HUmira in Psoriatic Arthritis (HUPSA)
Psoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis, which has a estimated prevalence of 0.3 - 1 %. The clinical course varies, but PsA is often a progressive, erosive arthritis causing severe disability and increased mortality.
The biologic treatment infliximab and etanercept have recently been introduced for treatment of PsA and psoriasis, and current data indicate a higher efficacy than with previously available therapies. No clinical trials on adalimumab in PsA are yet published (2005), but preliminary data are encouraging. The improved treatment options have increased the need for sensitive methods for diagnosis, monitoring and prognostication of PsA, so that the efficient therapies can be initiated at the optimal time point and monitored optimally. Ultrasonography (US) and magnetic resonance imaging (MRI) and a number of biomarkers are promising, but not yet sufficiently studied, methods for this.
The hypothesis is that adalimumab will be an effective treatment option for PsA. Novel imaging- and biomarkers can provide additional information, compared to clinical measures and radiography, concerning activity, destructive progression and prediction of therapeutic response in PsA patients receiving adalimumab. The perspective is a potential improvement in diagnosis, monitoring and prognostication of patients with PsA.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Can New Imaging- and Biomarkers Improve the Assessment of Disease Activity and Progression and Predict Therapeutic Outcome in Psoriatic Arthritis Patients Receiving Adalimumab?|
- Modified Psoriatic Arthritis Response criteria (PsARC) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Responders at week 24 continue treatment with adalimumab. Non-responders at week 24 stops treatment with adalimumab.
Adalimumab 40 mg every other week
Other Name: Humira
|Copenhagen University Hospital, Glostrup|
|Glostrup, Copenhagen, Denmark, 2600|
|Study Chair:||Charlotte Wiell, MD, PhD||University Hospital, Gentofte, Copenhagen|
|Principal Investigator:||Inge Juul Sørensen, MD, PhD||Copenhagen University Hospital, Hvidovre|
|Principal Investigator:||Michael Sejer Hansen, MD, PhD||Copenhagen University Hospital at Herlev|
|Principal Investigator:||Ole Rintek Madsen, MD, PhD||University Hospital, Gentofte, Copenhagen|
|Principal Investigator:||Ole Slot, MD||Glostrup University Hospital, Copenhagen|
|Principal Investigator:||Susanne J Pedersen, MD||Gentofte University Hospital|