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

Ferring

Status: Completed

Conditions: Ulcerative Colitis

Treatments: Drug: mesalazine

Study type: Observational

Funder types: Industry

Identifiers

NCT02261636

000157

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

150 participants in 1 patient group

Pentasa

Description:

Treatment according to standard clinical practice.

Treatment:

Drug: mesalazine