UC, ulcerative colitis, IBD, golimumab, SIMPONI
Conditions
Interventions
2 short questionnaires to be completed at home in number of stools and the presence of blood in the stool is reported (once per 4 wks for the first year)
- Complete a short questionnaire at home abou
Sponsors
MSD B.V.
Eligibility
Inclusion criteria
Inclusion criteria: - Adult age - Established diagnosis of UC since at least 3 months - Moderately-to-severely active UC eligible for SIMPONI treatment according to the European SmPC - Active disease at SIMPONI treatment initiation with a Mayo score ≥ 6 and endoscopic sub-score ≥ 2. - Naïve to anti-TNF therapy or exposed to no more than one anti-TNF (excluding SIMPONI) and not considered a primary non-responder to the first anti-TNF, or exposed to no more than one other non-anti-TNF biological therapy including anti-integrin antibodies (approved or investigational) and JAK inhibitors (approved or investigational)
Exclusion criteria
Exclusion criteria: - Child or adolescent age. - Contraindication to anti-TNF therapy according to drug labelling: active infection, non-treated latent tuberculosis, congestive heart failure (NYHA: Grade III and IV), malignancy during the previous 5 years (except non-melanoma skin cancer), demyelinating neurological disease. - People unable to give their consent (because of their physical or mental state). - Pregnancy or breastfeeding. - Patients with severe acute colitis or patients at imminent risk for colectomy. - History of (partial) colectomy. - Patients with stoma or Ileal Pouch Anal Anastomosis (IPAA) - Proctitis (<20 cm) - History of colonic mucosal dysplasia or adenomatous colonic polyps that are not removed. - Screening stool study positive for enteric pathogens or Clostridium difficile toxin. - Currently on SIMPONI treatment or previously treated with SIMPONI - Primary non-response to a previous anti-TNF therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of UC patients with patient-reported Continuous Clinical Response (pCCR) to golimumab (SIMPONI) after induction (at week 6, 10 or14) through week 54 based on stool frequency and rectal bleeding score (PRO2) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change of PRO2 score from baseline at week 6, 10 or14 and at week 54 and 108. - Proportion of patients in remission and in corticosteroid-free remission at week 54 and 108. - Proportion of patients with UC-related hospitalization through week 54 and 108. - Proportion of patients with UC-related surgery through week 54 and 108. - Change of patient-reported QoL based on SHS from week 0 at week 12 (6-14), 30, 54, 78 and 108. Other pre-specified analyses will include: - Analysis of the primary and major secondary endpoints in the subgroups of patients previously exposed to anti-TNF or other biologics and the subgroup of biologic-naïve patients. - Change of stool frequency score from baseline to week 6, 10 or14 and through week 54 and 108. Stool frequency score is a component of PRO2. - Change of rectal bleeding score from baseline to week 6, 10 or 14 and at week 54 and 108. Rectal bleeding score is a component of PRO2. - Change of patient-reported work productivity based on WPAI:UC from week 0, at week, 30, 54, 78, and 108 - Proportion of patients with loss of response to 50 or 100 mg SIMPONI maintenance treatment through week 54 and 108. - Change of fecal calprotectin level from baseline to week 30, 54, 78, and 108 (in those centers where fecal calprotectin measurement is adopted in clinical practice) | — |
Contacts
Public ContactM. Pierik
Outcome results
None listed