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Be Part of Research - Trial Details - A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease
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A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease

Completed

Open to: ALL

Age: 18.0 - N/A

Exeter London Southampton London Bury Cheltenham

Medical Conditions

Crohn Disease

This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


The primary purpose of this study is to evaluate the efficacy and safety of a single intravenous (IV) re-induction dose of approximately 6 milligram per kilogram (mg/kg) ustekinumab in participants with secondary loss of response (LoR) to subcutaneous (SC) every 8 Weeks (q8w) 90 mg ustekinumab maintenance therapy.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2018 Aug 2022

Publications

"Ten Bokkel Huinink S, Biemans V, Duijvestein M, Pierik M, Hoentjen F, West RL, van der Woude CJ, de Vries AC. Re-induction with intravenous Ustekinumab after secondary loss of response is a valid optimization strategy in Crohn's disease. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e783-e788. doi: 10.1097/MEG.0000000000002256."; "34334713"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Participants will receive ustekinumab approximately 6mg/kg intravenously at Week 0.

Intervention Arm Group : Group 1: Ustekinumab (IV re-induction);

Intervention Type : DRUG
Intervention Description : Participants will receive SC injection of placebo at Week 0.

Intervention Arm Group : Group 1: Ustekinumab (IV re-induction);

Intervention Type : DRUG
Intervention Description : Participants will receive IV infusion of placebo at Week 0.

Intervention Arm Group : Group 2: Ustekinumab (Continuous q8w SC maintenance);

Intervention Type : DRUG
Intervention Description : Participants will receive SC injection of ustekinumab 90 mg at Weeks 8 and 16.

Intervention Arm Group : Group 1: Ustekinumab (IV re-induction);

Intervention Type : DRUG
Intervention Description : Participants will receive SC injection of ustekinumab 90 mg at Weeks 0, 8 and 16.

Intervention Arm Group : Group 2: Ustekinumab (Continuous q8w SC maintenance);



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Devon & Exeter Hospital
    Exeter
    EX2 5DW
  • King's College Hospital NHS Foundation Trust
    London
    SE5 9RS
  • Southampton University Hospitals NHS Trust
    Southampton
    SO16 6YD
  • St George's Hospital
    London
    SW17 OQT
  • Pennine Acute Hospitals-Fairfield General Hospital
    Bury
    BL9 7TD
  • Gloucestershire Hospitals NHS Foundation Trust - Cheltenham
    Cheltenham
    GL53 7AN


The study is sponsored by Janssen-Cilag Ltd.



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Read full details for Trial ID: NCT03782376
Last updated 20 February 2024

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