Efficacy of MIrikizumab to achieve traNsmural healing in patiENTs with Crohn’s Disease : EMINENT CD

Conditions

Crohn's Disease

Brief summary

Transmural response (TR25): decrease of at least (>=) 25% of C-score in each and all active segment from baseline to week 24

Detailed description

Composite endpoint combining clinical remission and transmural response (TR25) at 6 months, Clinical remission will be defined according to PRO-2, Transmural response will be defined as a decrease of at least 25% of C-score in each active segment at baseline, Improvement or normalization of bowel urgency according to UNRS and Urgent score BU clinical meaningful improvement was defined as decrease of >=3 points, BU Remission was defined as UNRS =<2, Transmural response (TR50): decrease of at least 50% of C-score in each active segment at baseline, Transmural healing: C-score < 0.5 in each active segment at baseline/TRENCH definition, Complete transmural healing: C-score = 0 in each active segment at baseline, MaRIA at 6 months, IUS transmural response/healing at week 4,8, 12 and 24, Bowel damage (Lemann Index) at 6 and 18 months, Clinical response and remission at week 4,8, 12 and 24, Biochemical remission at week 4,8, 12 and 24, Drug retention, IBD-disability index, IBDQ, 10 points-Acceptability numerical scale (ANS), Adverse events and severe adverse events

Related papers

No related papers found yet.

Interventions

DRUGOmvoh 100 mg + 200 mg solution for injection in pre-filled pen

DRUGOmvoh 100 mg solution for injection in pre-filled pen

DRUGOmvoh 300 mg concentrate for solution for infusion

DRUGOmvoh 200 mg solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Transmural response (TR25): decrease of at least (>=) 25% of C-score in each and all active segment from baseline to week 24	—

Secondary

Measure	Time frame
Composite endpoint combining clinical remission and transmural response (TR25) at 6 months, Clinical remission will be defined according to PRO-2, Transmural response will be defined as a decrease of at least 25% of C-score in each active segment at baseline, Improvement or normalization of bowel urgency according to UNRS and Urgent score BU clinical meaningful improvement was defined as decrease of >=3 points, BU Remission was defined as UNRS =<2, Transmural response (TR50): decrease of at least 50% of C-score in each active segment at baseline, Transmural healing: C-score < 0.5 in each active segment at baseline/TRENCH definition, Complete transmural healing: C-score = 0 in each active segment at baseline, MaRIA at 6 months, IUS transmural response/healing at week 4,8, 12 and 24, Bowel damage (Lemann Index) at 6 and 18 months, Clinical response and remission at week 4,8, 12 and 24, Biochemical remission at week 4,8, 12 and 24, Drug retention, IBD-disability index, IBDQ, 10 points-Acc	—

Measure

Time frame

Composite endpoint combining clinical remission and transmural response (TR25) at 6 months, Clinical remission will be defined according to PRO-2, Transmural response will be defined as a decrease of at least 25% of C-score in each active segment at baseline, Improvement or normalization of bowel urgency according to UNRS and Urgent score BU clinical meaningful improvement was defined as decrease of >=3 points, BU Remission was defined as UNRS =<2, Transmural response (TR50): decrease of at least 50% of C-score in each active segment at baseline, Transmural healing: C-score < 0.5 in each active segment at baseline/TRENCH definition, Complete transmural healing: C-score = 0 in each active segment at baseline, MaRIA at 6 months, IUS transmural response/healing at week 4,8, 12 and 24, Bowel damage (Lemann Index) at 6 and 18 months, Clinical response and remission at week 4,8, 12 and 24, Biochemical remission at week 4,8, 12 and 24, Drug retention, IBD-disability index, IBDQ, 10 points-Acc

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Outcome results

None listed