E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to Severe Rheumatoid Arthritis |
Artrite Reumatoide di Grado da Moderato a Grave |
|
E.1.1.1 | Medical condition in easily understood language |
Rheumatoid Arthritis |
Artrite Reumatoide |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
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 |
|
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 assess the safety, tolerability, and efficacy of ABBV-154 administered every other week (eow) and every 4 weeks (e4w) subcutaneously (SC) vs placebo in subjects with moderately to severely active RA with inadequate response to at least one prior b/tsDMARD. |
Valutare la sicurezza, tollerabilità ed efficacia di ABBV-154 somministrato a settimane alterne (eow) e ogni 4 settimane (e4w) per via sottocutanea (SC) rispetto a placebo in soggetti con AR attiva di grado da moderato a grave con risposta inadeguata ad almeno un b/tsDMARD pregresso. |
|
E.2.2 | Secondary objectives of the trial |
To assess the pharmacokinetics (PK), pharmacodynamics, and immunogenicity of ABBV 154. |
Valutare la farmacocinetica (PK), farmacodinamica e immunogenicità di ABBV-154. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Clinical diagnosis of rheumatoid arthritis(RA) with fulfillment of the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria for RA. 2. Participant has = 6 swollen joints (based on 66 joint count) and = 6 tender joints (based on 68 joint count) at baseline. 3. Participant must have had an inadequate response to at least one prior biologic and/or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) treatment for RA. 4. Participants must be on stable dose of methotrexate (MTX). |
1. Diagnosi clinica di artrite reumatoide (AR) con soddisfacimento dei criteri di classificazione 2010 ACR/EULAR (European League Against Rheumatism) per AR. 2. Partecipante con = 6 articolazioni tumefatte (sulla base di una conta di 66 articolazioni) e = 6 articolazioni dolorabili alla palpazione (sulla base di una conta di 68 articolazioni) al baseline. 3. Il partecipante deve aver avuto una risposta inadeguata ad almeno un trattamento pregresso per AR con farmaco antireumatico modificante la malattia biologico e/o sintetico targeted (b/tsDMARDs) 4. I partecipanti devono essere in trattamento a dose stabile con metotressato (MTX) |
|
E.4 | Principal exclusion criteria |
1. Participant discontinued prior adalimumab therapy due to intolerability or toxicity |
1- Il partecipante ha interrotto la terapia pregressa con adalimumab per motivi di intolleranza o tossicità |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Achievement of 50% improvement as measured by American College of Rheumatology response criteria (ACR50) at Week 12. |
Ottenimento di miglioramento del 50% dei criteri di risposta American College of Rheumatology (ACR50) alla Settimana 12. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1. Change in Disease Activity Score (DAS) 28 (CRP) from Baseline; 2. Change in Clinical Disease Activity Index (CDAI) from Baseline; 3. Achievement of ACR20; 4. Achievement of ACR70; 5. Achievement of Low Disease Activity (LDA) defined by DAS28 (CRP) = 3.2; 6. Achievement of LDA defined by CDAI = 10; 7. Achievement of clinical remission defined by DAS28 (CRP) < 2.6; 8. Achievement of clinical remission defined by CDAI = 2.8; and 9. Change in Health Assessment Questionnaire Disability Index (HAQ-DI) from Baseline |
• Variazione rispetto al Baseline del punteggio DAS (Disease Activity Score) 28 (PCR); • Variazione rispetto al Baseline del punteggio CDAI (Clinical Disease Activity Index); • Ottenimento della risposta ACR20; • Ottenimento della risposta ACR70; • Ottenimento della bassa attività di malattia (Low Disease Activity, LDA) definita sulla base del punteggio DAS28 (PCR) = 3,2; • Ottenimento di LDA definita sulla base del punteggio CDAI = 10; • Ottenimento della remissione clinica definita sulla base del punteggio DAS28 (PCR) < 2,6; • Ottenimento della remissione clinica definita sulla base del punteggio CDAI = 2,8; e • Variazione rispetto al Baseline del punteggio HAQ DI (Health Assessment Questionnaire Disability Index) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
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 |
Also assess Immunogenicity of ABBV-154 |
Valutare anche l'immunogenicità di ABBV-154 |
|
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 | 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 | 5 |
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 | 50 |
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 |
Australia |
Canada |
Israel |
Japan |
Korea, Republic of |
New Zealand |
Puerto Rico |
Russian Federation |
Taiwan |
Turkey |
Ukraine |
United States |
Germany |
Hungary |
Italy |
Netherlands |
Poland |
Slovakia |
Spain |
United Kingdom |
Czechia |
Greece |
|
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
|
The end-of-study is defined as the date of the last subject's last visit or date of the last follow-up contact, whichever is later. |
Per fine dello studio si intende la data dell’ultima visita dell’ultimo soggetto oppure la data dell’ultimo contatto di follow-up, quale dei due avvenga per ultimo |
|
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 | 11 |
E.8.9.1 | In the Member State concerned days | 15 |
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 | 11 |
E.8.9.2 | In all countries concerned by the trial days | 15 |