E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Psoriatic Arthritis according to the Moll and Wright diagnostic criteria. |
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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 |
With optimal imaging methods (MRI, CT and US) to assess the efficacy of adalimumab to suppress inflammatory changes (e.g. synovitis, tenosynovitis, enthesitis) and stop progression in bone damage in patients with PsA. |
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E.2.2 | Secondary objectives of the trial |
Identification of clinical useful imaging- and bio- markers for improved assessment of disease activity and progression in PsA patients receiving adalimumab. Identification of candidate imaging- and bio- markers for improved prediction of therapeutic response in PsA patients receiving adalimumab. Investigation of the clinical effect (as measured by PsARC, ACR and PASI response endpoints) of adalimumab in patients with PsA. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1.Diagnosis of PsA according to Moll and Wright diagnostic criteria. 2.Clinical active disease, defined as ³3 (of 76) swollen joints and ³ 3 (of 78) tender joints. 3.Involvement of the hands (Clinical swelling of ³ 1 finger joint and/or ³1 sausage finger). 4.Clinical indication for anti-TNFa therapy, according to treating physician. 5.Adequate birth control. |
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E.4 | Principal exclusion criteria |
1.Pregnant or breast-feeding women. 2.No prior anti-TNFa-therapy. 3.No treatment with other DMARDs than MTX later than 4 weeks before inclusion. 4.No steroids later than 4 weeks before inclusion. 5.No contraindikations for MRI. 6.No other significant dermatological disorder tha psoriasis. 7.No PUVA treatment or other UVA treatment later than 2 weeks before inclusion. 8.No contraindications for anti-TNFa-therapy.
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E.5 End points |
E.5.1 | Primary end point(s) |
The included patients will be divided in non-responders and responders according to fulfilment of the PsARC criteria at week 24 (primary clinical endpoint). Psoriatic Arthritis Response Criteria: Improvement from baseline in two of the following criteria, one which should be a joint-score:
● Physians Globale Diseaseevaluation (20% improvement in a 100 mm visual analog scale) ● Patients Globale Diseaseevaluation (20% improvement in a 100 mm visual analog scale) ● Tender joints (30% improvement) ● Swollen joints (30% improvement)
No deterioration in any of the criteria.
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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 | Yes |
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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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.8.5 | 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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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Non-responders will discontinue trial-treatment at week 24. Responders will continue trial-treatment til week 48. All will follow the 48 week program for imaging- and bio-markers. |
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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 | |