Trial · NCT03375424
Vedolizumab Study With Inflammatory Bowel Disease Patients in Germany
NCT03375424, Unknown, Ced Service GmbH
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vedolizumab Study With Inflammatory Bowel Disease Patients in Germany. Trials, record NCT03375424. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03375424
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vedolizumab Study With Inflammatory Bowel Disease Patients in Germany
- NCT number
- NCT03375424
- Status
- Unknown
- Enrollment
- 2,500 participants, estimated
- Lead sponsor
- Ced Service GmbH
- Conditions
- Inflammatory Bowel Diseases, Treatment
- Interventions
- vedolizumab
- First posted
- 2017-12-18
- Last updated
- 2017-12-18
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | safety index (Chronic steroid-use ≥ 20 mg for ≥ 6 months, New secreting fistula, Op caused by stenosis, Mortality (all), Hospitalization > 14 days, Long-term-illness (with > 30 days off work), Early retirement) | through study completion, an average of 1 year | Success - no; Failure - yes |
| Secondary | Comparison of the disease course in IBD-patients on Vedolizumab/anti-TNF therapy with IBD-patients with an early-stage disease | during the first 14 weeks after individual participation | percent responders/remitters at week 2, 6 and 14, time to response, time to remission etc. |
| Secondary | Development of a multifactorial model to predict a favorable course of disease | through study completion, an average of 1 year | Controlling the systematic analysis (e.g. Chronic steroid-use ≥ 20 mg for ≥ 6 months, new secreting fistula etc.) to forecast the good treatment of the participants (to avoid the primary outcome and to reach the secondary outcome/remission). |
| Secondary | Online documentation of effectiveness in induction and maintenance therapy including the occurrence of serious side effects | through study completion, an average of 1 year | Online documentation of effectiveness in induction and maintenance therapy including the occurrence of serious side effects (e.g. death, tumor, tuberculosis, serious infection or other side effects requiring hospitalization. |
| Secondary | Efficacy (remission and response) of induction therapy (week 14) | through study completion, an average of 1 year | Efficacy (remission and response) of induction therapy (week 14) |
| Secondary | Generation of health economic data in IBD-patients on biologicals | through study completion, an average of 1 year | Generation of health economic data in IBD-patients on biologicals (number of hospitalizations, kind of disabilties, cost of treatment, quality of life e.g. WPAI-CD or EQ-5D) through CRF. |
| Secondary | Generation of follow-up data on IBD-patients with early disease | through study completion, an average of 1 year | Generation of follow-up data on IBD-patients with early disease (initiation of documentation \< 2 years after first diagnosis) through CRF (e.g. actual diagnostic findings or laboratory reports) and IBD-patients on biologics e.g. actual diagnostic findings or laboratory reports) with reference to treatment modalities and psychosocial impairment among patients. |
| Secondary | Formation of a large-scaled patient-collective of IBD-patients with an early course of disease | through study completion, an average of 1 year | Formation of a large-scaled patient-collective of IBD-patients (350 patients) with an early course of disease (disease course \< 2 years) by combining different registries running on the BIOibd platform (6000 patients) of the IBD Competence Net in Germany for the comparison of special subgroups, e.g. IBD-patients on biologics. |
| Secondary | Efficacy (remission and response) of maintenance therapy (month 6 and 12) | through study completion, an average of 1 year | maintenance therapy (month 6 and 12) |
| Secondary | Efficacy (remission and response) of effectiveness in different subpopulations | through study completion, an average of 1 year | effectiveness in different subpopulations, e.g. based on prior biological therapy (remission: HBI ≤ 4 in CD and partial Mayo Score ≤ 1 plus a bleeding subscore of 0 in UC) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03375424
GET https://conductscience.org/api/trials/v1/NCT03375424/registered