E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Psoriatic Arthritis |
Artritis psoriásica |
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E.1.1.1 | Medical condition in easily understood language |
Psoriatic Arthritis |
Artritis psoriásica |
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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 | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 100000004859 |
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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 |
Assess the long term efficacy, and safety and tolerability of ABT-122 in psoriatic arthritis (PsA) subjects on background methotrexate (MTX) who have completed Study M14-197 Phase 2 RCT. |
Evaluar la eficacia, la seguridad y la tolerabilidad a largo plazo de ABT-122 en pacientes con artritis psoriásica (Aps) y tratamiento de base con metotrexato (MTX) que finalizaron el estudio en fase II, aleatorizado y controlado, M14-197. |
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E.2.2 | Secondary objectives of the trial |
-To explore the effect of continued dosing on anti-drug antibody (ADA) profiles for ABT-122. -To explore the longer term effects of ABT-122 on function, quality of life and fatigue. |
-Estudiar el efecto de la administración continuada de ABT 122 en los perfiles de anticuerpos antimedicamentos (ACAM). -Estudiar los efectos a largo plazo de ABT-122 en la función, la calidad de vida y la fatiga. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subjects who have completed preceding Study M14-197 (ABT-122) RCT study and have not developed any discontinuation criteria, defined in Section 5.4.1 of Study M14-197. 2. If female, subject must meet one of the following criteria: ? Postmenopausal (defined as no menses for at least 1 year). ? Surgically sterile (bilateral oophorectomy or hysterectomy). ? Total abstinence from sexual intercourse as the preferred lifestyle of the subject. Periodic abstinence is not acceptable. ? Practicing appropriate birth control, from the time of enrollment in this study until at least 150 days after the last dose of study drug defined as at least TWO of the following methods of birth control: -Tubal ligation -Partner vasectomy (at least 6 months earlier) (the vasectomized male partner should be the sole partner for that female subject) -Intrauterine device (IUD) -Diaphragm, contraceptive sponge or cervical cap with spermicidal jelly or cream -Hormonal contraceptives (note, low-dose progestin-only oral contraceptives such as norethindrone 0.35 mg and lynestenol 0.5 mg are not considered adequate) -Double-barrier contraception* defined as: A male condom PLUS diaphragm or cervical cap used with spermicidal jelly or cream. * Note: A female condom and a male condom should not be used together. Also, because the contraceptive sponge has a high failure rate, particularly in multiparous females, it should not be considered an acceptable alternative. 3. Male who agrees to follow one of the protocol-specified pregnancy avoidance measures below, including refraining from donating sperm, for up to 150 days post last dose of study drug: ? Subject using condom and female partner(s) using an intrauterine device (IUD); ? Subject using condom and female partner(s) using hormonal contraceptives (oral, vaginal, parenteral or transdermal); (note, low-dose progestin-only oral contraceptives such as norethindrone 0.35 mg and lynestenol 0.5 mg are not considered adequate); ? Subject using condom and female partner(s) using double-barrier method (contraceptive sponge; diaphragm or vaginal ring with spermicidal jellies, creams, or spermicide); ? Total abstinence from sexual intercourse as the preferred lifestyle of the subject; periodic abstinence is not acceptable. 4. Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any study-specific procedures. 5. Subject is judged to be in good health as determined by the Investigator based on the results of medical history, physical examination and laboratory profile performed. |
1.Sujetos que hayan completado previamente el estudio M14-197 aleatorizado y controlado con ABT-122 y no muestren ningún criterio de interrupción, tal y como se definen en el apartado 5.4.1 del estudio M14-197. 