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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: November 18, 2014
Last verified: November 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: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: November 18, 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
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014