E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045265 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received salvage therapy.
Subjects will be grouped for exploratory analysis in this study based mainly on covariates of interest, such as the study drug they received and their outcomes in the previous studies. In particular, the following groups will be considered: 1) early visilizumab failures, ie, subjects who did not respond to treatment with visilizumab within 90 days after receipt of study drug, 2) early placebo failures, ie, subjects who did not have a response within 90 days after receipt of placebo, and 3) late treatment failures, ie, subjects who had disease relapse 90 or more days after receipt of visilizumab or placebo.
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E.2.2 | Secondary objectives of the trial |
To assess the health-related quality of life and pharmacoeconomic outcomes of colectomy and other salvage therapies, and the response to salvage medications in subjects who received salvage therapy. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:
1) Previous participation in an IVSR-UC visilizumab study.
2) Disease progression while enrolled in a previous visilizumab study, and subsequent treatment with salvage therapy. |
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E.4 | Principal exclusion criteria |
1) Unable to understand the purpose and risks of the study, or unwilling or unable to provide signed and dated informed consent.
2) For U.S. sites, unwilling or unable to provide authorization to use protected health information. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the incidence of medically important events, including infections (opportunistic infections and those requiring hospitalization or parenteral therapies), malignancies, lymphoproliferative disorders, pericolectomy complications (up to 60 days after colectomy), and other surgeries, after an initiation of salvage therapy. |
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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 | Yes |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Health-Related Quality of Life |
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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 | Yes |
E.7.1.3.1 | Other trial type description |
Phase II, Obervational follow-up |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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.8.3 |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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Generally 3 years from the time of enrollment in this protocol.
However, if a subject recieves a collectomy the follow-up period is 1 year from the time of surgery. This is regardless of when colectomy occurs within the 3 year follow up.
Subjects may be enrolled concurrently in their prior study in order to complete, per the previous protocol. A 90 day safety follow up and a 1-year follow up for medically significant infections, malignancies, lymphoproliferative disorders and surgery. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |