E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Psoriasis and Psoriatic Arthritis |
|
E.1.1.1 | Medical condition in easily understood language |
Psoriasis and Psoriatic Arthritis |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
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 global transcriptomic effects of apremilast in synovial biopsies of DMARD (cs and b) naïve PsA patients, obtained prior to, and 24 weeks after apremilast therapy |
|
E.2.2 | Secondary objectives of the trial |
To correlate the molecular effects of apremilast therapy to clinical and ultrasound response, with a specific attention on joints, enthesis.
Evaluate clinical response at W24, by using ACR20/50/70 response criteria.
Identify candidate synovial markers/pathways associates with response to apremilast in PsA by correlating molecular signals at baseline with the clinical response observed at week 24. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed.
• Male or non-pregnant, non-nursing female patients at least 18 years of age.
• With a diagnosis of active PsA according to CASPAR criteria
• Naïve to csDMARD and bDMARD,
• At least 1 swollen joint at screening or baseline (despite NSAIDs therapy) with ability to perform a synovial biopsy at W0.
• Concomitant oral steroids (no more than 10 mg/day of prednisolone), NSAIDs, or painkillers is permitted if started prior to the study and remain at a stable dose at least 4 weeks before the baseline.
• Allowed concomitant medications are to remain stable through week 24.
• At least one joint (small or large) to biopsy in order to get synovial tissue. Small joints must have an US scoring > 2 on grey-scale score/power Doppler. |
|
E.4 | Principal exclusion criteria |
• Contraindications for needle-arthroscopy.
• Prior use of the investigational drug (apremilast).
• Patients with hypersensitivity to apremilast or to one of its excipients
• Prior csDMARD or bDMARD therapy,
• Women who are pregnant, breastfeeding or planning on becoming pregnant for the 24 weeks of the drug administration,
• Non-menopausal women who are not using an adequate contraception method,
• Patients with conditions/concomitant diseases making them non evaluable for the primary endpoint
• Impossibility to meet specific protocol requirements (e.g. blood sampling)
• Patient is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
• Uncooperative or any condition that could make the patient potentially noncompliant to the study procedures
• Any therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before baseline.
• Any intramuscular corticosteroid injection within 4 weeks before baseline.
• A history of active tuberculosis (TB). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoints are not clinical but molecular changes in the synovium after 24 weeks of apremilast therapy |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Correlation between molecular changes and clinical changes.
Correlation between molecular changes and ultrasonography changes. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |