Moderately to Severely Active Crohn's Disease (CD)
Conditions
Brief summary
1. Clinical remission, defined as Crohn's disease activity index (CDAI) < 150, 2. Endoscopic response, defined as decrease in Simple Endoscopic Score for Crohn's disease (SES-CD) from baseline≥ 50%
Detailed description
1. Symptomatic remission,, 2. Endoscopic remission,, 3. Ulcer-free endoscopy,, 4. Average of daily number of liquid or very soft stools in the past week (SF), from baseline, 5. Average of daily abdominal pain scores in the past week (APS) from baseline, 6. Bowel urgency, from baseline, 7. Fatigue, as measured by Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F), from baseline, 8. Inflammatory Bowel Disease Questionnaire (IBDQ) score, from baseline, 9. Among biomarker-defined subgroups of participants: Clinical remission, 10. Among biomarker-defined subgroups of participants: Endoscopic response, 11. Clinical response, defined as a decrease in CDAI from baseline, 12. Symptomatic response,, 13. Overall change in CD symptoms, as measured by PGIC, from baseline, 14. Overall severity in CD symptoms, as measured by Patient Global Impression of Severity (PGIS), from baseline, 15. General well-being, from baseline, 16. Incidence and severity of the following: Adverse events, 17. Incidence and severity of the following: Serious adverse events, 18. Incidence and severity of the following: Adverse events leading to study treatment discontinuation, 19. Incidence and severity of the following: Adverse events of special interest, 20. Presence of draining fistulas
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical remission, defined as Crohn's disease activity index (CDAI) < 150, 2. Endoscopic response, defined as decrease in Simple Endoscopic Score for Crohn's disease (SES-CD) from baseline≥ 50% | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Symptomatic remission,, 2. Endoscopic remission,, 3. Ulcer-free endoscopy,, 4. Average of daily number of liquid or very soft stools in the past week (SF), from baseline, 5. Average of daily abdominal pain scores in the past week (APS) from baseline, 6. Bowel urgency, from baseline, 7. Fatigue, as measured by Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F), from baseline, 8. Inflammatory Bowel Disease Questionnaire (IBDQ) score, from baseline, 9. Among biomarker-defined subgroups of participants: Clinical remission, 10. Among biomarker-defined subgroups of participants: Endoscopic response, 11. Clinical response, defined as a decrease in CDAI from baseline, 12. Symptomatic response,, 13. Overall change in CD symptoms, as measured by PGIC, from baseline, 14. Overall severity in CD symptoms, as measured by Patient Global Impression of Severity (PGIS), from baseline, 15. General well-being, from baseline, 16. Incidence and severity of the following: Adverse eve | — |
Countries
Austria, Belgium, Bulgaria, Croatia, Czechia, France, Germany, Hungary, Italy, Poland, Portugal, Romania, Slovakia, Spain