Moderate to severe ulcerative colitis
Conditions
Interventions
Trade Name: SIMPONI 50 mg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Other descriptive name: SIMPONI
Concentration unit: mg milligram(s)
Concent
Sponsors
GETAID
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age = 18 years and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Age under 18 and over 75. - People unable to give their consent (because of their physical or mental state). - Absence of written consent. - Pregnancy or breastfeeding. - Patients with severe acute colitis or patients at imminent risk for colectomy. - History of colectomy. - History of colonic mucosal dysplasia or adenomatous colonic polyps that are not removed. - Screening stool study positive for enteric pathogens or Clostridium difficile toxin. - Oral corticosteroids at a dose > 20 mg prednisone or its equivalent per day. - Any current or previous use of anti-TNF therapy, and other biologics, including anti-integrin antibodies (approved or investigational), JAK inhibitors (approved or investigational), or any current or previous use of an investigational agent within 5 half-lives of that agent before the first study agent injection. - Contraindication to anti-TNF therapy according to drug labelling: o Active infection. o Non-treated latent tuberculosis. o Heart failure (NYHA: Grade III and IV). o Malignancy during the previous 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the proportion of patients with Continuous Clinical Response (CCR) and endoscopic remission after one year of golumimab at week 54.;Secondary Objective: To determine the proportion of patients in CCR with MH at week 108, after discontinuation or dose de-escalation of golimumab treatment in the group of patients in CCR and with MH at week 54 Factors associated with treatment success Efficacy of dose optimization in patients who loose response between week 10 and 54 Clinical remission at week 54 and 108 Partial MAYO score at week 54 and 108 PRO2 at week 54 and 108 CCR between study inclusion and week 54 and 108 Steroid-free clinical remission at week 54 and 108 MH at week 54 and 108 Changes in faecal calprotectin levels from baseline to week 54 and 108 Colectomy between W0 and W54 and 108 UC-related hospitalizations throughout the trial Histological remission at W54 and 108 Fatigue (FACIT), disability (IBD Disability index), QoL (SHS-IBD VAS) Golimumab PK data Proportion of late responders being in Clinical Response from week 18 to week 54 and with MH at week 54 following treatment intensification in Maintenance Phase;Primary end point(s): • Week 10-54: proportion of patients in CCR and with MH (endoscopic Mayo score of 0 or 1) at week 54;Timepoint(s) of evaluation of this end point: week 10-54 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): For all included patients: • Phase II (week 54-108): proportion of patients in CCR with MH (endoscopic Mayo score of 0 or 1) at week 108, after discontinuation or dose deescalation (from 100 to 50 mg) of golimumab treatment at year 1 in the subgroup of patients in CCR and with MH (endoscopic Mayo score of 0 or 1) at week 54 • Factors associated with treatment success (see primary endpoints) • Efficacy of dose optimization in patients who loose response between week 10 and 54 • Clinical remission at week 54 • Clinical remission at week 108 • Partial MAYO score at week 54 and 108 • PRO2 (Partial Mayo minus PGA) at week 54 and 108 • CCR between study inclusion and week 54 and 108 • Steroid-free clinical remission at week 54 and 108 • MH (endoscopic score MAYO 0-1) at week 54 and 108 • Changes in faecal calprotectin levels from baseline at week 54 and 108 • Colectomy between W0 and W54 and 108 • UC-related hospitalizations throughout the trial • Histological remission at W54 and 108 Fatigue (FACIT), disability (IBD Disability index), QoL (SHS-IBD VAS) Golimumab PK data Proportion of late responders being in Clinical Response from week 18 to week 54 and with MH at week 54 following treatment intensification in Maintenance Phase;Timepoint(s) of evaluation of this end point: Week 10, 54 et 108 | — |
Countries
Belgium
Contacts
Public ContactStudy Coordinator
CHU de Liège
Outcome results
None listed