Extension Study of Semapimod 60 mg IV x 3 Days

Crohn's Disease Clinical Trial

— CD06  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741910
• Other study ID #: CNI-1493-CD06
• Status: Completed
• Phase: Phase 2
• Start date: July 2003
• Est. completion date: June 2006

Study information

• Verified date: August 2012
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Semapimod
semapimod IV 60 mg x 3 days q 6 - 10 weeks

Locations

Country	Name	City	State
Germany	Benjamin Franklin University	Berlin
Israel	Rambam Medical Center	Haifa
Israel	Shaare Zedek Hospital	Jerusalem
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Netherlands	Erasmus Medical Center	Rotterdam
United States	Northwestern University	Chicago	Illinois
United States	Long Island Clinical Research Associates	Great Neck	New York
United States	Asher Kornbluth, MD	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany,  Israel,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crohn's Disease Activity Index (CDAI)		Every 6 - 10 weeks
Secondary	Safety		Every 6 - 10 weeks