Prospective, Longitudinal Multicentric Survey in the Therapeutic Care of Mild to Moderate Ulcerative Colitis
Completed
- Conditions
- Ulcerative Colitis
- Registration Number
- NCT01387698
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief Summary
The primary objective of this study is to confirm the long-term efficacy (remission and maintenance in remission) of current validated treatments. Each patient will be followed during 3 years in this non-interventional trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 812
Inclusion Criteria
- 18 years old or above
- Ulcerative colitis, whatever the extension, in mild to moderate flare-up (including proctitis)
- Having received the information sheet
Exclusion Criteria
- Participating, at the time of inclusion, in another study using an investigational drug or device
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score) From baseline (inclusion visit) and at 3 year interval after baseline
- Secondary Outcome Measures
Name Time Method Colonoscopy (if available) - assessing endoscopic activity of the ulcerative colitis From baseline (inclusion visit) to 3 year after baseline Occurence/number of adverse events From baseline (inclusion visit) to year 3 after baseline Assessing treatment adherence by patient's completion of questionnaire MMAS-8 (Modified Morisky Adherence Scale) From baseline (inclusion visit) and at 3 year interval after baseline Remission rate (endoscopic) - calculated by UC-DAI (Ulcerative Colitis Disease Activity Index) From baseline (inclusion visit) and at 3 year interval after baseline
Trial Locations
- Locations (80)
Centre Hospitalier pays d aix
🇫🇷Aix en Provence Cedex 1, France
Investigational site
🇫🇷Vincennes, France
Cabinet Médical
🇫🇷Vincennes, France
CMAD
🇫🇷Amiens, France
Clinique Saint Joseph
🇫🇷Angers, France
Hopital Robert Ballanger
🇫🇷Aulnay Sous Bois Cedex, France
Polyclinique Ste Marguerite
🇫🇷Auxerre, France
Clinique ANNE D'ERTOIS
🇫🇷Bethune, France
Le Rabelais
🇫🇷Beziers, France
Centre Hospitalier de Blois
🇫🇷Blois, France
Scroll for more (70 remaining)Centre Hospitalier pays d aix🇫🇷Aix en Provence Cedex 1, France