Study to Evaluate Long Term Effect,Safety & Tolerability of Adalimumab
Research type
Research Study
Full title
A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease
IRAS ID
162581
Contact name
Daniel Kreeb
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2013-004034-15
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
This clinical trial is planned to evaluate the long-term effectiveness, safety, and tolerability of repeated administration of adalimumab in participants with Crohn's Disease who have participated in and successfully completed the precedent study M14-115. The precedent study compared a high dose adalimumab induction regime with the normal induction regime. We are also going to assess how a body processes adalimumab (pharmacokinetics) and the interaction between adalimumab and the participants’ immune system (immunogenicity) when adalimumab is given as a subcutaneous injection.
It is expected about 300 participants will be rollover from the precedent study to this extension study. At the final visit of precedent study, participants will be evaluated to see whether they are eligible to take part in this extension study. If the participants are eligible and if they decide to take part, the visit will be considered as the first visit (Week 0, Baseline) of the extension study.
All participants will receive adalimumab 40mg every other week for up to 40 weeks. The dose can be escalated to 40 mg every week if the participant doesn't show desired response after Week 2.
Study visits will be performed at Weeks 0, 8, 16, 24, 32 and 40 or Premature Discontinuation. All participants will be provided a paper participant diary in which they will record Crohn's Disease-related symptoms. Blood samples will be collected at various time points. Stool samples will be collected as well.
Following discontinuation of the study drug, the subject will be treated in accordance with the Investigator's best clinical judgment. A final phone call will be made to the participants approximately 70 days after the last dose of study drug for their safety. The follow-up phone call will not be required for any participants started to take adalimumab as part of their normal clinical care outside the study.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
14/EE/1185
Date of REC Opinion
27 Jan 2015
REC opinion
Further Information Favourable Opinion