Visit | 1 | 2 | 3 |
---|---|---|---|
Time | Day 1* | End of induction treatment (daily)* | ≥2 weeks after end of last treatment dose |
Informed consent† | x | ||
Inclusion/exclusion criteria | x | ||
Demographics | x | ||
Concomitant diseases | x | ||
UC history | x | ||
Current flare activity | x | x | |
Concomitant treatments | x | x | x |
Effectiveness assessments (UCDAI clinical subscore) | x | x | |
WPAI questionnaire‡ | x | x | |
SIBDQ questionnaire‡ | x | x | |
Treatment satisfaction scale | x | ||
Tolerability | x | x | |
Patient weekly diary§ | x | x | |
Fecal calprotectin¶ | x | x | |
UCDAI endoscopy subscore¶ | x | x |
*Visits will be made in accordance with routine clinical practice, and budesonide MMX treatment must be prescribed in the usual manner in accordance with the terms of the marketing authorisation of each participating country.
†Written informed consent must be obtained prior to any study-related data collection.
‡Depending on country regulations for non-interventional study and on local clinical practice.
§The investigator will also offer the patient a weekly diary. If she/he wishes to complete this, the diary will be provided at inclusion, and the patient will be requested to return the diary to the physician at the end of daily treatment visit, whenever this occurs. The diary will be completed with information related to the last 3 days of the week.
¶Optional: to be collected, if available, because it is considered by the clinician as routine clinical practice.
SIBDQ, Short Inflammatory Bowel Disease Quality of Life; UC, ulcerative colitis; UCDAI, UC Disease Activity Index; WPAI, Work Productivity and Activity Impairment.