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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01387698
First received: June 29, 2011
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition
Ulcerative Colitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observatoire Prospectif, Longitudinal Dans la Prise en Charge Thérapeutique de La Rectocolite Hémorragique légère à Modérée

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score) [ Time Frame: From baseline (inclusion visit) and at 1 year interval after baseline ] [ Designated as safety issue: Yes ]
  • Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score) [ Time Frame: From baseline (inclusion visit) and at 2 year interval after baseline ] [ Designated as safety issue: Yes ]
  • Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score) [ Time Frame: From baseline (inclusion visit) and at 3 year interval after baseline ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Occurence/number of adverse events [ Time Frame: From baseline (inclusion visit) to year 3 after baseline ] [ Designated as safety issue: Yes ]
  • Colonoscopy (if available) - assessing endoscopic activity of the ulcerative colitis [ Time Frame: From baseline (inclusion visit) to 3 year after baseline ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: June 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01387698

  Show 159 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01387698     History of Changes
Other Study ID Numbers: FE999907 CS09
Study First Received: June 29, 2011
Last Updated: April 10, 2014
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: French Data Protection Authority
France: Conseil National de l'Ordre des Médecins

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014