Extension Study of Semapimod 60 mg IV x 3 Days (CD06)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00741910
Recruitment Status : Completed
First Posted : August 26, 2008
Last Update Posted : August 23, 2012
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
Study CNI-1493-CD06 is an open, single-arm extension studies to CD03 and CD05. CDAI is the only efficacy measure assessed in this study. The safety of multiple courses of semapimod is to be determined by the incidence of clinical and laboratory adverse events.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Semapimod Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extension Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease
Study Start Date : July 2003
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Semapimod 60 mg IV q 6 - 10 weeks
Drug: Semapimod
semapimod IV 60 mg x 3 days q 6 - 10 weeks
Other Name: CNI-1493

Primary Outcome Measures :
  1. Crohn's Disease Activity Index (CDAI) [ Time Frame: Every 6 - 10 weeks ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: Every 6 - 10 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

The study was open to patients who had satisfactorily completed either study CNI-1493-CD-03 or CNI-1493-CD-05. Initial entry criteria were:

  1. Patients who satisfactorily completed either study CNI-1493-CD-03 or CD-05 were eligible for participation in this study. Satisfactory completion was defined as follows:

    1. The patient completed 5 treatment courses in the previous trial.
    2. The patient had responded to treatment, as defined by a decrease in CDAI of at least 70 points from original baseline (prior to treatment on study CD-02 or CD-04) at the last assessment for study CD-03 or CD-05, respectively. The decrease had to be attributable to semapimod treatment. Thus, patients whose response was attributable to other anti-Crohn's disease therapy are not to be included.
    3. The patient had no adverse event >grade 2 felt to be probably or definitely related to study medication.
    4. The patient did not meet any discontinuation criterion in previous trial.
  2. Patients had to sign informed consent specifically for this study, in addition to the consents for the previous studies, CNI-1493-CD-02 or CD-03, and CNI-1493-CD-04 or CD-05.
  3. Patients could not take any other investigational therapies during the course of this study.
  4. Men and women of childbearing potential had 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 had to be able to adhere to the study visit schedule and/or protocol requirements.

Exclusion Criteria:

Could not have met any of the exclusion criteria for the CD02, 03, 04 or 05 studies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00741910

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
Benjamin Franklin University
Berlin, Germany
Rambam Medical Center
Haifa, Israel
Shaare Zedek Hospital
Jerusalem, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Erasmus Medical Center
Rotterdam, Netherlands
Sponsors and Collaborators
Ferring Pharmaceuticals
Principal Investigator: Daan Hommes, MD Academic Medical Center, Netherlands

Responsible Party: Ferring Pharmaceuticals Identifier: NCT00741910     History of Changes
Other Study ID Numbers: CNI-1493-CD06
First Posted: August 26, 2008    Key Record Dates
Last Update Posted: August 23, 2012
Last Verified: August 2012

Keywords provided by Ferring Pharmaceuticals:
Crohn's Disease
TNF-alpha inhibitor
MAP Kinase inhibitor

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