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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-003839-31-DK
• Date of registration: 17/05/2005
• Prospective Registration: No
• Primary sponsor: Elan Pharma Ltd.
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 05/02/2005
• Target sample size: 1000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-003839-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Denmark

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Crohn's Disease (CD)

Intervention(s)

Product Name: natalizumab
Product Code: AN100226
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: natalizumab
Current Sponsor code: AN100226
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Main Objective: To evaluate the long-term tolerability of natalizumab by assessment of adverse events (AEs).

Primary end point(s): The primary objective of this study is to evaluate the long-term tolerability of natalizumab when administered at a dose of 300 mg IV to subjects with Crohn's Disease who have participated in natalizumab study CD351.

Secondary Objective: To assess immunogenicity during long-term treatment with natalizumab, as measured by anti-natalizumab antibody formation.

Secondary ID(s)

ELN100226-CD354