Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis Treatment (IMPACT)

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: mesalazine

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Netherlands
  • Zutphen, Netherlands
    • Gelre Ziekenhuizen (there may be other sites in this country)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Out-patient clinics in the Netherlands

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pentasa; Treatment according to standard clinical practice.	Drug: mesalazine; Other Names: Pentasa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to dose reduction	From Day 1 up to one year

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ACTUAL): January 14, 2019
• Study Completion (ACTUAL): January 14, 2019

Study Registration Dates

• First Submitted: October 7, 2014
• First Submitted That Met QC Criteria: October 9, 2014
• First Posted (ESTIMATE): October 10, 2014

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Mesalamine
• Other Study ID Numbers: 000157