E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 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 |
To evaluate the efficacy of guselkumab treatment in participants with active PsA and IR and/or intolerance to a prior anti-TNF by assessing the reduction in signs and symptoms of PsA. |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the efficacy of guselkumab on additional measures of signs and symptoms of PsA, psoriasis, and patient well-being. - To evaluate the safety of guselkumab in participants with active PsA. - To evaluate the pharmacokinetics and immunogenicity of guselkumab in participants with active PsA. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Be at least 18 years of age. - Have a diagnosis of PsA for at least 6 months prior to the first administration of study intervention and meet ClASsification criteria for Psoriatic ARthritis criteria at screening. - Have active PsA as defined by: a. At least 3 swollen joints and at least 3 tender joints at screening and at baseline AND b. CRP ≥0.3 mg/dL at screening from the central laboratory. NOTE: A 1-time repeat assessment of CRP level is allowed during the 6-week screening phase and the investigator may consider the participant eligible if the test result is within acceptable range on repeat testing in the central laboratory. - Have at least 1 of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis. - Have an inadequate response and/or intolerance to anti-TNFα therapy, defined as presence of active PsA despite previous treatment with one prior anti-TNFα agent. Participants may meet either one or both of the following criteria: a. Lack of benefit of no more than one prior anti-TNFα therapy, as documented in the patient history by the treating physician, after at least 12 weeks of etanercept, adalimumab, golimumab, or certolizumab pegol therapy and/or at least a 14-week dosage regimen of infliximab. Documented lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity AND/OR b. Intolerance to no more than one prior anti-TNFα therapy, as documented in the patient history by the treating physician, to etanercept, adalimumab, golimumab, certolizumab pegol, or infliximab.
For the complete overview of the inclusion criteria, please refer to section 5.1 of the protocol
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E.4 | Principal exclusion criteria |
- Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy in the treatment of PsA, including but not limited to rheumatoid arthritis, ankylosing spondylitis/non-radiographic axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease. - Has received more than 1 prior anti-TNFα agent. - Has received an anti-TNFα agent within the following timeframes: 1. Infliximab or golimumab, within 8 weeks prior to the first administration of study intervention. b. Golimumab SC, adalimumab or certolizumab pegol, within 6 weeks prior to the first administration of study intervention. c. Etanercept within 4 weeks prior to the first administration of study intervention. - Has previously received any biologic treatment other than an anti-TNFα agent including, but not limited to, guselkumab, ustekinumab, secukinumab, tildrakizumab, ixekizumab,brodalumab, risankizumab or other investigative biologic treatment.
For the complete overview of the exclusion criteria, please refer to section 5.2 of the protocol |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of participants who achieve an ACR 20 response at Week 24 |
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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) |
- Proportion of participants who achieve a psoriasis response of IGA psoriasis score of 0 or 1 AND ≥2-grade reduction from baseline at Week 24 among the participants with ≥3% BSA psoriatic involvement and an IGA score of ≥2 at baseline - Proportion of participants who achieve PASI 90 response at Week 24 among the participants with ≥3% BSA psoriatic involvement and an IGA score of ≥2 at baseline - Change from baseline in HAQ-DI at Week 24 - Change from baseline in the SF-36 PCS at Week 24 - Change from baseline in Functional Assessment of Chronic Illness Therapy – fatigue score at Week 24 - Proportion of participants achieving minimal disease activity at Week 24 - Proportion of participants who achieve ACR 20 response at Week 16 Proportion of participants who achieve ACR 50 response at Week 16 - Proportion of participants who achieve ACR 50 response at Week 24 - Proportion of participants who achieve ACR 70 response at Week 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 | 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 | No |
E.6.11 | Pharmacogenomic | Yes |
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 | Yes |
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 | 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 | 16 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 59 |
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 |
Malaysia |
Ukraine |
Australia |
Israel |
Russian Federation |
Turkey |
United States |
Czechia |
Hungary |
Poland |
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E.8.7 | Trial has a data monitoring committee | No |
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 | 11 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 4 |