Crohn's Disease (CD)
Conditions
Interventions
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 mi
Sponsors
Elan Pharma Ltd.
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term tolerability of natalizumab by assessment of adverse events (AEs).;Secondary Objective: To assess immunogenicity during long-term treatment with natalizumab, as measured by anti-natalizumab antibody formation.;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. | — |
Countries
Denmark
Outcome results
None listed