E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Ulcerative colitis is a chronic (long-standing) inflammatory condition of the lining of the colon (large bowel). |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10009900 |
E.1.2 | Term | Colitis ulcerative |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine whether vedolizumab is present in significant quantities in the stool of patients receiving induction therapy with vedolizumab for active UC. |
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E.2.2 | Secondary objectives of the trial |
To evaluate whether the presence and quantity of vedolizumab in stool can be used to predict primary non-response to vedolizumab.
To explore whether a correlation exists between stool vedolizumab concentrations, serum vedolizumab concentrations and UC disease activity and extent.
To determine whether there is a correlation between stool and serum vedolizumab levels and trafficking of Th1/Th17 effector memory CD4+ T-cells (the key pathogenic subset in IBD) to the colon in UC.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Aged 18 years or over, either male or female
•Moderate-to-severe UC, defined as:
-SCCAI > 5 and,
i.A raised fecal calprotectin (> 59 μg/g) or,
ii.A raised CRP (> 5 mg/L) or,
iii.Endoscopic disease activity Mayo 2 or above,
Evaluated within 6 weeks of study enrollment
•Commencing vedolizumab treatment
•Sufficient English language skills to understand the patient information sheet and consent form
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E.4 | Principal exclusion criteria |
•Contra-indication to vedolizumab (i.e. known serious or severe hypersensitivity reaction to vedolizumab or any of its excipients)
•Imminent need for colectomy (i.e. colectomy is being planned)
•Previous ileoanal pouch formation
•Active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections
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E.5 End points |
E.5.1 | Primary end point(s) |
Our primary endpoint is the identification and quantification of vedolizumab loss in faecal samples of patients with active UC. Following this, the correlation between faecal and serum vedolizumab concentrations will be evaluated |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline, week 2, week 6 and week 14. |
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E.5.2 | Secondary end point(s) |
Assessment of the impact of faecal vedolizumab concentrations on rates of clinical and endoscopic response to induction therapy with vedolizumab. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline, weeks 2, 6 and 14 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial will be deemed as date of final database lock and completion of analysis of laboratory samples
collected from participants. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 31 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 31 |