Status:
ACTIVE_NOT_RECRUITING
An Open-Label Extension and Long-term Efficacy and Safety Monitoring Study of Patients with Crohn's Disease Previously Included in the Loss of RESponse to Ustekinumab Treated by Dose Escalation Study
Lead Sponsor:
Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Collaborating Sponsors:
Janssen Cilag N.V./S.A.
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The aim of the study is to assess the long-term efficacy and safety of a ustekinumab 90mg subcutaneous (SC) every 4 weeks (Q4w) regimen in patients with Crohn's disease previously enrolled in the RESc...
Detailed Description
The study is a prospective, open-label study only enrolling patients that were previously included in the REScUE study (n=max. 108; NCT04245215) and that terminated that study at week 48. Patients wil...
Eligibility Criteria
Inclusion
- Previous inclusion in the REScUE study and having reached the end of this study at week 48.
- Adequate contraception in females of reproductive age (oral, transdermal, injectable contraception, intra-uterine device, sterilisation or barrier method). Adequate contraception in males (sterilization or barrier method) if his female partner is of reproductive age.
- Have the capacity to understand and sign an informed consent form.
- Be able to adhere to the study visit schedule and other protocol requirements.
Exclusion
- Patients previously enrolled to the ustekinumab 90 mg SC Q4w-arm during REScUE who were on concomitant steroid use \>20 mg prednisone equivalents (budesonide \>6 mg; beclomethasone dipropionaat \>5 mg) at any time point in the last 28 days before the end of REScUE at week 48.
- Patients previously enrolled to the ustekinumab 90 mg SC Q4w-arm during REScUE that did not reach the following criteria at the end of REScUE at week 48:
- Clinical remission (defined as average AP\<=1 and average SF\<=3) OR clinical response (defined as a drop of at least 50% in average AP and/or a drop of at least 50% in average SF as compared to REScUE baseline, and both average AP and SF no worse than REScUE baseline) AND
- Endoscopic remission (defined as a total SES-CD \<5) OR endoscopic response (defined as a drop of at least 50% in total SES-CD score as compared to REScUE baseline)
- Patients who developed an anaphylactic or severe allergic reaction to study medication during REScUE.
- Patients with any of the following laboratory tests at W0 of the REScUE-OLE study :
- Hemoglobin level \<8.5 g/dL
- Platelets level \<100.000 /mm3
- Serum creatinine level ≥1.7 mg/dL
- AST and ALT level \>3 times the upper limit of normal range
- Direct (conjugated) bilirubin level ≥3.0 mg/dL
- Patients with an ongoing treatment with another concomitant biological (vedolizumab, anti-TNF), a JAK-inhibitor or any investigational product for the treatment of Crohn's disease at the end of REScUE at week 48.
- Patients who experience or have an ongoing infection event confirmed by positive stool or blood testing (including gastrointestinal pathogens, tuberculosis, HIV, hepatitis B, hepatitis C) should not initiate REScUE-OLE until (i) this event has completely resolved as shown by the termination of treatment with anti-infective medication, or (ii) this event is considered to be in stable remission under anti-infective medication in case of HIV, hepatitis B and hepatitis C.
- Patients with an impassable stenosis even after attempt of endoscopic balloon dilatation.
- Patients with an intra-abdominal abscess, or patients with an intra-anal abscess without adequate drainage by e.g. a seton placement.
Key Trial Info
Start Date :
September 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT05299931
Start Date
September 10 2021
End Date
June 1 2026
Last Update
February 5 2025
Active Locations (1)
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1
Ingrid Arijs
Zaventem, Belgium, 1930