Long-Term Study of Semapimod (CNI-1493) for Treatment of Crohn's Disease - Full Text View

Sponsored by:	Cytokine PharmaSciences
Information provided by:	Cytokine PharmaSciences
ClinicalTrials.gov Identifier:	NCT00740103

Purpose

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
Crohn's Disease	Drug: Semapimod	Phase II

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Semapimod Tumor Necrosis Factors

U.S. FDA Resources

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

Further study details as provided by Cytokine PharmaSciences:

Primary Outcome Measures:

Crohn's disease activity index (CDAI) [ Time Frame: Every 6 - 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety measured by adverse events [ Time Frame: Every 6 - 8 weeks ] [ Designated as safety issue: Yes ]

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
1: Experimental Semapimod 60 mg IV x 3 days q 6 - 8 weeks	Drug: Semapimod 60 mg IV x 3 days q 6 - 8 weeks

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Inclusion Criteria

Patients satisfactorily completing study CNI-1493-04 were eligible for participation in this study. Satisfactory completion was defined as follows:
1. The patient met all eligibility criteria for participation in study CNI-1493-04 or was granted an exemption by the medical monitor for factors indicating ineligibility.
2. The patient received at least 2 of the 3 planned doses of study medication.
3. The patient had no adverse event >grade 2 felt to be possibly, probably or definitely related to study medication.
4. The patient underwent all required evaluations, both for safety and efficacy, at baseline and day 29 and, for patients enrolling between days 43 and 57 of study CNI-1493-CD-04, at least one full later evaluation, ie the procedures required at day 43 and/or 57.
At baseline for study CNI-1493-CD-05, patients were to meet the same concomitant medication criteria as for study CNI-1493-CD-04:
1. 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:
  - those on methotrexate were to be on a stable dose for at least 4 weeks and must not be receiving more the 25mg/week
  - those on azathioprine or 6-mercaptopurine on a stable dose for at least 10 weeks
  - those on corticosteroids were to have been on them for at least 2 weeks and on a stable for those 2 weeks. They were not to be receiving more than 20 mg/day prednisone (or equivalent).
  - those on mesazaline were to have been on for at least 6 weeks and on a stable dose for at least 2 weeks
  - those on antibiotics for CD were to have been on for at least 2 weeks and on a stable dose for those 2 weeks
2. Patients who were not using other CD medications were to have stopped any previous use of these agents at least 4 weeks prior to baseline assessment for study CNI-1493-CD-05.
Patients were required to sign informed consent specifically for this study, in addition to the consent for study CNI-1493-CD-04.
Men and women of childbearing potential were to be using a barrier method (diaphragm or condom) of contraception and continue doing so for at least 3 months after last study medication. It was strongly recommended that two forms be used.
Patients were to be able to adhere to the study visit schedule and/or protocol requirements.

Exclusion Criteria:

Only patients completing CD04 were eligible and must not have met any of the exclusion criteria for that study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740103

Locations

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

Sponsors and Collaborators

Cytokine PharmaSciences

Investigators

Principal Investigator:

Daan Hommes, MD

Academic Medical Center, Netherlands

More Information

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)

Keywords provided by Cytokine PharmaSciences:

Semapimod
Crohn's Disease
TNF-alpha inhibitor
MAP Kinase inhibitor
CNI-1493

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease
Inflammatory Bowel Diseases

Gastroenteritis
Intestinal Diseases
CNI 1493

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 16, 2009