Moderately to Severely Active Crohn's Disease (CD)
Conditions
Brief summary
1. Clinical remission, defined as CDAI < 150,, 2. Endoscopic response, defined as decrease in SES-CD from baseline ≥ 50%,
Detailed description
1. Clinical remission, as defined above,, 2. Endoscopic response, as defined above,, 3. Symptomatic remission,, 4. Endoscopic remission,, 5. Ulcer-free endoscopy,, 6. SF, from baseline, 7. APS, from baseline, 8. Endoscopic remission,, 9. Symptomatic remission,, 10. Corticosteroid-free clinical remission,, 11. Maintenance of clinical remission,, 12. Maintenance of endoscopic response,, 13. Clinical remission and endoscopic remission,, 14. Ulcer-free endoscopy,, 15. Bowel urgency, from baseline, 16. Fatigue, as measured by Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F), from baseline, 17. Inflammatory Bowel Disease Questionnaire (IBDQ) score, from baseline, 18. Clinical remission, 19. Clinical remission, 20. Endoscopic response, 21. Endoscopic response, 22. Clinical response,, 23. Symptomatic response,, 24. Overall change in CD symptoms,, 25. Overall severity in CD symptoms,, 26. General well-being, from baseline, 27. Incidence and severity of the following: - Adverse events, 28. Incidence and severity of the following: - Serious adverse events, 29. Incidence and severity of the following: - Adverse events leading to study treatment discontinuation, 30. Incidence and severity of the following: - Adverse events of special interest, 31. Presence of draining fistulas
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical remission, defined as CDAI < 150,, 2. Endoscopic response, defined as decrease in SES-CD from baseline ≥ 50%, | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical remission, as defined above,, 2. Endoscopic response, as defined above,, 3. Symptomatic remission,, 4. Endoscopic remission,, 5. Ulcer-free endoscopy,, 6. SF, from baseline, 7. APS, from baseline, 8. Endoscopic remission,, 9. Symptomatic remission,, 10. Corticosteroid-free clinical remission,, 11. Maintenance of clinical remission,, 12. Maintenance of endoscopic response,, 13. Clinical remission and endoscopic remission,, 14. Ulcer-free endoscopy,, 15. Bowel urgency, from baseline, 16. Fatigue, as measured by Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F), from baseline, 17. Inflammatory Bowel Disease Questionnaire (IBDQ) score, from baseline, 18. Clinical remission, 19. Clinical remission, 20. Endoscopic response, 21. Endoscopic response, 22. Clinical response,, 23. Symptomatic response,, 24. Overall change in CD symptoms,, 25. Overall severity in CD symptoms,, 26. General well-being, from baseline, 27. Incidence and severity of the following: - A | — |
Countries
Austria, Belgium, Bulgaria, Croatia, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Slovakia, Spain