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

Korábbi kezelés

• 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 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.

Más betegség

• Patients who developed an anaphylactic or severe allergic reaction to study medication during REScUE.

Laborértékek

• 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

Egyéb

• 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.

• 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.