E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Rheumatoid Arthritis (RA) |
Artritis Reumatoide (AR) |
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E.1.1.1 | Medical condition in easily understood language |
Rheumatoid Arthritis (AR) |
Artritis Reumatoide (RA) |
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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 | 17.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10021428 |
E.1.2 | Term | Immune system disorders |
E.1.2 | System Organ Class | 10021428 - Immune system 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 assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered s.c. to subjects with active RA |
Evaluar la eficacia y seguridad de distintas pautas de dosificación de ALX-0061, administrado por vía subcutánea (s.c.) como monoterapia a sujetos con AR activa |
|
E.2.2 | Secondary objectives of the trial |
To assess the effects of ALX-0061 on quality of life, PK, PD, and immunogenicity of ALX 0061 and to explore potential dose regimens for ALX 0061 monotherapy, based on safety and efficacy, for further clinical development.
To obtain parallel descriptive information concerning the efficacy and safety of tocilizumab (TCZ) s.c. in the same clinical trial RA population. |
? Evaluar los efectos de ALX-0061 sobre la calidad de vida, la farmacocinética (FC) y la farmacodinámica (FD), así como la inmunogenicidad de ALX-0061, y explorar posibles pautas de dosificación de ALX-0061 en monoterapia basadas en la seguridad y la eficacia para el desarrollo clínico posterior. ? Obtener, paralelamente, información descriptiva sobre la eficacia y seguridad de tocilizumab (TCZ) s.c. en la población con AR de este mismo ensayo clínico. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Man or woman ? 18 years and < 75 years of age at the time of signing the informed consent form. - Diagnosis of RA for at least 6 months prior to screening, and ACR functional class I-III. - Received previous or current treatment with MTX, and is considered intolerant to MTX, or for whom continued treatment with MTX is considered inappropriate, or have contraindications for MTX use. - Subjects must not have received MTX for at least 4 weeks before first administration of the study drug. - Active RA
A complete list of selection criteria can be found in the body of the Clinical Study Protocol |
- Varones o mujeres ? 18 años y < 75 años de edad en el momento de firmar el documento de consentimiento informado. - Diagnóstico de AR como mínimo 6 meses antes de la selección y una clase funcional del ACR de I-III. - Haber recibido tratamiento previo o actual con MTX, y que se consideren intolerantes a dicho fármaco, o sujetos para los que se considere inadecuado el tratamiento continuado con MTX o que presenten contraindicaciones para la terapia con MTX. - Los sujetos no deberán haber recibido MTX durante como mínimo las 4 semanas previas a la primera administración del fármaco del estudio. - AR activa
Una lista completa de los criterios de selección se puede encontrar en el protocolo |
|
E.4 | Principal exclusion criteria |
- Have been treated with DMARDs/systemic immunosuppressive prior to first administration of study drug. - Have received approved or investigational biological or targeted synthetic DMARD therapies for RA less than 6 months prior to screening. - Have a history of toxicity, non-tolerance, primary non-response or inadequate response to a biological therapy, or targeted synthetic DMARDs (including JAK inhibitors), for RA. - Have received prior therapy blocking the interleukin-6 (IL-6) pathway at any time.
A complete list of selection criteria can be found in the body of the Clinical Study Protocol. |
- Haber sido tratado con FARME/inmunosupresores sistémicos previo a la primera administración del fármacodel estudio, - Haber recibido terapias con FARME sintéticos dirigidos o agentes biológicos, autorizados o en investigación, para la AR con una anterioridad inferior a 6 meses respecto a la selección. - Antecedentes de toxicidad, intolerancia, ausencia de respuesta primaria o respuesta inadecuada a una terapia biológica o a FARME sintéticos dirigidos para el tratamiento de la AR. ? Haber recibido previamente terapias bloqueantes de la vía de la interleucina-6 (IL-6) en cualquier momento.
Una lista completa de los criterios de selección se puede encontrar en el protocolo |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of subjects achieving an ACR20 response at Week 12. |
la proporción de sujetos que consiga una respuesta ACR20 en la Semana 12. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
-ACR20, ACR50, and ACR70 response over time. -Disease activity: Disease Activity Score using 28 joint counts (DAS28 using CRP and erythrocyte sedimentation rate [ESR]), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI). -EULAR DAS28 response (good, moderate, or no response). -Remission using disease remission parameters: DAS28, SDAI, CDAI, Boolean. -Health Assessment Questionnaire-Disability Index (HAQ-DI). -Physical and mental component scores of Short Form Health Survey (SF-36). -Functional Assessment of Chronic Illness Therapy-Fatigue (FACITFatigue). -Pharmacokinetics -Pharmacodynamics -Safety -Immunogenicity |
- Respuesta ACR20, ACR50 y ACR70 a lo largo del tiempo. - Actividad de la enfermedad: Puntuación de Actividad de la Enfermedad basada en el recuento de 28 articulaciones (DAS28, utilizando el valor de PCR y la velocidad de sedimentación globular [VSG]), el índice de actividad de la enfermedad simplificado (IAES) y el índice clínico de la actividad de la enfermedad (ICAE). - Respuesta del DAS28 según el EULAR (buena, moderada o sin respuesta). - Remisión, utilizando los parámetros de remisión de la enfermedad: DAS28, IAES, ICAE y definición basada en el análisis Booleano. - Cuestionario de evaluación de la salud - Índice de discapacidad (Health Assessment Questionnaire-Disability Index, HAQ-DI). - Puntuaciones de los componentes físico y mental de la Short Form Health Survey (SF-36). - Evaluación funcional del tratamiento en la enfermedad crónica ? Fatiga (Functional Assessment of Chronic Illness Therapy-Fatigue, FACIT-Fatiga). - Farmacocinética: - Farmacodinámica - Seguridad - Inmunogenicidad |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Time points for all secondary endpoints above are 12 weeks except Pharmacodynamics, Safety and Immunogenicity, the time point for which is 24 weeks |
Evaluaciones para las variables secundaria esta por encima de las 12 semanas excepto para la Farmacocinética, Farmacodinámica, Seguridad e Inmunogenicidad que son 24 semanas |
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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 | Yes |
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) | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 27 |
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 |
Belgium |
Bulgaria |
Czech Republic |
Georgia |
Germany |
Hungary |
Macedonia, the former Yugoslav Republic of |
Mexico |
Moldova, Republic of |
Poland |
Romania |
Serbia |
Spain |
United States |
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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
|
Last visit of the last subject |
|
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 | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |