Colitis, Ulcerative Clinical Trial
— TOFA-UCOfficial title:
Tofacitinib Registry of Patients With Ulcerative Colitis in Germany - Documentation of Tofacitinib Induction and Maintenance Therapy in Conjunction With Long-term Outcome and Predictors of Response
Verified date | September 2021 |
Source | Ced Service GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
This registry on Tofacitinib and biologics (anti-integrin/anti-TNF) in the treatment of ulcerative colitis (UC) patients in Germany will extend the prospective documentation of safety issues and efficacy in induction and maintenance therapy of Tofacitinib (Xeljanz®) in addition to other biologics used in Germany with a particular interest in predictors of long-term responses and favorable disease outcome or to predict severe side effects caused by therapy with Januskinase(JAK)- inhibitors/biologics.
Status | Terminated |
Enrollment | 50 |
Est. completion date | November 15, 2020 |
Est. primary completion date | November 15, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Patients with moderate to severe Ulcerative Colitis aged 18-80 years at enrollment - Written informed consent is given Exclusion Criteria: - Malignant disease in history (except for non-melanoma skin cancer) - Any contraindication according to the SmPC of the respective medication |
Country | Name | City | State |
---|---|---|---|
Germany | Gastroenterologische Gemeinschaftspraxis Minden | Minden | Niedersachsen |
Lead Sponsor | Collaborator |
---|---|
Ced Service GmbH | Pfizer |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | partial Mayo score = 1 plus a bleeding subscore of 0) in the inductionphase (week 16) | The primary endpoint is steroid-free remission (remission: partial Mayo score = 1 plus a bleeding subscore of 0) in the inductionphase (week 16). For this endpoint it will be only captured if there is a current use of steroids at the time of the visit. So the patient will be asked for current steroid use at time of visit at week 16 and if he has received steroids within the last 4 weeks prior to time point of the visit. | 07/01/2019 - 03/31/2023 | |
Secondary | occurrence of serious side effects (e.g., death, tumor, tuberculosis, severe infections, or side effects leading to hospitalization) | Online documentation of safety and efficacy in induction and maintenance therapy including the occurrence of serious side effects (e.g., death, tumor, tuberculosis, severe infections, or side effects leading to hospitalization) | 07/01/2019 - 03/31/2023 | |
Secondary | response: partial Mayo Score reduction of = 3 accompanied by a decrease of at least 30% from baseline and remission: partial Mayo score = 1 plus a bleeding subscore of 0 - Efficacy | Efficacy (response: partial Mayo Score reduction of = 3 accompanied by a decrease of at least 30% from baseline and remission: partial Mayo score = 1 plus a bleeding subscore of 0) of induction therapy (week 8 and 16) and maintenance therapy (months 6 to 24) and efficacy (response and remission) in different subpopulations, e.g. based on a previous biologic therapy or not. | 07/01/2019 - 03/31/2023 | |
Secondary | hospitalization days via question in questionnaire | Obtaining health economic data in UC patients on Tofacitinib / biologics therapy (hospitalization) | 07/01/2019 - 03/31/2023 | |
Secondary | psychosocial impairments - EQ-5D | Obtaining data of the course from UC patients with a new therapy (Tofacitinib / biologics) related to treatment strategy and psychosocial impairments | 07/01/2019 - 03/31/2023 | |
Secondary | EQ-5D quality of life | Obtaining health economic data in UC patients on Tofacitinib / biologics therapy (quality of life) | 07/01/2019 - 03/31/2023 | |
Secondary | early retirement via question in questionnaire | Obtaining health economic data in UC patients on Tofacitinib / biologics therapy (early retirement) | 07/01/2019 - 03/31/2023 |
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