completing study CNI-1493-04 were eligible for participation in this study. Satisfactory completion was defined as follows:
At baseline for study CNI-1493-CD-05, patients were to meet the same concomitant medication criteria as for study CNI-1493-CD-04:
Patients receiving medications for CD were to be on each medication for at least 8 weeks prior to screening and on stable doses of each for at least 2 weeks prior to baseline assessments, with the following exceptions:
Exclusion Criteria:
Only patients completing CD04 were eligible and must not have met any of the exclusion criteria for that study.
United States, California | |
University of California, San Francisco | |
San Francisco, California, United States, 94115 | |
United States, Georgia | |
Advanced Gastroenterology Associates | |
Suwanee, Georgia, United States, 30024 | |
Atlanta Gastroenterology Associates | |
Atlanta, Georgia, United States, 30342 | |
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 | |
United States, New York | |
Asher Kornbluth, MD | |
New York, New York, United States, 10128 | |
Long Island Clinical Research Associates | |
Great Neck, New York, United States, 11021 | |
Rochester General Hospital | |
Rochester, New York, United States, 14621 | |
United States, Tennessee | |
Gastroenterology Associates | |
Bristol, Tennessee, United States, 37620 | |
Belgium | |
Academic Hospital Gasthuisberg | |
Leuven, Belgium | |
Cliniques Universitaires Saint-Luc | |
Brussels, Belgium | |
Germany | |
Medizinischen Hochschule-Hannover | |
Hannover, Germany | |
Gastroenterologische Fachpraxis | |
Minden, Germany | |
Benjamin Franklin University | |
Berlin, Germany | |
Stadtisches Krankenhaus Munchen-Bogenhausen | |
Munchen, Germany | |
Universitats Klinikum Heidelberg | |
Heidelberg, Germany | |
University of Kiel | |
Kiel, Germany | |
University of Munster | |
Muenster, Germany | |
Israel | |
Rambam Medical Center | |
Haifa, Israel | |
Hadassah Medical Center | |
Jerusalem, Israel | |
Chaim Sheba Medical Center | |
Tel Hashomer, Israel | |
Shaare Zedek Hospital | |
Jerusalem, Israel | |
Tel Aviv Sourasky Medical Center | |
Tel Aviv, Israel | |
Netherlands | |
Academic Medical Center | |
Amsterdam, Netherlands | |
Academisch Ziekenhuis Maastricht | |
Maastricht, Netherlands | |
Erasmus Medical Center | |
Rotterdam, Netherlands | |
Free University (Vrije Universiteit) | |
Amsterdam, Netherlands |
Principal Investigator: | Daan Hommes, MD | Academic Medical Center, Netherlands |
Responsible Party: | Cytokine PharmaSciences., Inc. ( Barbara Powers/Vice President, Clinical Development ) |
Study ID Numbers: | CNI-1493-CD05 |
Study First Received: | August 21, 2008 |
Last Updated: | August 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00740103 |
Health Authority: | United States: Food and Drug Administration; Belgium: Institutional Review Board; Germany: Ministry of Health; Israel: Ethics Commission; Netherlands: Medical Ethics Review Committee (METC) |
Semapimod Crohn's Disease TNF-alpha inhibitor MAP Kinase inhibitor CNI-1493 |
Digestive System Diseases Gastrointestinal Diseases Crohn Disease Inflammatory Bowel Diseases |
Gastroenteritis Intestinal Diseases CNI 1493 |
Anti-Inflammatory Agents Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions Analgesics, Non-Narcotic Sensory System Agents |
Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |