Psoriatic Arthritis according to the Moll and Wright diagnostic criteria.
Conditions
Interventions
Product Name: Humira
Product Code: Adalimumab
Pharmaceutical Form: Injection*
Sponsors
Hvidovre Hospital, Dept. of Rheumatology
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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. ;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. | — |
Countries
Denmark
Outcome results
None listed