E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
active steroid-dependent ulcerative colitis |
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E.1.1.1 | Medical condition in easily understood language |
Chronic inflammation of the colon with symptoms and intestinal lesions that need continuous therapy with steroids. |
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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 | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045365 |
E.1.2 | Term | Ulcerative colitis |
E.1.2 | System Organ Class | 100000004856 |
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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 |
Efficacy evaluation of golimumab in inducing clinical and endoscopic remission at week 16 steroid-free |
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E.2.2 | Secondary objectives of the trial |
1 Efficacy of golimumab in inducing and maintaining clinical response at week 16; 2 Efficacy of golimumab in maintaining clinical remission at week 52; 3 Efficacy of golimumab in maintaining the clinical and endoscopic remission at week 52; 4 Efficacy of golimumab in inducing and maintaining mucosal healing at week 16 and week 52; 5 Efficacy of golimumab in inducing healing histological week 16 and week 52; 6 Impact of golimumab on the patients quality of life; 7 Efficacy of the switch, from golinumab to infliximab, for non-responders subjects at week 16; 8 To identify predictors of response to golimumab (including biomarkers of inflammation, sex, age, medical history, baseline and histological healing at week 16).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
a. Patients aged between 18 and 65 at the moment of the inclusion b. Ability to understand the procedures of the study and sign the informed consent form c. Confirmed diagnosis of ulcerative colitis for at least 6 months. d. Naïve to therapy with monoclonal antibodies (both conventional and experimental) and. e. Mayo Score global ≥ 6 at baseline f. Steroid-dependence
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E.4 | Principal exclusion criteria |
a) Diagnosis of Crohn's disease or indeterminate colitis (IBD-U). b) Active infection at baseline or a previous infection that has not healed at baseline. c) History of solid tumors or blood cancers within 5 years of the inclusion. d) Suspected latent tuberculosis infection. e) Any other condition deemed risky for the patient during the study. f) Pregnancy or lactation at baseline, or planned pregnancy screening up to 3 months after the end of the study. g) Concomitant medications at baseline that should be continued during the study and are included in the list of treatments not allowed
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |