Long-term Study of Semapimod (CNI-1493) for Treatment of Crohn's Disease (CD05)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00740103
First received: August 21, 2008
Last updated: August 22, 2012
Last verified: August 2012
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

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
Experimental: 1
Semapimod 60 mg IV x 3 days q 6 - 8 weeks
Drug: Semapimod
60 mg IV x 3 days q 6 - 8 weeks
Other Name: CNI-1493

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

  1. 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.
  2. 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 mesalazine 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.
  3. Patients were required to sign informed consent specifically for this study, in addition to the consent for study CNI-1493-CD-04.
  4. 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.
  5. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30342
Advanced Gastroenterology Associates
Suwanee, Georgia, United States, 30024
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, New York
Long Island Clinical Research Associates
Great Neck, New York, United States, 11021
Asher Kornbluth, MD
New York, New York, United States, 10128
Rochester General Hospital
Rochester, New York, United States, 14621
United States, Tennessee
Gastroenterology Associates
Bristol, Tennessee, United States, 37620
Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Academic Hospital Gasthuisberg
Leuven, Belgium
Germany
Benjamin Franklin University
Berlin, Germany
Medizinischen Hochschule-Hannover
Hannover, Germany
Universitats Klinikum Heidelberg
Heidelberg, Germany
University of Kiel
Kiel, Germany
Gastroenterologische Fachpraxis
Minden, Germany
University of Munster
Muenster, Germany
Stadtisches Krankenhaus Munchen-Bogenhausen
Munchen, Germany
Israel
Rambam Medical Center
Haifa, Israel
Shaare Zedek Hospital
Jerusalem, Israel
Hadassah Medical Center
Jerusalem, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Chaim Sheba Medical Center
Tel Hashomer, Israel
Netherlands
Free University (Vrije Universiteit)
Amsterdam, Netherlands
Academic Medical Center
Amsterdam, Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Principal Investigator: Daan Hommes, MD Academic Medical Center, Netherlands
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00740103     History of Changes
Other Study ID Numbers: CNI-1493-CD05
Study First Received: August 21, 2008
Last Updated: August 22, 2012
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 Ferring Pharmaceuticals:
Semapimod
Crohn's Disease
TNF-alpha inhibitor
MAP Kinase inhibitor
CNI-1493

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Semapimod
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 27, 2014