E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderately to Severely Active Rheumatoid Arthritis (RA) |
Arttritis Reumatoide (AR) active de moderada a grave |
|
E.1.1.1 | Medical condition in easily understood language |
Rheumatoid Arthritis (RA) |
Artritis Reumatodie (AR) |
|
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 | 18.1 |
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 compare the safety and efficacy of ABT-494 monotherapy versus methotrexate (MTX) monotherapy for the treatment of signs and symptoms of rheumatoid arthritis (RA) in MTX-naïve subjects. ? To compare the efficacy of ABT-494 monotherapy versus MTX monotherapy for prevention of structural progression in MTX-naive subjects with moderately to severely active RA. |
Compara la seguridad y eficacia de ABT-494 en monoterapia frente a Metotrexato (MTX) en monoterapia para el tratamiento de los signos y síntomas de la artritis reumatoide (AR) en pacientes no tratados con MTX. Compara la eficacia de ABT-494 en monoterapia frente a MTX en monoterapia para prevenir la progresión estructural en pacientes no tratados con MTX con AR activa de moderada a grave |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
? Adult male or female, at least 18 years old. ? Diagnosis of RA for ? 3 months. ? Naïve to MTX or, if already on MTX, have received no more than 3 weekly MTX doses with requirement to complete a 4-week MTX washout before the first dose of study drug. ? Subjects with prior exposure to conventional synthetic disease modifying anti-rheumatic drugs other than MTX may be enrolled if completed the washout period. ? Meets the following minimum disease activity criteria: ? 6 swollen joints (based on 66 joint counts) and ? 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits. ? ? 1 bone erosion on x-ray (by local reading) OR in the absence of documented bone erosion, both positive rheumatoid factor and positive anti-cyclic citrullinated peptide autoantibodies are required at Screening. |
Adultos, hombres o mujeres , con al menos 18 años. Diagnóstico de AR de ? 3 meses. No tratado con MTX o, de haberlo recibido, no podrá haber recibido más de 3 dosis de MTX semanales, y deberá pasar por un periodo de lavado de MTX de 4 semanas antes de la primera dosis del fármaco del estudio. Podrán participar los sujetos tratados previamente con antirreumáticos modificadores de la enfermedad sintéticos convencionales distintos de MTX, si pasan por el periodo de lavado Cumplir los siguientes requisitos mínimos de actividad de la enfermedad: ? 6 articulaciones inflamadas (de un total de 66) y ? 6 articulaciones dolorosas (de un total de 68) en las visitas de selección y basal. .? 1 erosiones óseas en la radiografía (evaluador local) O, en ausencia de erosión ósea documentada, deberá dar positivo en la selección para el factor reumatoide y para los autoanticuerpos antipéptido cíclico citrulinado. |
|
E.4 | Principal exclusion criteria |
? Intolerant to MTX. ? Prior exposure to any JAK inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib). ? Prior exposure to any bDMARD(s). ? History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted. |
Intolerante a MTX Exposición previa a cualquier inhibidor de JAK (como tofacitinib, baricitinib y filgotinib, entre otros). Antecedentes de artropatía inflamatoria distinta de la AR. Se permiten los antecedentes de síndrome de Sjogren secundario. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
ACR50 response; Low Disease Activity (LDA) |
Respuesta ACR50: Actividad baja de la enfermedad (LDA) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
? Change from baseline in modified Total Sharp Score (mTSS); ? Change from baseline in Disease Activity Score (DAS) 28 (CRP); ? ACR70 response; ? Change from baseline in HAQ-DI; ? ACR20 response; ? Change from baseline in Short Form-36 (SF-36) Physical Component Score (PCS) ? Clinical Remission (CR) |
Variación en la puntuación de Sharp total modificada ( mTSS) con respecto al momento basal Variación en la graduación de actividad de la enfermedad ( DAS) 28 (PCR) con respecto al momento basal Respuesta ACR70 Variación en HAQ-DI con respecto al momento basal. Respuesta ACR20 Variación del componente físico (PCS) del formulario abreviado 36 (SF-36) con respecto al momento basal Remisión clínica (RC) |
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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 | 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 | 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) | 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 | 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) | Yes |
E.8.2.2 | Placebo | No |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 117 |
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 |
Australia |
Belarus |
Bosnia and Herzegovina |
Brazil |
Canada |
Chile |
China |
Colombia |
Egypt |
European Union |
Hong Kong |
Israel |
Japan |
Kazakhstan |
Korea, Republic of |
Malaysia |
Mexico |
New Zealand |
Puerto Rico |
Russian Federation |
Serbia |
Singapore |
South Africa |
Switzerland |
Taiwan |
Turkey |
Ukraine |
United Kingdom |
United States |
|
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
|
LVLS or last follow up contact whichever is later |
UVUP o el último contacto de seguimiento , lo que sea más tarde |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 19 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 19 |