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

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.