Clinical trial NCT00741910: Extension Study of Semapimod 60 mg IV x 3 Days
Official title: Extension Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Crohn's Disease
TNF-alpha inhibitor
MAP Kinase inhibitor
CNI-1493
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-08-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Crohn's Disease Activity Index (CDAI)
timeFrame: Every 6 - 10 weeks
Secondary outcomes:
measure: Safety
timeFrame: Every 6 - 10 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates
state: New York
city: New York
country: United States
facility: Asher Kornbluth, MD
state: New York
city: Berlin
country: Germany
facility: Benjamin Franklin University
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Hospital
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
affiliation: Academic Medical Center, Netherlands
name: Daan Hommes, MD
role: PRINCIPAL_INVESTIGATOR
References: