Prospective, Longitudinal Multicentric Survey in the Therapeutic Care of Mild to Moderate Ulcerative Colitis

An observational study of Ulcerative Colitis, run by Ferring Pharmaceuticals at 158 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ulcerative Colitis
How many people: 812 participants
Where: 158 sitesFrance
Study dates: Jun 2011to Oct 2015
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: All patients at least 18 years old suffering from mild to moderate active ulcerative colitis (whatever the extension)

Who may be able to join

18 years old or above
Ulcerative colitis, whatever the extension, in mild to moderate flare-up (including proctitis)
Having received the information sheet

Who cannot join

Participating, at the time of inclusion, in another study using an investigational drug or device

Trial locations and contacts

158 sites in 1 country.

City, postcode or hospital

158 sites in 1 country

France158 sites

Centre Hospitalier pays d aix
Aix-en-Provence
Investigational site
Amboise
Cabinet Médical
Amiens
CMAD
Amiens
Clinique Saint Joseph
Angers
Investigational site
Anglet
Cabinet Médical
Arras
Hopital Robert Ballanger
Aulnay-sous-Bois
Investigational site
Aulnays Sous Bois
Polyclinique Ste Marguerite
Auxerre
Investigational site
Beausoleil
Clinique ANNE D'ERTOIS
Béthune
Le Rabelais
Béziers
Centre Hospitalier de Blois
Blois
Investigational site
Bordeaux
CH de Bourg-en Bresse Hopital de Fleyriart (Viriat)
Bourg-en-Bresse
Polyclinique Jean Villar
Bruges
Cabinet Médical
Caen
Cabinet Medical
Cahors
Polyclinic Montréal
Carcassonne
Investigational site
Carpentras
Maison de Consultations
Cesson-Sévigné
Investigational site
Challes-les-Eaux
CH de Chambery
Chambéry
Pole Santé Léonard de Vinci
Chambray-lès-Tours
Cabinet Médical
Charleville-Mézières
Centre Hospitalier du Haut Anjou Hospital St Julien
Château-Gontier
Cabinet Médical
Châteaubriant
Cabinet Médical
Châteauroux
CH Chateauroux
Châteauroux
Hospital
Châteauroux
Investigational site
Châteauroux
Cabinet Médical
Cherbourg
Investigational site
Chinon
Cabinet Médical
Clermont-Ferrand
Cabinet Médical
Colombes
Clinique des Cèdres
Cornebarrieu
Centre Hospitalier LAENNEC
Creil
CHI Créteil
Créteil
Hospital
Créteil
Investigational site
Créteil
Cabinet Médical
Dax
Cabinet Médical
Décines-Charpieu
Investigational site
Dijon
Investigational site
Dole
Octogone
Draguignan
Hospital De Dreux
Dreux
Hopital Simone Veil
Eaubonne
Cabinet Médical
Échirolles
Clinic De La Présentation
Fleury-les-Aubrais
Centre Hospitalier du Val d'Ariège
Foix
Investigational site
Fontenay-le-Comte
Investigational site
Gien
Cabinet Médical
Grenoble
Investigational site
Guigamp Pabu
Investigational site
Irigny
Cabinet Médical
La Chaussée-Saint-Victor
Sarthe et Loir / Médecine IV Hospital
La Flèche
Centre Hospitalier Departemental Les Oudairies
La Roche-sur-Yon
Hospital Les Oudairies
La Roche-sur-Yon
Cabinet Médical
La Varenne-Saint-Hilaire
CH Lagny Marne La Vallee
Lagny-sur-Marne
Clinique St Ame
Lambres-lez-Douai
Investigational site
Lannion
Investigational site
Le Cannet
Clinique bon Secours
Le Puy-en-Velay
Cabinet Médical
Lille
Investigational site
Limoges
Polyclinique de Lisieux
Lisieux
Investigational site
Lorient
Hopital Prive Jean Mermoz
Lyon
Hopital Privé Jean Mermoz
Lyon
Cabinet Médical
Marseille
Hopital Clinique Claude Bernard
Metz
HPM Site Sainte-Andre
Metz
Private hospital of Metz
Metz
CHG Montauban
Montauban
Cabinet Médical
Montelimard
Centre Hospitalier Montélimard
Montelimard
Investigational site
Montelimard
Centre Hospitalier Montelimard
Montelimard Cedex
CHI Le Raincy Montfermeil
Montfermeil
Hospital Le Raincy Montfermeil
Montfermeil
Cabinet Médical
Montpellier
Hopital Saint Eloi
Montpellier
Hospital Saint Eloi
Montpellier
Investigational site
Montrouge
Cabinet Médical
Mulhouse
Centre Erdre-Saint Augustin
Nantes
Centre Medical Erdre-St Augustin
Nantes
Centre Médical Erdre-St Augustin
Nantes
Investigational site
Narbonne
Cabinet Médical
Nice
CHU de Nice-Hopital de l'Archet
Nice
Investigational site
Nice
Cabinet Médical
Nîmes
Le Méridien
Nîmes
Investigational site
Niort
Hopital de Guingamp
Pabu
Cabinet Médical
Paris
Clinique du Louvre
Paris
Investigational site
Paris
Centre Hospitalier de Perpignan
Perpignan
Cabinet Médical
Prades
Centre Hospitalier d'Annecy
Pringy
Cabinet Médicale
Quévert
Investigational site
Reims
Clinique La Sagesse
Rennes
Investigational site
Riom
Investigational site
Rodez
Clinique de l'Europe
Rouen
Clinique Mathilde
Rouen
Investigational site
Saint-Brieuc
Centre Hospitalier Prive Saint Gregoire
Saint-Grégoire
Centre Hospitalier Privé Saint Gregoire
Saint-Grégoire
Centre Médical des Châtaigniers
Saint-Herblain
Investigational site
Saint-Jean-de-Luz
Cabinet Médical
Saint-Jean-de-Védas
Investigational site
Saint-Lô
Cabinet Lamartine
Saint-Nazaire
Polyclinique de l'Ocean
Saint-Nazaire
Polyclinique de l'Océan
Saint-Nazaire
Investigational site
Saint-Quentin
Investigational site
Saint-Raphaël
Cabinet Médical
Sarreguemines
Investigational site
Sarreguemines
Cabinet Médical
Saumur
Cabinet Médical
Savigny-sur-Orge
Cabinet Médical
Sevran
Cabinet Médical
Strasbourg
Cabinet Médical
Sucy-en-Brie
Investigational site
Tarbes
Investigational site
Thionville
Cabinet Médical
Toulon
Clinic Saint Jean Languedoc
Toulouse
Investigational site
Toulouse
Cabinet Médical
Tourcoing
Centre Hospitalier de Tourcoing-Hôpital DRON
Tourcoing
Investigational site
Tournefeuille
Cabinet Médical
Troyes
Centre Hospitalier de Valence
Valence
Clinic
Valence
Hospital of Valence
Valence
Centre Hospitalier de Valenciennes
Valenciennes
Investigational site
Vannes
Cabinet Médical
Vendôme
Groupe hospitalier les Portes du Sud
Vénissieux
Groupe Hospitalier Mutualiste "Les Portes du Sud"
Vénissieux
Groupe Hospitalier Mutualiste Les Portes du Sud
Vénissieux
Centre Futura Medica
Verguigneul
Investigational site
Vernon
Cabinet Médical
Vesoul
Centre Chirurgical St laurent
Villemoisson-sur-Orge
CH Villeneuve Saint Georges
Villeneuve-Saint-Georges
CHIV
Villeneuve-Saint-Georges
Hospital of Villeneuve Saint Georges
Villeneuve-Saint-Georges
Cabinet Médical
Vincennes
Investigational site
Vincennes

