E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Psoriatic arthritis (PsA) |
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E.1.1.1 | Medical condition in easily understood language |
Psoriatic arthritis (PsA) is a chronic inflammatory disease |
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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 | 20.0 |
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 |
To evaluate the efficacy of PF-06700841 compared to placebo in subjects with active psoriatic arthritis (PsA). |
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E.2.2 | Secondary objectives of the trial |
• To evaluate the efficacy of PF-06700841 compared to placebo in subjects with active PsA who are TNFα inhibitor naïve.
• To evaluate the improvement in signs and symptoms related PsA Core Domain Set in PF-06700841 treated subjects.
• To evaluate the improvement in patient reported outcome measures related PsA Core Domain Set in PF-06700841 treated subjects.
• To evaluate the improvement in additional composite outcome measures in PF-06700841 treated subjects.
• To evaluate the safety and tolerability of PF-06700841. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female subjects between 18-75 years of age, inclusive, at time of informed consent.
• To meet the CASPAR (ClASsification criteria for Psoriatic ARthritis) criteria, a subject must have inflammatory articular disease with at least 3 points from the 5 categories, please see the categories description in protocol.
• The subject must have evidence of active arthritis as defined by having at least 3 tender/painful joints on motion and at least 3 swollen joints at both Screening and Baseline.
• The subject must have diagnosed active plaque psoriasis, with at least one psoriatic plaque or nail changes consistent with psoriasis, at both Screening and Baseline.
• Ongoing treatment with a single non-biologic DMARD (limited to methotrexate, leflunomide, sulfasalazine) during the study is allowed but is not required. Other non-biologic DMARD must be discontinued.
• Subjects who have received TNF inhibiting biologic agent must have experienced an inadequate response. Subjects could have failed no more than one TNF inhibiting biologic agent.
See section 4.1 of the Protocol for a full list of Inclusion Criteria |
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E.4 | Principal exclusion criteria |
• History of infection needing hospitalization or treatment detailed in protocol or history of an infected joint prosthesis. Any known current chronic infection or recurrent infection.
• Subjects who have undergone treatment with any IL-17 inhibitor, IL-12/23 inhibitor, or IL-23 inhibitor.
• Subjects who have undergone treatment with any Janus kinase (Jak) inhibitors, (including but not limited to tofacitinib [Xeljanz], baricitinib [Olumiant], upadacitinib, peficitinib, filgotinib).
See section 4.2 of the Protocol for a full list of Exclusion Criteria |
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E.5 End points |
E.5.1 | Primary end point(s) |
• The proportion of subjects achieving an American College of Rheumatology 20 (ACR20) response at Week 16. |
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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) |
Week 16:
• The proportion of subjects achieving an ACR20 response at Week 16 in the subgroup of subjects who are TNFα inhibitor naïve.
Assessed at all treatment timepoints:
• The proportion of subjects achieving an ACR20 response at all treatment timepoints (other than Week 16), and proportion of subjects achieving an ACR50 and ACR70 response;
• Change from baseline in the ACR response criteria components (Tender/painful joint count, Swollen joint count, Patient’s Assessment of Arthritis Pain, Patient’s Global Assessment of Arthritis, Physician’s Global Assessment of Arthritis, Health Assessment Questionnaire [HAQ] disability index [DI], and hsCRP);
• The proportion of subjects achieving a Psoriasis Area and Severity Index 75/90/100 (PASI75/90/100) response;
• Change from baseline in the enthesitis score (using the Spondyloarthritis Research Consortium of Canada [SPARCC] Enthesitis Index and Leeds Enthesitis Index);
• Change from baseline in the Dactylitis Severity Score;
• Change from baseline in the Nail Psoriasis Severity Index (NAPSI) Score.
• Change from baseline in the Patient’s Global Joint and Skin Assessment Visual Analog Scale (PGJS-VAS);
• Change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue);
Assessed at all treatment timepoints except Week 2:
• Change from baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute.
• The proportion of subjects achieving Minimal Disease Activity (MDA) and Very Low Disease Activity (VLDA) response;
• Change from baseline in the Disease Activity Index for Reactive Arthritis/PsA (DAREA/DAPSA);
• The proportion of subjects achieving the Psoriatic Arthritis Response Criteria (PsARC);
• Change from baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS).
Throughout the study:
• Incidence of adverse events (AEs), serious adverse events (SAEs) and serious infectious events (SIEs), withdrawals due to AEs and SAEs, and laboratory abnormalities, changes in vital signs, and electrocardiogram (ECG) findings throughout the study. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Individual timepoints are included in each bullet point above. |
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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 | 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) | 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 | 6 |
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 | 55 |
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 |
Belarus |
Bulgaria |
Czech Republic |
Estonia |
Hungary |
Lithuania |
Poland |
Russian Federation |
Serbia |
Slovakia |
Spain |
Ukraine |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 13 |
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 | 11 |
E.8.9.2 | In all countries concerned by the trial days | 6 |