MedPath

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
NameTimeMethod
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
NameTimeMethod
Colonoscopy (if available) - assessing endoscopic activity of the ulcerative colitisFrom baseline (inclusion visit) to 3 year after baseline
Occurence/number of adverse eventsFrom 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)

Cabinet Médicale

🇫🇷

Quevert, France

Centre Hospitalier pays d aix

🇫🇷

Aix en Provence Cedex 1, France

Clinique Saint Joseph

🇫🇷

Angers, France

Investigational site

🇫🇷

Vincennes, France

Cabinet Médical

🇫🇷

Vincennes, France

CMAD

🇫🇷

Amiens, France

Le Rabelais

🇫🇷

Beziers, France

Hopital Robert Ballanger

🇫🇷

Aulnay Sous Bois Cedex, France

Polyclinique Ste Marguerite

🇫🇷

Auxerre, France

Clinique ANNE D'ERTOIS

🇫🇷

Bethune, France

Cabinet Medical

🇫🇷

Cahors, France

Polyclinique Jean Villar

🇫🇷

Bruges Cedex, France

Centre Hospitalier de Blois

🇫🇷

Blois, France

CH de Bourg-en Bresse Hopital de Fleyriart (Viriat)

🇫🇷

Bourg En Bresse Cedex, France

Polyclinic Montréal

🇫🇷

Carcassonne, France

CH de Chambery

🇫🇷

Chambery, France

Maison de Consultations

🇫🇷

Cesson Sevigne Cedex, France

Pole Santé Léonard de Vinci

🇫🇷

Chambray Les Tours, France

Clinique des Cèdres

🇫🇷

Cornebarrieu, France

CH Chateauroux

🇫🇷

Chateauroux Cedex, France

Hospital

🇫🇷

Creteil, France

Centre Hospitalier du Haut Anjou Hospital St Julien

🇫🇷

Château Gontier, France

CHI Créteil

🇫🇷

Creteil Cedex, France

Centre Hospitalier LAENNEC

🇫🇷

Creil Cedex, France

Hospital De Dreux

🇫🇷

Dreux, France

Octogone

🇫🇷

Draguignan, France

Hopital Simone Veil

🇫🇷

Eaubonne, France

Centre Hospitalier du Val d'Ariège

🇫🇷

Foix CEDEX, France

Clinic De La Présentation

🇫🇷

Fleury-les-aubrais, France

Sarthe et Loir / Médecine IV Hospital

🇫🇷

La Fleche, France

Centre Hospitalier Departemental Les Oudairies

🇫🇷

La roche Sur Yon Cedex 9, France

Hospital Les Oudairies

🇫🇷

La Roche Sur Yon Cedex, France

CH Lagny Marne La Vallee

🇫🇷

Lagny Sur Marne, France

Clinique St Ame

🇫🇷

Lambres les Douai, France

Clinique bon Secours

🇫🇷

Le Puy En Velay, France

Polyclinique de Lisieux

🇫🇷

Lisieux, France

Hopital Privé Jean Mermoz

🇫🇷

Lyon Cedex 8, France

Hopital Prive Jean Mermoz

🇫🇷

Lyon Cedex 8, France

HPM Site Sainte-Andre

🇫🇷

Metz, France

Private hospital of Metz

🇫🇷

Metz, France

Hopital Clinique Claude Bernard

🇫🇷

Metz, France

CHG Montauban

🇫🇷

Montauban Cedex, France

Centre Hospitalier Montelimard

🇫🇷

Montelimard CEDEX, France

CHI Le Raincy Montfermeil

🇫🇷

Montfermeil, France

Hospital Le Raincy Montfermeil

🇫🇷

Montfermeil, France

Hopital Saint Eloi

🇫🇷

Montpellier CEDEX 5, France

Centre Erdre-Saint Augustin

🇫🇷

Nantes, France

Hospital Saint Eloi

🇫🇷

Montpellier, France

Centre Medical Erdre-St Augustin

🇫🇷

Nantes, France

CHU de Nice-Hopital de l'Archet

🇫🇷

Nice Cedex 3, France

Centre Médical Erdre-St Augustin

🇫🇷

Nantes, France

Le Méridien

🇫🇷

Nimes, France

Hopital de Guingamp

🇫🇷

Pabu, France

Clinique du Louvre

🇫🇷

Paris, France

Centre Hospitalier de Perpignan

🇫🇷

Perpignan, France

Centre Hospitalier d'Annecy

🇫🇷

Pringy Cedex, France

Clinique La Sagesse

🇫🇷

Rennes, France

Clinique de l'Europe

🇫🇷

Rouen, France

Clinique Mathilde

🇫🇷

Rouen, France

Cabinet Lamartine

🇫🇷

Saint Nazaire, France

Centre Médical des Châtaigniers

🇫🇷

Saint-herblain, France

Centre Hospitalier Prive Saint Gregoire

🇫🇷

St Gregoire, France

Centre Hospitalier Privé Saint Gregoire

🇫🇷

St Gregoire, France

Polyclinique de l'Ocean

🇫🇷

St Nazaire, France

Polyclinique de l'Océan

🇫🇷

St Nazaire, France

Clinic Saint Jean Languedoc

🇫🇷

Toulouse, France

Centre Hospitalier de Tourcoing-Hôpital DRON

🇫🇷

Tourcoing, France

Centre Hospitalier de Valence

🇫🇷

Valence Cedex 9, France

Hospital of Valence

🇫🇷

Valence Cedex 9, France

Clinic

🇫🇷

Valence, France

Centre Hospitalier de Valenciennes

🇫🇷

Valenciennes, France

Groupe hospitalier les Portes du Sud

🇫🇷

Venissieux, France

Groupe Hospitalier Mutualiste "Les Portes du Sud"

🇫🇷

Venissieux, France

CH Villeneuve Saint Georges

🇫🇷

Villeneuve Saint Georges Cedex, France

Hospital of Villeneuve Saint Georges

🇫🇷

Villeneuve saint georges, France

CHIV

🇫🇷

Villeneuve Saint-Georges, France

Centre Futura Medica

🇫🇷

Verguigneul, France

Centre Hospitalier Montélimard

🇫🇷

Montelimard, France

Groupe Hospitalier Mutualiste Les Portes du Sud

🇫🇷

Venissieux, France

Centre Chirurgical St laurent

🇫🇷

Villemoisson sur orge, France

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