Other trials in France

About this study

Official title: Observatoire Prospectif, Longitudinal Dans la Prise en Charge Thérapeutique de La Rectocolite Hémorragique légère à Modérée

Conditions: Ulcerative Colitis
Medical subject headings: Colitis, Ulcerative

What is being measured

The primary outcome is the main question the study is designed to answer.

Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score)
Measured: From baseline (inclusion visit) and at 1 year interval after baseline
Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score)
Measured: From baseline (inclusion visit) and at 2 year interval after baseline
Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score)
Measured: 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)
Measured: 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)
Measured: From baseline (inclusion visit) and at 1 year interval after baseline
Occurence/number of adverse events
Measured: From baseline (inclusion visit) to year 3 after baseline
Colonoscopy (if available) - assessing endoscopic activity of the ulcerative colitis
Measured: From baseline (inclusion visit) to 3 year after baseline
Remission rate (endoscopic) - calculated by UC-DAI (Ulcerative Colitis Disease Activity Index)
Measured: From baseline (inclusion visit) and at 2 year interval after baseline
Remission rate (endoscopic) - calculated by UC-DAI (Ulcerative Colitis Disease Activity Index)
Measured: 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)
Measured: 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)
Measured: From baseline (inclusion visit) and at 3 year interval after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011Oct 2015

First posted4 Jul 2011 (estimated)
Study startJun 2011
Primary completionOct 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 812 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01387698
Sponsor's protocol ID: FE999907 CS09
Acronym: OPTIMUM
Status last verified: Oct 2015
First submitted: 29 Jun 2011
Last updated: 29 Oct 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
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RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease

All Ulcerative Colitis trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observatoire Prospectif, Longitudinal Dans la Prise en Charge Thérapeutique de La Rectocolite Hémorragique légère à Modérée
ClinicalTrials.gov ID: NCT01387698
Acronym / sponsor ID: OPTIMUM / FE999907 CS09
Conditions: Ulcerative Colitis
Study type: Observational
Recruitment status: Completed
Enrolment: 812 participants (actual)
Lead sponsor: Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 4 Jul 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All patients at least 18 years old suffering from mild to moderate active ulcerative colitis (whatever the extension)

Key inclusion criteria (3 listed)

18 years old or above
Ulcerative colitis, whatever the extension, in mild to moderate flare-up (including proctitis)
Having received the information sheet

Key exclusion criteria (1 listed)

Participating, at the time of inclusion, in another study using an investigational drug or device

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

8 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.

Related trials for Ulcerative Colitis

Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Development Support study director

Ferring Pharmaceuticals

158 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis, run by Ferring Pharmaceuticals at 158 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 158 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score) (time frame: From baseline (inclusion visit) and at 1 year interval after baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01387698.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2015.