Tofacitinib Registry of Patients With Ulcerative Colitis in Germany
NCT04032756
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Adult Trials: 18+ Years
- Patients with moderate to severe Ulcerative Colitis aged 18-80 years at enrollment
- Written informed consent is given
- Malignant disease in history (except for non-melanoma skin cancer)
- Any contraindication according to the SmPC of the respective medication
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| Descriptive Information | |||||||||
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| Brief Title | Tofacitinib Registry of Patients With Ulcerative Colitis in Germany | ||||||||
| Official 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 | ||||||||
| Brief Summary | 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. | ||||||||
| Detailed Description | This is an Investigator-initiated non-randomized, non-interventional observational prospective long- term research (IIR) as part of the normal treatment of UC patients for the safety and efficacy of Tofacitinib / biologic therapies. As of 01st July 2019, UC patients who have been provided Tofacitinib / biologics for UC according the respective label by the treating physician may be prospectively included in an online database by the participating study centers by 31st March 2021. An interim analysis is planned at the end of patients ? recruitment with respect of the induction phase (week 16) for October 2021 with a first publication of the data in a peer-reviewed journal (e.g., JCC, GUT, UEG Journal). Up to 480 patients (including about 360 UC patients with Tofacitinib and about 120 UC patients with biologics) will be included in the online documentation. A specification to the study centers regarding the group inclusion (patients treated with Tofacitinib (group 1) or a biologics (group 2)) will not be made; this means, each study center can include patients in both groups. The CED Service GmbH assume that approximately 20-30% of Tofacitinib patients will be biologic-nai?ve UC patients, many of whom will represent early disease patients (< 2 years after first diagnosis). | ||||||||
| Study Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | ||||||||
| Target Follow-Up Duration | 2 Years | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Up to 480 patients (aged 18-80 years at enrollment) (including about 360 UC patients with Tofacitinib and about 120 UC patients with biologics) will be included in the online documentation. A specification to the study centers regarding the group inclusion (patients treated with Tofacitinib (group 1) or a biologics (group 2)) will not be made; this means, each study center can include patients in both groups. The CED Service GmbH assume that approximately 20-30% of Tofacitinib patients will be biologic-nai?ve UC patients, many of whom will represent early disease patients (< 2 years after first diagnosis). | ||||||||
| Condition |
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| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||
| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment | 480 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | September 30, 2023 | ||||||||
| Estimated Primary Completion Date | March 31, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts |
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| Listed Location Countries | Germany | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04032756 | ||||||||
| Other Study ID Numbers | Protocol V1.4 31.05.2019 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Ced Service GmbH | ||||||||
| Study Sponsor | Ced Service GmbH | ||||||||
| Collaborators | Pfizer | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | Ced Service GmbH | ||||||||
| Verification Date | February 2020 | ||||||||