HUmira treatment in PSoriatic Arthritis (HUPSA) - a danish multicenter study of new imaging- and bio-markers for improved assessment of disease activity and progression and prediction of therapeutic outcome in patients with psoriatic arthritis receiving Humira. - HUPSA
- Conditions
- Psoriatic Arthritis according to the Moll and Wright diagnostic criteria.
- Registration Number
- EUCTR2006-000004-16-DK
- Lead Sponsor
- Hvidovre Hospital, Dept. of Rheumatology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 40
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method