Ulcerative Colitis Clinical Trial
— OPTIMUMOfficial title:
Observatoire Prospectif, Longitudinal Dans la Prise en Charge Thérapeutique de La Rectocolite Hémorragique légère à Modérée
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.
| Status | Completed |
| Enrollment | 812 |
| Est. completion date | October 2015 |
| Est. primary completion date | October 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Hospitalier pays d aix | Aix en Provence Cedex 1 | |
| France | Investigational site | Amboise | |
| France | Cabinet Médical | Amiens | |
| France | CMAD | Amiens | |
| France | Clinique Saint Joseph | Angers | |
| France | Investigational site | Anglet | |
| France | Cabinet Médical | Arras | |
| France | Hopital Robert Ballanger | Aulnay Sous Bois Cedex | |
| France | Investigational site | Aulnays Sous Bois | |
| France | Polyclinique Ste Marguerite | Auxerre | |
| France | Investigational site | Beausoleil | |
| France | Clinique ANNE D'ERTOIS | Bethune | |
| France | Le Rabelais | Beziers | |
| France | Centre Hospitalier de Blois | Blois | |
| France | Investigational site | Bordeaux | |
| France | CH de Bourg-en Bresse Hopital de Fleyriart (Viriat) | Bourg En Bresse Cedex | |
| France | Polyclinique Jean Villar | Bruges Cedex | |
| France | Cabinet Médical | Caen | |
| France | Cabinet Medical | Cahors | |
| France | Polyclinic Montréal | Carcassonne | |
| France | Investigational site | Carpentras | |
| France | Maison de Consultations | Cesson Sevigne Cedex | |
| France | Investigational site | Challes Les Eaux | |
| France | CH de Chambery | Chambery | |
| France | Pole Santé Léonard de Vinci | Chambray Les Tours | |
| France | Cabinet Médical | Charleville Mezieres | |
| France | Centre Hospitalier du Haut Anjou Hospital St Julien | Château Gontier | |
| France | Cabinet Médical | Chateaubriant | |
| France | Cabinet Médical | Chateauroux | |
| France | Hospital | Chateauroux | |
| France | Investigational site | Chateauroux | |
| France | CH Chateauroux | Chateauroux Cedex | |
| France | Cabinet Médical | Cherbourg | |
| France | Investigational site | Chinon | |
| France | Cabinet Médical | Clermont Ferrand Cedex 2 | |
| France | Cabinet Médical | Colombes | |
| France | Clinique des Cèdres | Cornebarrieu | |
| France | Centre Hospitalier LAENNEC | Creil Cedex | |
| France | Hospital | Creteil | |
| France | Investigational site | Creteil | |
| France | CHI Créteil | Creteil Cedex | |
| France | Hospital | Creteil Cedex | |
| France | Cabinet Médical | Dax | |
| France | Cabinet Médical | Decines Charpieu | |
| France | Investigational site | Dijon | |
| France | Investigational site | Dole | |
| France | Octogone | Draguignan | |
| France | Hospital De Dreux | Dreux | |
| France | Hopital Simone Veil | Eaubonne | |
| France | Cabinet Médical | Echirolles | |
| France | Clinic De La Présentation | Fleury-les-aubrais | |
| France | Centre Hospitalier du Val d'Ariège | Foix CEDEX | |
| France | Investigational site | Fontenay Le Comte | |
| France | Investigational site | Gien | |
| France | Cabinet Médical | Grenoble | |
| France | Investigational site | Guigamp Pabu | |
| France | Investigational site | Irigny | |
| France | Cabinet Médical | La Chaussee St Victor | |
| France | Sarthe et Loir / Médecine IV Hospital | La Fleche | |
| France | Hospital Les Oudairies | La Roche Sur Yon Cedex | |
| France | Centre Hospitalier Departemental Les Oudairies | La roche Sur Yon Cedex 9 | |
| France | Cabinet Médical | La Varenne St Hilaire | |
| France | CH Lagny Marne La Vallee | Lagny Sur Marne | |
| France | Clinique St Ame | Lambres les Douai | |
| France | Investigational site | Lannion | |
| France | Investigational site | Le Cannet | |
| France | Clinique bon Secours | Le Puy En Velay | |
| France | Cabinet Médical | Lille | |
| France | Investigational site | Limoges | |
| France | Polyclinique de Lisieux | Lisieux | |
| France | Investigational site | Lorient | |
| France | Hopital Prive Jean Mermoz | Lyon Cedex 8 | |
| France | Hopital Privé Jean Mermoz | Lyon Cedex 8 | |
| France | Cabinet Médical | Marseille | |
| France | Hopital Clinique Claude Bernard | Metz | |
| France | HPM Site Sainte-Andre | Metz | |
| France | Private hospital of Metz | Metz | |
| France | CHG Montauban | Montauban Cedex | |
| France | Cabinet Médical | Montelimard | |
| France | Centre Hospitalier Montélimard | Montelimard | |
| France | Investigational site | Montelimard | |
| France | Centre Hospitalier Montelimard | Montelimard CEDEX | |
| France | CHI Le Raincy Montfermeil | Montfermeil | |
| France | Hospital Le Raincy Montfermeil | Montfermeil | |
| France | Cabinet Médical | Montpellier | |
| France | Hospital Saint Eloi | Montpellier | |
| France | Hopital Saint Eloi | Montpellier CEDEX 5 | |
| France | Investigational site | Montrouge | |
| France | Cabinet Médical | Mulhouse | |
| France | Centre Erdre-Saint Augustin | Nantes | |
| France | Centre Medical Erdre-St Augustin | Nantes | |
| France | Centre Médical Erdre-St Augustin | Nantes | |
| France | Investigational site | Narbonne | |
| France | Cabinet Médical | Nice | |
| France | Investigational site | Nice | |
