Clinical trial NCT01387698: Prospective, Longitudinal Multicentric Survey in the Therapeutic Care of Mild to Moderate Ulcerative Colitis
Official title: Observatoire Prospectif, Longitudinal Dans la Prise en Charge Thérapeutique de La Rectocolite Hémorragique légère à Modérée
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-07-04
Enrollment: 812
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients at least 18 years old suffering from mild to moderate active ulcerative colitis (whatever the extension)

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.


Eligibility criteria: 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

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