Extension Study of Semapimod 60 mg IV x 3 Days (CD06)
This study has been completed.
Information provided by (Responsible Party):
First received: August 22, 2008
Last updated: August 22, 2012
Last verified: August 2012
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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Extension Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2006 (Final data collection date for primary outcome measure)
Semapimod 60 mg IV q 6 - 10 weeks
semapimod IV 60 mg x 3 days q 6 - 10 weeks
Other Name: CNI-1493
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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:
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:
- The patient completed 5 treatment courses in the previous trial.
- 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.
- The patient had no adverse event >grade 2 felt to be probably or definitely related to study medication.
- The patient did not meet any discontinuation criterion in previous trial.
- 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.
- Patients could not take any other investigational therapies during the course of this study.
- 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.
- Patients had to be able to adhere to the study visit schedule and/or protocol requirements.
Could not have met any of the exclusion criteria for the CD02, 03, 04 or 05 studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741910
|Chicago, Illinois, United States, 60611 |
|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 |
||Daan Hommes, MD
||Academic Medical Center, Netherlands
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 22, 2008
||August 22, 2012
||United States: Food and Drug Administration
Israel: Ethics Commission
Germany: Ethics Commission
Netherlands: Medical Ethics Review Committee (METC)
Keywords provided by Ferring Pharmaceuticals:
MAP Kinase inhibitor
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Inflammatory Bowel Diseases
Digestive System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents