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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
History of Changes

August 22, 2008
August 22, 2012
July 2003
June 2006   (final data collection date for primary outcome measure)
Crohn's Disease Activity Index (CDAI) [ Time Frame: Every 6 - 10 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00741910 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: Every 6 - 10 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Extension Study of Semapimod 60 mg IV x 3 Days
Extension Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease

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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Crohn's Disease
Drug: Semapimod
semapimod IV 60 mg x 3 days q 6 - 10 weeks
Other Name: CNI-1493
Experimental: 1
Semapimod 60 mg IV q 6 - 10 weeks
Intervention: Drug: Semapimod
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
June 2006
June 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Israel,   Netherlands
 
NCT00741910
CNI-1493-CD06
No
Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Principal Investigator: Daan Hommes, MD Academic Medical Center, Netherlands
Ferring Pharmaceuticals
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP