An observational study in Ulcerative Colitis, sponsored by Ferring Pharmaceuticals. Completed at 159 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-29.
Sponsored by Ferring Pharmaceuticals · Observational
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.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 812 is above the median of 105 across 247 observational studies indexed under Colitis.
Browse Colitis studies →Ferring Pharmaceuticals is the lead sponsor of 244 studies on the registry; 4 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 13 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients at least 18 years old suffering from mild to moderate active ulcerative colitis (whatever the extension)
Exclusion Criteria:
Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score)
Time frame: From baseline (inclusion visit) and at 1 year interval after baseline
Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score)
Time frame: From baseline (inclusion visit) and at 2 year interval after baseline
Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score)
Time frame: From baseline (inclusion visit) and at 3 year interval after baseline
Remission rate (endoscopic) - calculated by UC-DAI (Ulcerative Colitis Disease Activity Index)
Time frame: From baseline (inclusion visit) and at 1 year interval after baseline
Assessing treatment adherence by patient's completion of questionnaire MMAS-8 (Modified Morisky Adherence Scale)
Time frame: From baseline (inclusion visit) and at 1 year interval after baseline
Occurence/number of adverse events
Time frame: From baseline (inclusion visit) to year 3 after baseline
Colonoscopy (if available) - assessing endoscopic activity of the ulcerative colitis
Time frame: From baseline (inclusion visit) to 3 year after baseline
Remission rate (endoscopic) - calculated by UC-DAI (Ulcerative Colitis Disease Activity Index)
Time frame: From baseline (inclusion visit) and at 2 year interval after baseline
Remission rate (endoscopic) - calculated by UC-DAI (Ulcerative Colitis Disease Activity Index)
Time frame: From baseline (inclusion visit) and at 3 year interval after baseline
Assessing treatment adherence by patient's completion of questionnaire MMAS-8 (Modified Morisky Adherence Scale)
Time frame: From baseline (inclusion visit) and at 2 year interval after baseline
Assessing treatment adherence by patient's completion of questionnaire MMAS-8 (Modified Morisky Adherence Scale)
Time frame: From baseline (inclusion visit) and at 3 year interval after baseline
Showing the first 100 of 159 sites.
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Ferring Pharmaceuticals