Extension Study of Semapimod 60 mg IV x 3 Days

Overview

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.

Full Title of Study: “Extension Study of CNI-1493 for Treatment of Moderate to Severe Crohn’s Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2006

Interventions

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

Arms, Groups and Cohorts

  • Experimental: 1
    • Semapimod 60 mg IV q 6 – 10 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Crohn’s Disease Activity Index (CDAI)
    • Time Frame: Every 6 – 10 weeks

Secondary Measures

  • Safety
    • Time Frame: Every 6 – 10 weeks

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ferring Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Daan Hommes, MD, Principal Investigator, Academic Medical Center, Netherlands

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