Long-term Study of Semapimod (CNI-1493) for Treatment of Crohn's Disease

Crohn's Disease Clinical Trial

— CD05  

Official title:

Long-term Study of Semapimod (CNI-1493) for Treatment of Moderate to Severe Crohn's Disease With Reference to Study CNI-1493-CD-04, 1 or 3 Days' Treatment vs. Placebo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00740103
• Other study ID #: CNI-1493-CD05
• Status: Completed
• Phase: Phase 2
• First received: August 21, 2008
• Last updated: August 22, 2012
• Start date: December 2002
• Est. completion date: September 2004

Study information

• Verified date: August 2012
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Institutional Review BoardGermany: Ministry of HealthIsrael: Ethics CommissionNetherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

CNI-1493-CD05 is an open-label extension study of CNI-1493-CD04. In the CD05 study, patients are eligible for up to 5 courses of semapimod 60 mg IV x 3 days every 6 - 8 weeks. Primary objective is assessment of the efficacy of cumulative doses of semapimod measured by decrease in Crohn's Disease Activity Index (CDAI).

Description:

CNI-1493-CD05 is an open-label extension study of CNI-1493-CD04. In the CD05 study, patients are eligible for up to 5 courses of semapimod 60 mg IV x 3 days every 6 - 8 weeks. Primary objective is assessment of the efficacy of cumulative doses of semapimod measured by decrease in Crohn's Disease Activity Index (CDAI). In addition, the safety of repeated courses was measured by recording adverse events over time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: September 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Inclusion Criteria

1. Patients satisfactorily completing study CNI-1493-04 were eligible for participation in this study. Satisfactory completion was defined as follows:

1. The patient met all eligibility criteria for participation in study CNI-1493-04 or was granted an exemption by the medical monitor for factors indicating ineligibility.

2. The patient received at least 2 of the 3 planned doses of study medication.

3. The patient had no adverse event >grade 2 felt to be possibly, probably or definitely related to study medication.

4. The patient underwent all required evaluations, both for safety and efficacy, at baseline and day 29 and, for patients enrolling between days 43 and 57 of study CNI-1493-CD-04, at least one full later evaluation, ie the procedures required at day 43 and/or 57.

2. At baseline for study CNI-1493-CD-05, patients were to meet the same concomitant medication criteria as for study CNI-1493-CD-04:

1. Patients receiving medications for CD were to be on each medication for at least 8 weeks prior to screening and on stable doses of each for at least 2 weeks prior to baseline assessments, with the following exceptions:

• those on methotrexate were to be on a stable dose for at least 4 weeks and must not be receiving more the 25mg/week

• those on azathioprine or 6-mercaptopurine on a stable dose for at least 10 weeks

• those on corticosteroids were to have been on them for at least 2 weeks and on a stable for those 2 weeks. They were not to be receiving more than 20 mg/day prednisone (or equivalent).

• those on mesalazine were to have been on for at least 6 weeks and on a stable dose for at least 2 weeks

• those on antibiotics for CD were to have been on for at least 2 weeks and on a stable dose for those 2 weeks

2. Patients who were not using other CD medications were to have stopped any previous use of these agents at least 4 weeks prior to baseline assessment for study CNI-1493-CD-05.

3. Patients were required to sign informed consent specifically for this study, in addition to the consent for study CNI-1493-CD-04.

4. Men and women of childbearing potential were 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 were to be able to adhere to the study visit schedule and/or protocol requirements.

Exclusion Criteria:

Only patients completing CD04 were eligible and must not have met any of the exclusion criteria for that study.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Semapimod
60 mg IV x 3 days q 6 - 8 weeks

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	Academic Hospital Gasthuisberg	Leuven
Germany	Benjamin Franklin University	Berlin
Germany	Medizinischen Hochschule-Hannover	Hannover
Germany	Universitats Klinikum Heidelberg	Heidelberg
Germany	University of Kiel	Kiel
Germany	Gastroenterologische Fachpraxis	Minden
Germany	University of Munster	Muenster
Germany	Stadtisches Krankenhaus Munchen-Bogenhausen	Munchen
Israel	Rambam Medical Center	Haifa
Israel	Hadassah Medical Center	Jerusalem
Israel	Shaare Zedek Hospital	Jerusalem
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Israel	Chaim Sheba Medical Center	Tel Hashomer
Netherlands	Academic Medical Center	Amsterdam
Netherlands	Free University (Vrije Universiteit)	Amsterdam
Netherlands	Academisch Ziekenhuis Maastricht	Maastricht
Netherlands	Erasmus Medical Center	Rotterdam
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Gastroenterology Associates	Bristol	Tennessee
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
United States	Rochester General Hospital	Rochester	New York
United States	University of California, San Francisco	San Francisco	California
United States	Advanced Gastroenterology Associates	Suwanee	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Israel,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crohn's disease activity index (CDAI)		Every 6 - 8 weeks	No
Secondary	Safety measured by adverse events		Every 6 - 8 weeks	Yes