Crohn's Disease
Conditions
Keywords
Crohn's Disease, TNF-alpha inhibitor, MAP Kinase inhibitor, CNI-1493
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.
Interventions
DRUGSemapimod
semapimod IV 60 mg x 3 days q 6 - 10 weeks
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Crohn's Disease Activity Index (CDAI) | Every 6 - 10 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Safety | Every 6 - 10 weeks |
Countries
Germany, Israel, Netherlands, United States
Outcome results
None listed