Crohn's disease and Ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Remicade
Infliximab
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg milligram(s)
Concen
Sponsors
Region Örebro län
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be included in the study, the study subject must meet the following criteria: • UC or CD diagnosed within =65 years) yes F.1.3.1 Number of subjects for this age range 36
Exclusion criteria
Exclusion criteria: Study subjects may not be included in the study if any of the following criteria are met: • A previous known diagnosis of Crohn’s disease, ulcerative colitis or IBD-U, since >6 weeks before baseline • Unable to provide informed consent • Unable to comply with protocol requirements (e.g. for reasons including alcohol and/or recreational drug abuse) • Ongoing sepsis • Acute obstructive symptoms AND evidence of a fixed stricture on radiology or colonoscopy, which suggest that the patient is in need of surgery over the following year. N.B. patients with modest degrees of stricturing on imaging but no obstructive symptoms may be included according to clinician judgement • Contra-indications to trial medications including a history of hepatitis B or C, tuberculosis, Cardiac failure, NYHA III-IV or hypersensitivity. Hypersenstitivity to a thiopurine agent should alert the prescriber to probable hypersensitivity to other thiopurines. • History of malignancy • Pregnancy • Other serious medical or psychiatric illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if a top-down treatment can improve treatment outcomes in IBD patients with a high risk of poor disease course, defined by a serum protein signature at diagnosis. ;Secondary Objective: To assess if a top-down treatment is safe and can improve quality of life and health resource allocation in IBD patients with a high risk of poor disease course, defined by a serum protein signature at diagnosis. ;Primary end point(s): Co-Primary Endpoints Proportion of subjects with corticosteroid-free clinical remission and endoscopic remission at Week 52, defined as below. Surgery because of IBD during follow-up will be defined as treatment failure. Ulcerative colitis Clinical remission per patient reported Mayo: A stool frequency subscore (SFS) = 1, and not greater than baseline, and a rectal bleeding subscore (RBS) of 0 Endoscopic remission: An endoscopic Mayo subscore of 0 (OR in patients without endoscopy at week 52, normalization of f-Calprotecin, defined as < 250µg/g (EK-Cal, Bühlmann Laboratories, Switzerland). Crohn’s disease Clinical remission: An average daily Stool Frequency (SF) = 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score = 1 and not worse than Baseline. Endoscopic remission: SES-CD=2 (OR in patients without endoscopy at week 52, normalization of f-Calprotecin, defined as < 250µg/g (EK-Cal, Bühlmann Laboratories, Switzerland). ;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Clinical remission at 52 weeks 2. Endoscopic remission at 52 weeks 3. Clinical response: Ulcerative colitis: A decrease from baseline in the adapted Mayo score by =30% or =2 points, with either a decrease from baseline in the rectal bleeding subscore =1 or an absolute rectal bleeding subscore =1 (range, 0 to 9, with higher scores indicating more severe disease). Crohn’s disease: = 30% decrease in average daily SF and/or = 30% decrease in average daily AP score and both not worse than Baseline. 4. Endoscopic response: Ulcerative colitis: An endoscopic Mayo subscore of =1 (OR in patients without endoscopy at week 52, a reduction of f-Calprotecin by =50% compared to baseline (EK-Cal, Bühlmann Laboratories, Switzerland). Crohn’s disease: decrease in SES-CD > 50% from Baseline (or for a Baseline SES-CD of 4, at least a 2 point reduction from Baseline) (OR in patients without endoscopy at week 52, a reduction of f-Calprotecin by =50% compared to baseline (EK-Cal, Bühlmann Laboratories, Switzerland). 5. The proportion of patients with drug-related adverse events 6. Time to occurrence of the first major adverse outcome, defined as the composite of surgery or hospital admission for IBD, or development of a serious disease related complication (the individual components of this outcome will also be assessed independently). Serious complications were the occurrence of substantially worsening disease activity defined by: • new abscess, fistula, or stricture among Crohn’s disease patients • progression in disease extent among ulcerative colitis patients • extra-intestinal manifestations, among patients with Crohn’s disease or ulcerative colitis 7. The cumulative glucocorticoid (measured as prednisolone equivalents) use over time through Week 52 (see appendix X for definition of prednisolone equivalents). 8. The change from baseline in CRP concentration over time through Week 52. 9. The change from baseline in faecal calprotectin concentrat | — |
Countries
Denmark, Iceland
Contacts
Public ContactDept of Internal Medicine
Region Örebro län
Outcome results
None listed