2.Si son mujeres, deben cumplir uno de los siguientes criterios: ?ser postmenopaúsicas (definido como la ausencia de periodo durante al menos 1 año) ?Estar esterilizada quirúrgicamente (ooforectomía bilateral o histerectomía). ?Abstinencia total de mantener relaciones sexuales como estilo de vida de la paciente. La abstinencia periódica no se aceptará. ?Uso de métodos anticonceptivos adecuados desde el momento inclusión en este estudio hasta al menos 150 días después de la administración de la última dosis del fármaco del estudio, definido como al menos DOS de los siguientes: -Ligadura de trompas. -Pareja vasectomizada (al menos 6 meses antes, siempre que sea la única pareja sexual de la paciente). -Dispositivo intrauterino (DIU). -Diafragma, esponja anticonceptiva o capuchón cervical con pomada o gel espermicida. -Anticonceptivos hormonales (nótese que los anticonceptivos hormonales orales con dosis bajas de gestágeno solo, como el acetato de noretisterona 0,35 mg y linestrenol 0,5 mg, no se consideran adecuados). -Método de doble barrera*, definido como: Preservativo masculino EN COMBINACIÓN con diafragma o capuchón cervical con espermicida en pomada o gel. *Nota: no deberían emplearse a la vez un preservativo masculino y un preservativo femenino. Asimismo, puesto que la esponja anticonceptiva presenta una alta tasa de fracaso, particularmente en el caso de mujeres multíparas, no debería considerarse una alternativa aceptable. 3.Hombres que acepten seguir uno de los métodos anticonceptivos que se exponen a continuación (especificados en el protocolo) además de abstenerse de donar esperma hasta 150 días después de la última dosis del fármaco del estudio: ?uso de preservativo si su pareja (mujer) usa el dispositivo intrauterino (DIU); ?uso de preservativo si su pareja (mujer) usa anticonceptivos hormonales (orales, vaginales, parenterales o transdérmicos); (nótese que los anticonceptivos hormonales orales con dosis bajas de gestágeno solo, como el acetato de noretisterona 0,35 mg y linestrenol 0,5 mg, no se consideran adecuados); ?uso del preservativo si la pareja (mujer) usa un método de doble barrera (esponja anticonceptiva, diafragma o anillo vaginal con pomadas o geles espermicidas, o espermicida); ?abstinencia total de mantener relaciones sexuales (coito) como estilo de vida del sujeto; la abstinencia periódica no se considera aceptable. 4.Los sujetos deberán firmar y fechar voluntariamente el consentimiento informado aprobado por el CEIC antes de iniciar los procedimientos del estudio. 5.Los sujetos deberán gozar de buena salud, lo que determinará el investigador basándose en los resultados de la anamnesis, la exploración física y las pruebas analíticas. |
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E.4 | Principal exclusion criteria |
1. Pregnant or breastfeeding or plans to become pregnant during study participation. 2. Ongoing infections at Day 1 (Week 0) that have NOT been successfully treated within 14 days. 3. Anticipated requirement or receipt of any live vaccine during study participation including up to 120 days after the last dose of study drug. 4. Current enrollment in another investigational study; with the exception of Study M14-197, which is required. 5. Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to continue to receive ABT-122. |
1.Estar embarazada o en periodo de lactancia o tener previsto quedarse embarazada durante la participación en el estudio. 2.Tener infecciones en curso el día 1 (semana 0) que NO hayan respondido al tratamiento en un plazo de 14 días. 3.Recibir o esperar recibir una vacuna con microbios vivos durante la participación en el estudio y hasta 120 días después de la administración de la última dosis del fármaco del estudio. 4.Participar en otro estudio de investigación, a excepción del estudio M14-197, lo que constituye un requisito. 5.Cualquier razón que, en opinión del investigador, indique la falta de idoneidad del candidato para seguir recibiendo ABT-122. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective of Study M14-198 is to assess the long term efficacy, and the safety and tolerability of ABT-122 in PsA subjects on background methotrexate (MTX) who have completed Study M14-197 Phase2 RCT. |
Evaluar la eficacia, la seguridad y la tolerabilidad a largo plazo de ABT-122 en pacientes con artritis psoriásica (Aps) y tratamiento de base con metotrexato (MTX) que finalizaron el estudio en fase II, aleatorizado y controlado, M14-197. |
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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) |
? To explore the effect of continued dosing on anti-drug antibody (ADA) profiles for ABT-122. ? To explore the longer term effects of ABT-122 on function, quality of life and fatigue. |
-Estudiar el efecto de la administración continuada de ABT 122 en los perfiles de anticuerpos antimedicamentos (ACAM). -Estudiar los efectos a largo plazo de ABT-122 en la función, la calidad de vida y la fatiga. |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 60 |
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 |
Bulgaria |
Czech Republic |
France |
Germany |
Hungary |
Italy |
Latvia |
New Zealand |
Poland |
Romania |
Spain |
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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
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |