Prospective, Longitudinal Multicentric Survey in the Therapeutic Care of Mild to Moderate Ulcerative Colitis
OPTIMUM
Observatoire Prospectif, Longitudinal Dans la Prise en Charge Thérapeutique de La Rectocolite Hémorragique légère à Modérée
1 other identifier
observational
812
1 country
158
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2011
Longer than P75 for all trials
158 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 29, 2011
CompletedFirst Posted
Study publicly available on registry
July 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedOctober 29, 2015
October 1, 2015
4.3 years
June 29, 2011
October 28, 2015
Conditions
Outcome Measures
Primary Outcomes (3)
Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score)
From baseline (inclusion visit) and at 1 year interval after baseline
Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score)
From baseline (inclusion visit) and at 2 year interval after baseline
Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score)
From baseline (inclusion visit) and at 3 year interval after baseline
Secondary Outcomes (8)
Remission rate (endoscopic) - calculated by UC-DAI (Ulcerative Colitis Disease Activity Index)
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)
From baseline (inclusion visit) and at 1 year interval after baseline
Occurence/number of adverse events
From baseline (inclusion visit) to year 3 after baseline
Colonoscopy (if available) - assessing endoscopic activity of the ulcerative colitis
From baseline (inclusion visit) to 3 year after baseline
Remission rate (endoscopic) - calculated by UC-DAI (Ulcerative Colitis Disease Activity Index)
From baseline (inclusion visit) and at 2 year interval after baseline
- +3 more secondary outcomes
Eligibility Criteria
All patients at least 18 years old suffering from mild to moderate active ulcerative colitis (whatever the extension)
You may qualify if:
- years old or above
- Ulcerative colitis, whatever the extension, in mild to moderate flare-up (including proctitis)
- Having received the information sheet
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (158)
Centre Hospitalier pays d aix
Aix-en-Provence, 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, France
Investigational site
Aulnays Sous Bois, France
Polyclinique Ste Marguerite
Auxerre, France
Investigational site
Beausoleil, France
Clinique ANNE D'ERTOIS
Béthune, France
Le Rabelais
Béziers, France
Centre Hospitalier de Blois
Blois, France
Investigational site
Bordeaux, France
CH de Bourg-en Bresse Hopital de Fleyriart (Viriat)
Bourg-en-Bresse, France
Polyclinique Jean Villar
Bruges, France
Cabinet Médical
Caen, France
Cabinet Medical
Cahors, France
Polyclinic Montréal
Carcassonne, France
Investigational site
Carpentras, France
Maison de Consultations
Cesson-Sévigné, France
Investigational site
Challes-les-Eaux, France
CH de Chambery
Chambéry, France
Pole Santé Léonard de Vinci
Chambray-lès-Tours, France
Cabinet Médical
Charleville-Mézières, France
Centre Hospitalier du Haut Anjou Hospital St Julien
Château-Gontier, France
Cabinet Médical
Châteaubriant, France
Cabinet Médical
Châteauroux, France
CH Chateauroux
Châteauroux, France
Hospital
Châteauroux, France
Investigational site
Châteauroux, France
Cabinet Médical
Cherbourg, France
Investigational site
Chinon, France
Cabinet Médical
Clermont-Ferrand, France
Cabinet Médical
Colombes, France
Clinique des Cèdres
Cornebarrieu, France
Centre Hospitalier LAENNEC
Creil, France
CHI Créteil
Créteil, France
Hospital
Créteil, France
Investigational site
Créteil, France
Cabinet Médical
Dax, France
Cabinet Médical
Décines-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
Échirolles, France
Clinic De La Présentation
Fleury-les-Aubrais, France
Centre Hospitalier du Val d'Ariège
Foix, 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 Chaussée-Saint-Victor, France
Sarthe et Loir / Médecine IV Hospital
La Flèche, France
Centre Hospitalier Departemental Les Oudairies
La Roche-sur-Yon, France
Hospital Les Oudairies
La Roche-sur-Yon, France
Cabinet Médical
La Varenne-Saint-Hilaire, France
CH Lagny Marne La Vallee
Lagny-sur-Marne, France
Clinique St Ame
Lambres-lez-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, France
Hopital Privé Jean Mermoz
Lyon, 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, France
Centre Hospitalier Montelimard
Montelimard Cedex, France
Cabinet Médical
Montelimard, France
Centre Hospitalier Montélimard
Montelimard, France
Investigational site
Montelimard, France
CHI Le Raincy Montfermeil
Montfermeil, France
Hospital Le Raincy Montfermeil
Montfermeil, France
Cabinet Médical
Montpellier, France
Hopital Saint Eloi
Montpellier, France
Hospital Saint Eloi
Montpellier, 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
CHU de Nice-Hopital de l'Archet
Nice, France
Investigational site
Nice, France
Investigational site
Niort, France
Cabinet Médical
Nîmes, France
Le Méridien
Nîmes, 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, France
Cabinet Médicale
Quévert, 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
Centre Hospitalier Prive Saint Gregoire
Saint-Grégoire, France
Centre Hospitalier Privé Saint Gregoire
Saint-Grégoire, France
Centre Médical des Châtaigniers
Saint-Herblain, France
Investigational site
Saint-Jean-de-Luz, France
Cabinet Médical
Saint-Jean-de-Védas, France
Investigational site
Saint-Lô, France
Cabinet Lamartine
Saint-Nazaire, France
Polyclinique de l'Ocean
Saint-Nazaire, France
Polyclinique de l'Océan
Saint-Nazaire, France
Investigational site
Saint-Quentin, France
Investigational site
Saint-Raphaël, France
Cabinet Médical
Sarreguemines, France
Investigational site
Sarreguemines, France
Cabinet Médical
Saumur, France
Cabinet Médical
Savigny-sur-Orge, France
Cabinet Médical
Sevran, 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
Centre Hospitalier de Valence
Valence, France
Clinic
Valence, France
Hospital of Valence
Valence, France
Centre Hospitalier de Valenciennes
Valenciennes, France
Investigational site
Vannes, France
Cabinet Médical
Vendôme, France
Centre Futura Medica
Verguigneul, France
Investigational site
Vernon, France
Cabinet Médical
Vesoul, France
Groupe hospitalier les Portes du Sud
Vénissieux, France
Groupe Hospitalier Mutualiste "Les Portes du Sud"
Vénissieux, France
Groupe Hospitalier Mutualiste Les Portes du Sud
Vénissieux, France
Centre Chirurgical St laurent
Villemoisson-sur-Orge, France
CH Villeneuve Saint Georges
Villeneuve-Saint-Georges, France
CHIV
Villeneuve-Saint-Georges, France
Hospital of Villeneuve Saint Georges
Villeneuve-Saint-Georges, France
Cabinet Médical
Vincennes, France
Investigational site
Vincennes, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2011
First Posted
July 4, 2011
Study Start
June 1, 2011
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
October 29, 2015
Record last verified: 2015-10