Crohn’s disease
Conditions
Interventions
Trade Name: Stelara 45 mg solution for injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ustekinumab
CAS Number: 815610-63-0
Other descriptive name: USTEKINUMAB
Concentration
Sponsors
Belgian IBD research and development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. =18 years 2. Diagnosis of Crohn’s disease for at least 3 months prior to visit 1 by endoscopic and/or radiologic examination. 3. Patient currently treated with UST, independent of previous biological exposure. 4. Patients treated with maintenance UST SC 90 mg Q8W (meaning after a minimum of 2 SC injections) 5. Documented primary response at any time point during induction (up to week 20) defined as a clinical response (physician discretion) AND confirmed by either any of the following: 1. A documented decrease in biomarkers based on a value during induction period compared to a value prior to UST induction (max. 3 months prior to start of UST induction) a. A decrease in CRP OR b. A decrease in FCP 2. A documented endoscopic improvement (evaluation during the induction period compared to an evaluation prior to UST induction (max. 6 months prior to start of UST induction) 6. Documented loss of response after induction (> week 16) assessed by the physician as moderate to severe active Crohn’s disease. The increase in symptoms reported by the patient is defined as: PRO-2 (AP > 1 AND SF > 3) AND confirmed by either any of the following: 1. Documentation of endoscopic lesions in at least one segment of the ileum or colon as assessed by ileocolonoscopy AND a documented increase in biomarkers based on an increased value compared to the lowest value obtained during induction or after week 16 UST induction. a. An increase in CRP and >5 mg/L OR b. An increase in FCP and > 250µg/mg 2. A documented relapse on endoscopy: Presence of mucosal ulcers in at least one segment of the ileum or colon and a SES-CD = 6 (for patients with isolated ileitis =4), as assessed by ileocolonoscopy 7. Adequate contraception in female of reproductive age (oral contraception, intra uterine device, sterilisation or barrier method) 8. Have the capacity to understand and sign an informed consent form. 9. Be able to adhere to the study visit schedule and other protocol requirements. 10. All Crohn's Disease treatments stable for at least 2 weeks prior to baseline Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 108 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Ongoing treatment with a. other concomitant biological (vedolizumab, anti-TNF) b. Steroids >20 mg prednisolone or equivalent at baseline (budesonide >6 mg; >5 mg beclomethasone dipropionate at baseline) c. Q4w ustekinumab 2. Women that are pregnant, nursing, or planning pregnancy 3. Have current signs or symptoms of infection confirmed by positive stool or blood testing (including gastrointestinal pathogens, TB, HIV, Hep B, Hep C). 4. Patients with a positive stool sample for gastrointestinal pathogen including Clostridium difficile. 5. Patients with an impassable stenosis even after attempt of endoscopic balloon dilation. 6. Patients with an abscess
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess the clinical effect of ustekinumab re-induction ˜6mg/kg IV followed by either 90 mg SC Q8W or 90 mg SC Q4W in patients with CD who show a secondary loss of response over time;Secondary Objective: to assess the endoscopic and biochemical effects of, pharmacodynamic and pharmacokinetic aspects of, quality of life of patients treated with, asses safety and socio-economic impact of ustekinumab re-induction ˜6mg/kg IV followed by either 90 mg SC Q8W or Q4W in patients with CD who show a secondary loss of response over time;Primary end point(s): Proportion of patients with steroid free clinical remission (PRO-2 remission: AP = 1 AND SF = 3) and FCP <250µg/g.;Timepoint(s) of evaluation of this end point: week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of patients with complete endoscopic remission (SES-CD 1.4 µg/mL ;Timepoint(s) of evaluation of this end point: week 48 at week 8 after IV re-induction at all timepoints of the study corresponding to each studyvisit ( week 4, 8, 12, 20, 28, 36, 44 and 48) | — |
Countries
Belgium
Contacts
Public ContactChief operating officer
Belgian IBD research and development
Outcome results
None listed