A Phase III, Multicenter, Open-Label, Long-Term Study of the Tolerability of Intravenous Natalizumab in Crohn's Disease Subjects Who Have Previously Participated in Natalizumab Crohn's Disease Study CD351 - CD354

• Conditions: Crohn's Disease (CD)

• Registration Number: EUCTR2004-003839-31-DK
• Lead Sponsor: Elan Pharma Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

- Subjects must have provided written informed consent;

- Subjects must be =18 years of age;

- Subjects must either be currently participating in natalizumab Crohn's Disease Study CD351 or have completed their 24th infusion in the CD351 study within the previous 12 weeks.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Women of childbearing potential unless surgically sterile or using adequate contraception (either IUD, oral or depot contraceptive, or barrier plus spermicide), and willing and able to continue contraception for at least 3 months after administration of the last infusion of study drug;

- Women who are pregnant or breastfeeding;

- Subjects who have experienced any anaphylaxis, angioedema, urticaria, clinical syndrome diagnostic of serum sickness, or biopsy-proven vasculitis to a previous infusion of natalizumab.

- Subjects whose concomitant medication for CD include any of the following:

Use of Infliximab (except for subjects previously enrolled in Study CD306 who are currently receiving infliximab in CD351).

Use of tacrolimus, cyclosporin, mycophenolate mofetil or any experimental CD therapy where these agents have not been discontinued for at least 4 weeks prior to month 0.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified