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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00741910
First received: August 22, 2008
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

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 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: Extension Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease

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 - 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: Every 6 - 10 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: July 2003
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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.

  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: NCT00741910

Locations
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
Germany
Benjamin Franklin University
Berlin, Germany
Israel
Rambam Medical Center
Haifa, Israel
Shaare Zedek Hospital
Jerusalem, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
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: NCT00741910     History of Changes
Other Study ID Numbers: CNI-1493-CD06
Study First Received: August 22, 2008
Last Updated: August 22, 2012
Health Authority: United States: Food and Drug Administration
Israel: Ethics Commission
Germany: Ethics Commission
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Ferring Pharmaceuticals:
Crohn's Disease
TNF-alpha inhibitor
MAP Kinase inhibitor
CNI-1493

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

ClinicalTrials.gov processed this record on October 21, 2014