Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis Treatment
IMPACT
1 other identifier
observational
150
1 country
1
Brief Summary
For both induction of remission and in maintenance of remission, different doses and treatment durations are used in practice. The aim of this study is to assess how mesalazine is used in clinical practice, at which doses and for how long and how these differences impact the patient disease state and work productivity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2014
CompletedFirst Posted
Study publicly available on registry
October 10, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2019
CompletedMay 20, 2022
February 1, 2019
4 years
October 7, 2014
May 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Time to dose reduction
From Day 1 up to one year
Study Arms (1)
Pentasa
Treatment according to standard clinical practice.
Interventions
Eligibility Criteria
Out-patient clinics in the Netherlands
You may qualify if:
- Patients with mild to moderate active ulcerative colitis with disease extension beyond the rectum (≥ 10 cm) who will receive oral Pentasa treatment (Compact sachets and/or tablets) for the treatment of the current active episode or in whom on oral Pentasa maintenance treatment induction of remission treatment will be initiated by dose escalation. Treatment combined with Pentasa enema (1g/100ml) is allowed.
- Informed consent
You may not qualify if:
- Patients receiving treatment with one or more of the following: locally acting steroids (e.g. budesonide, beclomethasone), systemic steroids, immunosuppressants (e.g. thiopurines), biologicals (e.g. anti-Tumor Necrosis Factor-alpha)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gelre Ziekenhuizen (there may be other sites in this country)
Zutphen, Netherlands
Related Publications (1)
West R, Russel M, Bodelier A, Kuijvenhoven J, Bruin K, Jansen J, Van der Meulen A, Keulen E, Wolters L, Ouwendijk R, Bezemer G, Koussoulas V, Tang T, Van Dobbenburgh A, Van Nistelrooy M, Minderhoud I, Vandebosch S, Lubbinge H. Lower Risk of Recurrence with a Higher Induction Dose of Mesalazine and Longer Duration of Treatment in Ulcerative Colitis: Results from the Dutch, Non-Interventional, IMPACT Study. J Gastrointestin Liver Dis. 2022 Mar 19;31(1):18-24. doi: 10.15403/jgld-3927.
PMID: 35306553RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Compliance
Ferring Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2014
First Posted
October 10, 2014
Study Start
January 1, 2015
Primary Completion
January 14, 2019
Study Completion
January 14, 2019
Last Updated
May 20, 2022
Record last verified: 2019-02