Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis Treatment
- Registration Number
- NCT02261636
- Lead Sponsor
- Ferring Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pentasa mesalazine Treatment according to standard clinical practice.
- Primary Outcome Measures
Name Time Method Time to dose reduction From Day 1 up to one year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Gelre Ziekenhuizen (there may be other sites in this country)
🇳🇱Zutphen, Netherlands