E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Consecutive patients with PsA and with clinically active peripheral disease (arthritis, tenosynovitis, dactylitis and/or enthesitis) |
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E.1.1.1 | Medical condition in easily understood language |
Consecutive patients with PsA and with clinically active peripheral disease (arthritis, tenosynovitis, dactylitis and/or enthesitis) |
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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 test the differences in change of PsASon22 and
PsASon13 scores after treatment with Apremilast
between patients reaching low disease activity or
remission (DAPSA≤14) and patients not reaching this
target (DAPSA>14) |
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E.2.2 | Secondary objectives of the trial |
1. To test the convergent construct validity of PsASon22 and PsASon13 US scores by correlating them with clinical composite scores.
2. To test sensitivity to change of the PsASon22 and PsASon13 US scores, assessing them at multiple time points
3. To test the inter-reader and intra-reader reliability of the PsASon22 and PsASon13 US scores.
4. To test differences in the change of PsASon22 and PsASon13 scores in PsA patients with high (DAPSA>28) compared to moderate (DAPSA>14-≤28) disease activity at baseline. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female patient ≥18 years and <90 years of age
2. PsA according to CASPAR criteria
3. Peripheral manifestation (arthritis, tenosynovitis, dactylitis and/or enthesitis)
4. Active disease as defined by an DAPSA >14 and clinical indication for treatment with Apremilast (as per approved indication for PsA, including failure to respond to methotrexate)
5. Written informed consent
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E.4 | Principal exclusion criteria |
1. Inability to perform US at any site included in the PsASon22 or PsASon13 score (f.e. due to complete destruction of a joint)
2. Planned surgery within the study period or history of surgery of any of the joints to be investigated clinically or by sonography.
3. Contraindication to Apremilast (as per patient information leaflet)
4. Current severe medical illness requiring hospitalization
5. Pregnancy or lactation
6. Inability of the patient to follow the treatment protocol
7. Fulfillment of the MDA Criteria or DAPSA≤14
8. Current treatment with any investigational drug
9. Current treatment with glucocorticoids at a prednisone equivalent >10mg
10. Change, including dosage changes or discontinuation, of csDMARD treatment in the last 4 weeks before baseline
11. Current bDMARD, tsDMARD treatment
12. Prior bDMARD or tsDMARD treatment without a minimal washout period before baseline (for drug specific minimal washout periods see Table 1)
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E.5 End points |
E.5.1 | Primary end point(s) |
To test the change of PsASon22 and PsASon13 scores in PsA patients undergoing treatment with Apremilast wthin 24 weeks |
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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 test the convergent construct validity of PsASon22 and PsASon13 ultrasound scores by correlating them with clinical composite scores.
2. To test the reliability of the PsASon22 and PsASon13 ultrasound scores.
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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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 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
| 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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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
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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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |