Status:
COMPLETED
Long-term Study of Semapimod (CNI-1493) for Treatment of Crohn's Disease
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief 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 ass...
Detailed 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 ass...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients satisfactorily completing study CNI-1493-04 were eligible for participation in this study. Satisfactory completion was defined as follows:
- 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.
- The patient received at least 2 of the 3 planned doses of study medication.
- The patient had no adverse event \>grade 2 felt to be possibly, probably or definitely related to study medication.
- 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.
- At baseline for study CNI-1493-CD-05, patients were to meet the same concomitant medication criteria as for study CNI-1493-CD-04:
- 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
- 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.
- Patients were required to sign informed consent specifically for this study, in addition to the consent for study CNI-1493-CD-04.
- 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.
- Patients were to be able to adhere to the study visit schedule and/or protocol requirements.
Exclusion
- Only patients completing CD04 were eligible and must not have met any of the exclusion criteria for that study.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT00740103
Start Date
December 1 2002
End Date
September 1 2004
Last Update
March 28 2025
Active Locations (26)
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1
University of California, San Francisco
San Francisco, California, United States, 94115
2
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30342
3
Advanced Gastroenterology Associates
Suwanee, Georgia, United States, 30024
4
Northwestern University
Chicago, Illinois, United States, 60611