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 | 14.1 |
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 demonstrate the superior efficacy of secukinumab administered during induction with an i.v. loading regimen or a s.c. loading dose regimen compared to placebo in patients with active rheumatoid arthritis despite treatment with methotrexate using the ACR 20 criteria. |
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E.2.2 | Secondary objectives of the trial |
To compare the secukinumab regimens (i.v. and s.c.) to placebo and to each other for ACR 20, ACR 50 and ACR 70 response criteria, Health Assessment Questionnaire-Disability Index, Disease Activity Score (DAS) 28 response, ACR components, including markers of inflammation and to evaluate the overall safety and tolerability of secukinumab and investigate the development of immunogenicity against secukinumab. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Presence of Rheumatoid Arthritis classified by ACR 2010 revised criteria for at least 3 months before screening
- Must have been taking Methotrexate for at least 3 months before randomization and must currently be on a stable dose of Methotrexate for at least 4 weeks before randomization
- At baseline : disease activity criteria defined by ≥ 6 tender joints out of 68 and ≥ 6 swollen joints out of 66 and with at least 1 of the following at screening: anti-CCP antibodies positive or rheumatoid factor positive and with at least 1 of the following at screening: hsCRP ≥ 10 mg/L or ESR ≥ 28 mm/1st hr
Other protocol-defined inclusion criteria may apply. |
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E.4 | Principal exclusion criteria |
- Rheumatoid arthritis patients functional status class IV according to the ACR 1991 revised criteria
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor
- Previous exposure ever to an anti-TNF-α agent or any other immunomodulatory biologic agent (experimental or approved)
- Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine)
- Any therapy by intra-articular injections (e.g. corticosteroid, hyaluronan) required for treatment of arthritis within 4 weeks before randomization.
Other protocol-defined exclusion criteria may apply. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Response to treatment according to ACR 20 criteria |
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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) |
- ACR 20, ACR 50, and ACR 70 response criteria
- Change from baseline in HAQ-DI values
- DAS28-CRP, DAS28-ESR, and EULAR response criteria
- ACR component variables |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
For all secondary endpoints: every visit, Week 0 to 52
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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 | 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 | Yes |
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) | 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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 35 |
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 |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
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 | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |