E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to Severe Rheumatoid Arthritis |
Artritis reumatoide moderada a grave. |
|
E.1.1.1 | Medical condition in easily understood language |
Rheumatoid Arthritis |
Artritis 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. |
Evaluar la seguridad, la tolerabilidad y la eficacia de ABBV-154 administrado cada 2 semanas (C2S) y cada 4 semanas (C4S) por vía subcutánea (SC) en comparación con placebo en sujetos con AR activa moderada a grave y respuesta insuficiente a al menos un FARMEb/sd previo. |
|
E.2.2 | Secondary objectives of the trial |
To assess the pharmacokinetics (PK), pharmacodynamics, and immunogenicity of ABBV 154. |
Evaluar la farmacocinética (FC), la farmacodinámica y la inmunogenicidad de 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 anti-rheumatic drugs (b/tsDMARDs) treatment for RA. 4. Participants must be on stable dose of methotrexate (MTX). |
1. Diagnóstico clínico de artritis reumatoide (AR) con cumplimiento de los criterios de clasificación ACR/EULAR (European League Against Rheumatism) 2010 para la AR. 2. El sujeto presenta ≥ 6 articulaciones inflamadas (sobre un recuento de 66 articulaciones) y ≥ 6 articulaciones dolorosas (sobre un recuento de 68 articulaciones) en el momento basal. 3. El sujeto debe haber tenido una respuesta insuficiente a al menos un tratamiento previo con fármacos antirreumáticos modificadores de la enfermedad biológicosy/ o sintéticos dirigidos (FARMEb/sd) para la AR. 4. Los sujetos deben estar en una dosis estable de metotrexato (MTX). |
|
E.4 | Principal exclusion criteria |
1. Participant discontinued prior adalimumab therapy due to intolerability or toxicity. |
1. Sujetos que hayan interrumpido el tratamiento previo con adalimumab debido a intolerancia o toxicidad. |
|
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. |
Consecución de una mejoría del 50%, determinada mediante los criterios de respuesta del American College of Rheumatology (ACR50), en la semana 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 |
1. Variación de la puntuación de actividad de la enfermedad (DAS) 28 (PCR) con respecto al momento basal. 2. Variación del índice de actividad clínica de la enfermedad (CDAI) con respecto al momento basal. 3. Consecución de una respuesta ACR20. 4. Consecución de una respuesta ACR70. 5. Consecución de una actividad baja de la enfermedad (ABE) definida por una puntuación DAS28 (PCR) ≤ 3,2. 6. Consecución de una ABE definida por una puntuación CDAI ≤ 10. 7. Consecución de una remisión clínica definida por una puntuación DAS28 (PCR) < 2.6. 8. Consecución de una remisión clínica definida por una puntuación CDAI ≤ 2.8. 9. Variación de la puntuación en el cuestionario de evaluación de la salud - índice de discapacidad (HAQ-DI) con respecto al momento basal. |
|
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 |
|
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 | 8 |
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 | 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 |
Australia |
Canada |
Israel |
Japan |
Korea, Republic of |
New Zealand |
Puerto Rico |
Russian Federation |
Taiwan |
Turkey |
Ukraine |
United States |
Germany |
Greece |
Hungary |
Italy |
Netherlands |
Poland |
Slovakia |
Spain |
United Kingdom |
Czechia |
|
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. |
El fin de estudio viene definido como la fecha de la última visita del último sujeto o fecha del último contacto de seguimiento, la que sea posterior. |
|
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 |