E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Arthritis, Psoriatic |
Artrite psoriasica |
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E.1.1.1 | Medical condition in easily understood language |
Arthritis, Psoriatic |
Artrite psoriasica |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
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 |
The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with active Psoriatic Arthritis and an inadequate response to NSAIDs and non-biologic DMARDs. |
Lo scopo di questo studio e' quello di caratterizzare la sicurezza, l'efficacia e la risposta a diverse dosi di BMS-945429 in pazienti con artrite psoriasica attiva che hanno un'insufficiente risposta ai FANS e ai farmaci non biologici DMARD. |
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E.2.2 | Secondary objectives of the trial |
1) Proportion of subjects achieving PASI 75 response rate at Weeks 16 and 24 2) Proportion of subjects achieving ACR50 and ACR70 response rate at Weeks 16 and 24 3) Proportion of subjects achieving ACR20 response rate at Week 24 4) Proportion of subjects achieving a HAQ response at Weeks 16 and 24, as measured by a reduction of at least 0.3 unit from baseline in HAQ index 5) SF-36 changes from baseline to Weeks 16 and 24 6) AEs, vital signs, physical examinations, safety lab values, and immunogenicity during double-blind period |
1) La percentuale di soggetti che raggiungono il tasso di risposta PASI 75 alle settimane 16 e 24; 2) La percentuale di soggetti che raggiungono il tasso di risposta ACR50 e ACR70 alle settimane 16 e 24; 3) La percentuale di soggetti che raggiungono il tasso di risposta ACR20 alla settimana 24; 4) La percentuale di soggetti che raggiungono la risposta HAQ alle settimane 16 e 24, come misurato da una riduzione di almeno 0,3 unità rispetto al basale dell’indice HAQ; 5) le variazioni di SF-36 dal basale alle settimane 16 e 24; 6) gli eventi avversi, i segni vitali, gli esami obiettivi, i valori di laboratorio di sicurezza e immunogenicità durante periodo in doppio cieco. |
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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 |
OTHER SUBSTUDIES: - Skin Biopsy Substudy (see section 5.4.4.9 of the protocol);- Intensive PK Sub study (see section 5.5.1 of the protocol).
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ALTRI SOTTOSTUDI: - Sotto-studio di biopsia della pelle (vedere la sezione 5.4.4.9 del protocollo); - Sotto-studio di farmacocinetica (vedere la sezione 5.5.1 del protocollo)
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E.3 | Principal inclusion criteria |
• Inadequate response to NSAID or non-biologic DMARD • Minimum of 3 swollen and 3 tender joints • Active psoriatic skin lesions over minimum 3% body surface area • hsCRP ≥ 0.3 mg/dL • Subjects must have diagnosis of active PsA by Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 12 weeks prior to screening |
• Insufficiente risposta ai FANS e/o ai DMARDs non-biologici; • Numero di articolazioni tumefatte ≥ 3 e numero di articolazioni dolenti ≥ 3; • L'area delle lesioni cutanee per AP attiva deve essere ≥ 3% della superficie corporea (BSA – Body Surface Area); • La proteina C reattiva deve avere un valore ≥ 0.3 mg/dL; • I soggetti devono avere una diagnosi di AP attiva definita secondo i criteri di classificazione CASPAR per l'AP da almeno 12 settimane prima dello screening. |
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E.4 | Principal exclusion criteria |
Previously received or currently receiving concomitant biologic therapy |
Hanno precedentemente ricevuto o stanno ricevendo una terapia biologica approvata per AP o per psoriasi. |
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E.5 End points |
E.5.1 | Primary end point(s) |
American College of Rheumatology criteria (ACR20) |
ACR 20 (Criterio dell' American College of Rheumatology) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At 16 weeks |
a 16 settimane |
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E.5.2 | Secondary end point(s) |
1) Proportion of subjects achieving PASI 75 response rate 2) Proportion of subjects achieving ACR50 and ACR70 response rate 3) Proportion of subjects achieving ACR20 response rate 4) Proportion of subjects achieving a HAQ response, as measured by a reduction of at least 0.3 unit from baseline in HAQ index 5) SF-36 changes from baseline 6) AEs, vital signs, physical examinations, safety lab values, and immunogenicity during double-blind period |
1) La percentuale di soggetti che raggiungono il tasso di risposta PASI 75; 2) La percentuale di soggetti che raggiungono il tasso di risposta ACR50 e ACR70; 3) La percentuale di soggetti che raggiungono il tasso di risposta ACR20; 4) La percentuale di soggetti che raggiungono la risposta HAQ; come misurato da una riduzione di almeno 0,3 unità rispetto al basale dell’indice HAQ; 5) le variazioni di SF-36 dal basale; 6) gli eventi avversi, i segni vitali, gli esami obiettivi, i valori di laboratorio di sicurezza e immunogenicità durante periodo in doppio cieco. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 16 and Week 24 |
Alle settimane 16 e 24 |
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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 | 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 | 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 | 30 |
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 |
Canada |
Mexico |
Russian Federation |
South Africa |
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
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 30 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 30 |
E.8.9.2 | In all countries concerned by the trial days | 0 |