An open-label, multi-center trial to examine the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have failed tapering of corticosteroids, needed corticosteroids after completion of tapering, or have successfully completed the trial C87059 (COSPAR I). - COSPAR II

CB Pharma S.A.0 sites352 target enrollmentOctober 26, 2006

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 26, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

CB Pharma S.A.

Eligibility Criteria

Inclusion Criteria

•Patients on placebo and/or active drug who were unable to complete corticosteroid tapering or who needed to be restarted on corticosteroids, and patients suffering from Crohn's disease who have successfully completed, in remission, the C87059 trial. Patients able to understand the information provided to them and who have given written informed consent for C87065\. If female, the patient is either postmenopausal for atleast one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception( oral or parenteral hormonal contraceptive; intrauterine device; barrier or spermicide\-abstinence is not an acceptable method. Patients must agree to use adequate contraception during the trial and for 12 weeks after the last dose of certolizumab. If the patient is on immunosuppresant ( azathioprine, 6\-mercaptopurine and methotrexate) are allowed immunosuppresants, the dose has to have been stable during the 8 weeks preceding and throughout the C87059 trial and is expected to remain stable during the extension trial. If the patient is on a 5\-ASA analogue for Crohn's disease, the dose has to have been stable during, and for the 4 weeks preceding, the C87059 trial and is expected to remain stable during the extension trial.
•Are the trial subjects under 18?
•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

•Subjects withdrawn or discontinued from the C87059 trial for reasons other than those listed in Inclusion 1\. Subject who received treatment other than trial medication and other than medications permitted in the C87059 trial. Subjects from countries where certolizumab pegol is authorised in Crohn's disease treatment. Patients who have developed medical conditions excluded in the C87059 trial will be excluded from participation in C87065\. Patients who took permitted antibiotics for conditions other than Crohn's disease in C87059 will be allowed to enter trial C87065 as long as the antibiotic use has not occured within two weeks of entry into C87065\.