E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Radiographic Axial Spondyloarthritis |
Spondiloartrite Assiale Radiografica |
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E.1.1.1 | Medical condition in easily understood language |
A chronic inflammatory condition affecting the spine and sacroiliac joint. It is characterized by pain and stiffness of joints. |
Una condizione infiammatoria cronica che colpisce la colonna vertebrale e l'articolazione sacro-iliaca. Essa è caratterizzata da dolore e rigidità delle articolazioni. |
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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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10041672 |
E.1.2 | Term | Spondylitis ankylosing |
E.1.2 | System Organ Class | 100000004859 |
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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 |
Compare both ixekizumab regimens (80 mg every 2 weeks or 80 mg every 4 weeks) vs placebo in tumor necrosis factor inhibitor (TNFi) experienced patients with active radiographic axial spondyloarthritis (r-axSpA) at Week 16. |
Confrontare entrambi i regimi terapeutici di Ixekizumab (80 mg ogni 2 settimane o 80 mg ogni 4 settimane) con il placebo in pazienti affetti da Spondiloartrite Assiale Radiografica (r-axSPA) trattati con anti-TNFa alla Settimana 16. |
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E.2.2 | Secondary objectives of the trial |
To compare both ixekizumab regimens (80 mg every 2 weeks or 80 mg every 4 weeks) to placebo at Week 16 on signs and symptoms, function, mobility, and quality of life in TNFi experienced patients with r-axSpA. |
Confrontare entrambi i regimi terapeutici di Ixekizumab (80 mg ogni 2 settimane o 80 mg ogni 4 settimane) con il placebo alla Settimana 16 riguardo i segni e sintomi, la funzione, la capacità motoria, e la qualità della vita in pazienti affetti da Spondiloartrite Assiale Radiografica (r-axSPA) trattati con anti-TNFa. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Other types of substudies Specify title, date and version of each substudy with relative objectives: There is a MRI substudy that will be conducted in selected countries. Patients will have MRIs of the spine at screening and at Week 16. The MRI addendum version is 23Nov2015.
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Altre tipologie di sottostudi specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Vi è un sotto-studio per la Risonanza Magnetica che sarà condotto in Paesi selezionati. I pazienti effettueranno una Risonanza Magnetica della colonna vertebrale al momento dello screening e alla Settimana 16. La versione dell’addendum per la Risonanza Magnetica è 23-Novembre-2015.
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E.3 | Principal inclusion criteria |
-Are at least 18 years of age -Have an established diagnosis of radiographic axial spondyloarthritis (r-axSpA) with sacroiliitis defined radiographically according to the mNY criteria -Patients have a history of back pain =3 months with age at onset <45 years. -Have had prior treatment with at least 1 and not more than 2 TNF inhibitors. -Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs. -Have given written informed consent |
- Pazienti maggiorenni, almeno 18 anni; - Pazienti con una diagnosi confermata di Spondiloartrite Assiale Radiografica (r-axSpA) con sacroileite definita radiograficamente secondo i criteri di New York modificati (mNY); - Pazienti con una storia di dolore alla schiena =3 mesi con l’età di esordio ‹ 45 anni; - Trattamento precedente con almeno 1 e non più di 2 anti-TNFa; - Pazienti con un’inadeguata risposta a 2 o più Farmaci Antinfiammatori Non Steroidei (FANS) all’intervallo di dosaggio terapeutico per una durata totale di almeno 4 settimane OPPURE con una storia di intolleranza ai Farmaci Antinfiammatori Non Steroidei (FANS); - Pazienti che hanno firmato il modulo di Consenso Informato. |
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E.4 | Principal exclusion criteria |
- Have total ankylosis of the spine -Have taken none or more than two tumor necrosis factor inhibitor medications - Have recently received a live vaccine within 12 weeks or have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year. - Have an ongoing or serious infection within the last 12 weeks or evidence of active tuberculosis - Have a compromised immune system. - Have any other serious and/or uncontrolled diseases. - Have either a current diagnosis or a recent history of malignant disease. - Have had Major surgery within 8 weeks of baseline, or will require surgery during the study - Are pregnant or breastfeeding
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- Pazienti con totale anchilosi della colonna vertebrale; - Non abbiano assunto nessun farmaco anti-TNFa oppure ne abbiano assunti più di due; - Abbiano ricevuto di recente un vaccino vivo entro le 12 settimane o abbiano effettuato una vaccinazione contro il bacillo di Calmette e Guérin nell’anno precedente; - Abbiano un’infezione in atto o con caratteristiche di serietà entro le 12 settimane precedenti o evidenza di tubercolosi attiva; - Abbiano un sistema immunitario compromesso; - Abbiano qualsiasi altra malattia grave e incontrollata; - Abbiano o una diagnosi attuale o una storia recente di malignità; - Abbiano subito interventi di chirurgia maggiore entro le 8 settimane dal baseline, o necessitino di subire interventi durante lo studio; - Siano in stato di gravidanza o in allattamento |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) response. |
Percentuale di pazienti che hanno raggiunto una risposta ASAS40 (Assessment of Spondiloarthritis International Society 40). |
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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) |
1) Proportion of patients achieving an ASAS20 response
2) Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
3) Proportion of patients achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) response
4) Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
5) Proportion of patients achieving ASDAS inactive disease
6) Change from baseline in Short Form 36 (SF-36) physical component score (PCS) 7) Change from baseline in ASAS Health Index (ASAS HI)
8) Change from baseline in magnetic resonance imaging (MRI) of the spine (Ankylosing Spondylitis Spinal Magnetic Resonance Imaging [ASSpiMRI] Berlin score). (This endpoint applies to MRI addendum only). |
1) Percentuale di pazienti che hanno raggiunto una risposta ASAS20;
2) Variazione rispetto al basale del punteggio ASDAS (Ankylosing Spondylitis Disease Activity Score);
3) Percentuale di pazienti che hanno raggiunto una risposta BASDAI50 (Bath Ankylosing Spondylitis Functional Index);
4) Variazione rispetto al basale dell’indice BASFI (Bath Ankylosing Spondylitis Functional Index);
5) Percentuale di pazienti che hanno ottenuto la valutazione ASDAS di malattia inattiva;
6) Variazione rispetto al basale del punteggio relativo alla componente fisica (PCS) del questionario SF-36 (Short Form 36);
7) Variazioni rispetto al basale dell’indice ASAS sulla salute (ASAS HI);
8) Variazione rispetto al basale della Risonanza Magnetica (RM) della colonna vertebrale (ASSpiMRI [Ankylosing Spondylitis Spinal Magnetic Resonance Imaging] – criteri di Berlino) (Questo endpoint si applica solo all’addendum RM).
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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 | 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 | 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) | Yes |
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 | 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 | 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
| 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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 44 |
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 |
Argentina |
Brazil |
Canada |
Finland |
France |
Germany |
Hungary |
Israel |
Italy |
Korea, Republic of |
Mexico |
Netherlands |
Poland |
Puerto Rico |
Spain |
United Kingdom |
United States |
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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 | 2 |
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 | 2 |
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 |