| France | CHU de Nice-Hopital de l'Archet | Nice Cedex 3 | |
| France | Cabinet Médical | Nimes | |
| France | Le Méridien | Nimes | |
| France | Investigational site | Niort | |
| France | Hopital de Guingamp | Pabu | |
| France | Cabinet Médical | Paris | |
| France | Clinique du Louvre | Paris | |
| France | Investigational site | Paris | |
| France | Centre Hospitalier de Perpignan | Perpignan | |
| France | Cabinet Médical | Prades | |
| France | Centre Hospitalier d'Annecy | Pringy Cedex | |
| France | Cabinet Médicale | Quevert | |
| France | Investigational site | Reims | |
| France | Clinique La Sagesse | Rennes | |
| France | Investigational site | Riom | |
| France | Investigational site | Rodez | |
| France | Clinique de l'Europe | Rouen | |
| France | Clinique Mathilde | Rouen | |
| France | Investigational site | Saint Brieuc | |
| France | Investigational site | Saint Jean de Luz | |
| France | Cabinet Lamartine | Saint Nazaire | |
| France | Investigational site | Saint Quentin | |
| France | Centre Médical des Châtaigniers | Saint-herblain | |
| France | Cabinet Médical | Saint-Jean-De-Vedas | |
| France | Cabinet Médical | Sarreguemines | |
| France | Investigational site | Sarreguemines | |
| France | Cabinet Médical | Saumur | |
| France | Cabinet Médical | Savigny sur orge | |
| France | Cabinet Médical | Sevran | |
| France | Centre Hospitalier Prive Saint Gregoire | St Gregoire | |
| France | Centre Hospitalier Privé Saint Gregoire | St Gregoire | |
| France | Investigational site | St Lo | |
| France | Polyclinique de l'Ocean | St Nazaire | |
| France | Polyclinique de l'Océan | St Nazaire | |
| France | Investigational site | St Raphael | |
| France | Cabinet Médical | Strasbourg | |
| France | Cabinet Médical | Sucy en Brie | |
| France | Investigational site | Tarbes | |
| France | Investigational site | Thionville | |
| France | Cabinet Médical | Toulon | |
| France | Clinic Saint Jean Languedoc | Toulouse | |
| France | Investigational site | Toulouse | |
| France | Cabinet Médical | Tourcoing | |
| France | Centre Hospitalier de Tourcoing-Hôpital DRON | Tourcoing | |
| France | Investigational site | Tournefeuille | |
| France | Cabinet Médical | Troyes | |
| France | Clinic | Valence | |
| France | Centre Hospitalier de Valence | Valence Cedex 9 | |
| France | Hospital of Valence | Valence Cedex 9 | |
| France | Centre Hospitalier de Valenciennes | Valenciennes | |
| France | Investigational site | Vannes | |
| France | Cabinet Médical | Vendome | |
| France | Groupe hospitalier les Portes du Sud | Venissieux | |
| France | Groupe Hospitalier Mutualiste "Les Portes du Sud" | Venissieux | |
| France | Groupe Hospitalier Mutualiste Les Portes du Sud | Venissieux | |
| France | Centre Futura Medica | Verguigneul | |
| France | Investigational site | Vernon | |
| France | Cabinet Médical | Vesoul | |
| France | Centre Chirurgical St laurent | Villemoisson sur orge | |
| France | Hospital of Villeneuve Saint Georges | Villeneuve saint georges | |
| France | CH Villeneuve Saint Georges | Villeneuve Saint Georges Cedex | |
| France | CHIV | Villeneuve Saint-Georges | |
| France | Cabinet Médical | Vincennes | |
| France | Investigational site | Vincennes |
| Lead Sponsor | Collaborator |
|---|---|
| Ferring Pharmaceuticals |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score) | From baseline (inclusion visit) and at 1 year interval after baseline | Yes | |
| Primary | Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score) | From baseline (inclusion visit) and at 2 year interval after baseline | Yes | |
| Primary | Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score) | From baseline (inclusion visit) and at 3 year interval after baseline | Yes | |
| Secondary | Remission rate (endoscopic) - calculated by UC-DAI (Ulcerative Colitis Disease Activity Index) | From baseline (inclusion visit) and at 1 year interval after baseline | Yes | |
| Secondary | Assessing treatment adherence by patient's completion of questionnaire MMAS-8 (Modified Morisky Adherence Scale) | From baseline (inclusion visit) and at 1 year interval after baseline | No | |
| Secondary | Occurence/number of adverse events | From baseline (inclusion visit) to year 3 after baseline | Yes | |
| Secondary | Colonoscopy (if available) - assessing endoscopic activity of the ulcerative colitis | From baseline (inclusion visit) to 3 year after baseline | Yes | |
| Secondary | Remission rate (endoscopic) - calculated by UC-DAI (Ulcerative Colitis Disease Activity Index) | From baseline (inclusion visit) and at 2 year interval after baseline | Yes | |
| Secondary | Remission rate (endoscopic) - calculated by UC-DAI (Ulcerative Colitis Disease Activity Index) | From baseline (inclusion visit) and at 3 year interval after baseline | Yes | |
| Secondary | Assessing treatment adherence by patient's completion of questionnaire MMAS-8 (Modified Morisky Adherence Scale) | From baseline (inclusion visit) and at 2 year interval after baseline | No | |
| Secondary | 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 | No |
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