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 |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039073 |
E.1.2 | Term | Rheumatoid arthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue 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 evaluate the long-term efficacy of secukinumab with respect to ACR20, ACR50 and ACR70 response over time up to Week 260 in subjects with active rheumatoid arthritis who had previously experienced an inadequate or intolerant response to anti-TNF-alpha therapy and who completed the CAIN457F2302 core study |
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E.2.2 | Secondary objectives of the trial |
1- To evaluate the long-term safety and tolerability of secukinumab over time up to Week 260 in subjects with active rheumatoid arthritis
2- To assess long-term efficacy of secukinumab over time up to Week 260 with respect to:
- The absolute values and change from baseline in DAS28
- The proportion of subjects achieving low disease activity (DAS28 ≤ 3.2 and good/moderate EULAR response)
- The proportion of subjects who achieve disease remission as defined by DAS28 (DAS28 < 2.6) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Subjects must give a written informed consent before any assessment is performed
- Subjects must have completed the 104-week treatment period in the core study
- Subjects who are deemed by the investigator to benefit from continued secukinumab therapy |
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E.4 | Principal exclusion criteria |
- Use of other investigational drugs except for secukinumab during the core study
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
- Women of child-bearing potential, defined as all women physiogically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment
Other protocol-definied exclusion criteria may apply. |
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E.5 End points |
E.5.1 | Primary end point(s) |
ACR20, 50 and 70 (Response by American College of Rheumatology response criteria) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline, and every 3 months |
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E.5.2 | Secondary end point(s) |
- Functional ability and activity restriction measure, HAQ-DI [1]
- Proportion of patients achieving Major Clinical Response [1]
- RA disease activity as measured by Disease Activity Score (DAS28) [1]
- Proportion of subjects achieving Low Disease Activity and good/moderate EULAR responses [1]
- Proportion of subjects achieving ACR/EULAR remission [1]
- Changes in individual ACR components relative to baseline [1]
- Changes in the van der Heijde total modified Sharp score relative to baseline [1]
- Changes in the quality of life outcomes measured by SF-36 v2, relative to baseline [1]
- Safety and tolerability [2]
- Development of immunogenicity against secukinumab [3] |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
[1] Baseline, and every 3 months
[2] Baseline and every visit
[3] Baseline, annually, and at study completion |
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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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | 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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 27 |
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 | No |
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 |
Argentina |
Belgium |
Canada |
Colombia |
Guatemala |
Hungary |
India |
Italy |
Japan |
Mexico |
Panama |
Thailand |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |