E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects with Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment |
Pacientes con polimialgia reumática (PMR) dependientes del tratamiento con glucocorticoides |
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E.1.1.1 | Medical condition in easily understood language |
Polymyalgia Rheumatica |
Polimialgia reumática |
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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 | 21.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036099 |
E.1.2 | Term | Polymyalgia rheumatica |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue 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 safety and efficacy of ABBV-154 versus placebo in subjects with PMR, who are dependent on treatment with glucocorticoids with doses of at least 5 mg/day prednisone equivalent (glucocorticoid-dependent PMR). |
Evaluar la seguridad y eficacia de ABBV-154 Vs Placebo en pacientes con PMR, que son dependientes del tratamiento con glucocorticoides con dosis de al menos 5mg/día de prednisona equivalente (PMR dependiente-glucocorticoide) |
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E.2.2 | Secondary objectives of the trial |
To assess the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ABBV-154. |
Evaluar la farmacocinética (FC), la farmacodinámica (FD) y la inmunogenicidad de ABBV-154. |
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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 |
Wearable Device Substudy- For collection of subject's upper limbs range of motion, daily activity, and sleep parameters. |
Subestudio de dispositivo portátil: para recopilar el rango de movimiento de las extremidades superiores, la actividad diaria y los parámetros del sueño del sujeto. |
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E.3 | Principal inclusion criteria |
1. Adults 50 – 80 years of age with a clinical diagnosis of PMR and fulfillment of the 2012 EULAR/ACR provisional classification criteria for PMR. 2. Following a confirmed diagnosis of PMR, subject must have shown a clinical response to prednisone (or equivalent dose) of 5 to 25 mg/day. 3. Subject must have had at least 2 episodes of unequivocal PMR flare while attempting to taper prednisone, with the dose of prednisone (or equivalent) at the time of flare ≥ 5 mg/day, prior to Baseline; the most recent flare must have been within 24 weeks of Baseline. Unequivocal PMR flare is defined as clinical signs and symptoms of PMR (shoulder and/or hip girdle pain with inflammatory stiffness, neck pain with inflammatory stiffness, or new or worsened limited range of motion of hips and/or shoulders) that resulted in an increase in glucocorticoid dose. 4. Subject must be on a stable prednisone (or equivalent) dose of 5 to 15 mg/day for ≥ 2 weeks prior to Baseline. Subjects may be on up to 25 mg/day at the Screening Visit provided that the subject is able to taper to 15 mg/day or less, with a stable dose ≥ 2 weeks prior to Baseline. 5. Subject must be willing to follow the protocol-defined glucocorticoid tapering regimen. |
1. Adultos de 50-80 años con un diagnóstico clínico de PMR y que cumplan los criterios de clasificación provisionales de la PMR de la EULAR/ACR de 2012. 2. Tras un diagnóstico confirmado de PMR, el sujeto debe haber mostrado una respuesta clínica a prednisona (o dosis equivalente) de 5 a 25 mg/día. 3. El sujeto debe haber tenido al menos 2 episodios de brote inequívoco de PMR mientras intentaba reducir gradualmente la prednisona, con una dosis de prednisona (o equivalente) en el momento del brote ≥ 5 mg/día, antes del momento basal; el brote más reciente debe haber tenido lugar en las 24 semanas previas al momento basal. Un brote inequívoco de PMR se define como la presencia de signos y síntomas clínicos de PMR (dolor en la cintura escapular y/o pélvica con rigidez inflamatoria, dolor cervical con rigidez inflamatoria o aparición o empeoramiento de una limitación de la amplitud del movimiento de las caderas y/o los hombros) que provocó un aumento de la dosis de glucocorticoides. 4. El sujeto deberá haber recibido una dosis estable de prednisona (o equivalente) de 5 a 15 mg/día durante ≥2 semanas antes de la visita basal. Los sujetos podrán recibir hasta 25 mg/día en la visita de selección siempre que puedan reducir gradualmente la dosis hasta 15 mg/día o menos, con una dosis estable ≥2 semanas antes de la visita basal. 5. El sujeto debe estar dispuesto a seguir la pauta de reducción gradual de glucocorticoides definida en el protocolo. |
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E.4 | Principal exclusion criteria |
1. Subject must have discontinued use of immunomodulators other than prednisone (or equivalent) prior to Baseline 2. Subjects requiring > 25 mg/day of prednisone to control confirmed PMR are excluded 3. Subject must not exhibit clinical signs and symptoms of PMR (shoulder and/or hip girdle pain with inflammatory stiffness, neck pain with inflammatory stiffness, or new or worsened limited range of motion of hips and/or shoulders) within 2 weeks of Baseline |
1. El sujeto debe haber discontinuado el uso de inmunomoduladores distintos de la prednisona (o equivalente) antes de la visita basal 2. Los pacientes que requieran > 25 mg/día prednisona para controlar PMR confirmada son excluidos. 3. El sujeto no debe presentar signos y síntomas clínicos de PMR (dolor en el hombro y / o cintura de la cadera con rigidez inflamatoria, dolor de cuello con rigidez inflamatoria o rango de movimiento limitado nuevo o empeorado de caderas y / o hombros) dentro de las 2 semanas posteriores al inicio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to flare, where flare is defined as follows: • Presence of clinical signs and symptoms of PMR AND • Requirement to increase the glucocorticoid dose per investigator.
Clinical signs and symptoms of PMR are defined as shoulder and/or hip girdle pain with inflammatory stiffness, neck pain with inflammatory stiffness, or new or worsened limited range of motion of hips and/or shoulders that are not due to other causes |
Tiempo hasta el brote, definiéndose el brote como sigue: •Presencia de signos y síntomas clínicos de PMR Y •Necesidad de aumentar la dosis de glucocorticoides según el investigador. Los signos y síntomas clínicos de PMR se definen como dolor en la cintura escapular y/o pélvica con rigidez inflamatoria, dolor cervical con rigidez inflamatoria o aparición o empeoramiento de una limitación de la amplitud del movimiento de las caderas y/o los hombros que no se debe a otras causas. |
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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) |
• Achievement of flare-free state up to Week 24 • Cumulative glucocorticoid dose by 24 weeks • Change from Baseline in glucocorticoid dose at Week 24 |
• Consecución del estado sin brotes hasta la semana 24 • Dosis acumulada de glucocorticoides a las 24 semanas • Variación de la dosis de glucocorticoides respecto al estado basal en la semana 24 |
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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 | 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 | Yes |
E.6.11 | Pharmacogenomic | Yes |
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 |
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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 | 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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 38 |
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 |
Japan |
Korea, Republic of |
New Zealand |
United States |
Austria |
France |
Germany |
Hungary |
Italy |
Netherlands |
Poland |
Spain |
United Kingdom |
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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
|
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. |
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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 | |
E.8.9.1 | In the Member State concerned months | 27 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 27 |