1297.4 - BI695501 versus Humira in patients with active Crohns disease
Research type
Research Study
Full title
BI 695501 versus Humira® in patients with active Crohn’s disease: a randomized, double-blind, multicenter, parallel group, non-inferiority trial comparing efficacy, endoscopic improvement, safety, and immunogenicity
IRAS ID
214317
Contact name
Shaji Sebastian
Contact email
Sponsor organisation
Boehringer Ingelheim International GmbH
Eudract number
2016-000612-14
Duration of Study in the UK
1 years, 7 months, 12 days
Research summary
This is a trial comparing efficacy, endoscopic improvement, safety,andimmunogenicity of BI 695501 versus Humira in patients with active Crohn’s disease (CD). The trial will have a 48-week treatment period and a 10-week follow-up period in patients with moderately to severely active CD, and a primary endpoint assessment at Week 4.
The trial will consist of a Screening period of up to a maximum of 28 days, a 48-week treatment period consisting of an induction period from Baseline to Week 4 and a maintenance period from Week 5 to Week 48, and a 10-week safety follow-up period (starting after last dose of trial medication at Week 46).
Approximately 286 patients will be randomised into the trial. Patients will be randomly assigned to receive either BI 695501 or EU-approved Humira according to the randomiation ratio 1:1. Each patient will receive a loading dose of 160 mg of BI 695501 or Humira (day 1), followed by 80 mg of BI 695501 or Humira 2 weeks later (Day 15), and thereafter 40 mg of BI 695501 or Humira every 2 weeks until the end of the treatment period. Trial medication will be administered by subcutaneous injection.
At Week 4, patients will be assessed and those who are classified as responders will continue on trial and enter the maintenance phase. Patients who are originally randomized to Humira will switch to BI 695501 at Week 24. Patients will undergo up to 27 visits over the duration of the trial (56 weeks).
The primary endpoint of the trial is the proportion of patients in each treatment group with a clinical response at Week 4. The primary analysis will take place when the last patient has completed the Week 4 assessments. Patients who discontinue the trial will, at discontinuation, have an End of Treatment visit. Every effort should be made for all patients who complete the total 48-week treatment period or who discontinue the trial medication early, to return for a Safety Follow-up Visit 10 weeks after their last dose of trial medication. Patients may return for unscheduled visits should their medical condition warrant urgent attention at the discretion of the investigator.
A final analysis (including all endpoints) will be performed when all trial data are available, i.e., approximately 56 weeks after the last patient has been randomised. In this analysis, all analyses performed for the primary analysis will be repeated with the (partially) updated data, in particular with respect to safety and efficacy endpoints collected until Week 56. The results of the final analysis will be summarised in a CTR (Clinical Trial Report).REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
16/YH/0469
Date of REC Opinion
25 Jan 2017
REC opinion
Further Information Favourable Opinion