|- candidate number||26515|
|- NTR Number||NTR6351|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-jan-2017|
|- Secondary IDs||2017-MK8259-052 |
|- Public Title||GO OBSERVE: A European observational study in adults with moderate to severe ulcerative colitis in which the patient reports his or her response to SIMPONI at home through a website.|
|- Scientific Title||European Prospective Observational Cohort Study of Patient-reported Continuous Clinical Response to golimumab (SIMPONI) in adults with moderate to severely active Ulcerative Colitis (GO OBSERVE)|
|- ACRONYM||GO OBSERVE|
|- hypothesis||Remote patient reported outcome measures (replacing partial Mayo) can be used for monitoring continuous clinical control of UC disease|
|- Healt Condition(s) or Problem(s) studied||Ulcerative colitis, IBD|
|- 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.
- Na´ve 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||- 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
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||9-feb-2017|
|- planned closingdate||16-feb-2021|
|- Target number of participants||33|
|- 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 about the quality of your life (3 times per year during the 2-year study period)
- Complete a short questionnaire at home about work and physical activity (3 times per year during the 2-year study period)
Answers can be send using the internet or complete the questionnaires using an application on smartphone or mobile device
|- Primary outcome||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 outcome||- 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-na´ve 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)
|- Timepoints||PRO2 every 4 wks until week 108|
SHS/WPAI wk 0, end of induction (wk 6,10 or 14), 30, 54, 78, 108
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| M. Pierik|
|- CONTACT for SCIENTIFIC QUERIES|| M. Pierik|
|- Sponsor/Initiator ||MSD B.V.|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background: Good quality of life with normalization of bowel habits, resolution of rectal bleeding, and mucosal healing are key treatment targets in ulcerative colitis (UC). Continuous control of UC disease activity with mucosal healing may be the best way to change the course of UC. Efficacy and safety of subcutaneous golimumab 50mg and 100mg versus placebo for moderate to severe UC was established in the PURSUIT-M trial. The primary endpoint of PURSUIT-M was continuous control of UC disease activity measured by partial Mayo score every 4 weeks (q4wk) and by Mayo score (including endoscopy) at weeks 30 and 54. Patients achieving this endpoint were thus in continuous clinical response (CCR) through 54 weeks.|
Purpose: This CCR endpoint of PURUIT-M is not a practical outcome measure in routine UC clinical management. Patients are not seen nor assessed for UC symptoms by the physician every 4 weeks in practice. Therefore, the main purpose of this study is to investigate if remote patient reported outcome measures (replacing partial Mayo) can be used for continuous clinical control of UC disease.
In addition, fecal calprotectine - if used according to standard practice - can be used as a reliable marker of mucosal inflammation in UC. This may lead to a reduced need for endoscopies. Therefore, this study will also assess if patient reported outcome together with fecal calprotectine can be used for tight disease control in real-life clinical practice.
Motivation: Tight disease control may lead to achieving normal QoL which is a major goal of GO OBSERVE. It may also result in less hospitalizations, less surgery and less need for comedication. (i.e. change the course of the disease)
|- Main changes (audit trail)|
|- RECORD||20-jan-2017 - 1-jun-2017|