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OpenTrials
Completed

NCT Number: NCT01387698

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

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier pays d aix, Aix-en-Provence, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score)

    Time frame: From baseline (inclusion visit) and at 1 year interval after baseline

  2. Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score)

    Time frame: From baseline (inclusion visit) and at 2 year interval after baseline

  3. Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score)

    Time frame: From baseline (inclusion visit) and at 3 year interval after baseline

Secondary outcomes

  1. 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

  2. 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

  3. Occurence/number of adverse events

    Time frame: From baseline (inclusion visit) to year 3 after baseline

  4. Colonoscopy (if available) - assessing endoscopic activity of the ulcerative colitis

    Time frame: From baseline (inclusion visit) to 3 year after baseline

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: OPTIMUM

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jul 4, 2011
Registry last updated
Oct 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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