Psoriatic Arthritis Clinical Trial
— HUPSAOfficial title:
Can New Imaging- and Biomarkers Improve the Assessment of Disease Activity and Progression and Predict Therapeutic Outcome in Psoriatic Arthritis Patients Receiving Adalimumab?
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.
Status | Completed |
Enrollment | 42 |
Est. completion date | June 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: Subject Population: patients with active PsA, fulfilling the following major criteria: 1. Diagnosis of PsA according to Moll and Wright criteria (Moll and Wright, 2. Clinical active disease, defined as >2 (of 76) swollen joints and > 2 (of 78) tender joints 3. Involvement of the hands (Clinical swelling of 1 or more finger joint and/or 1 or more 1 sausage finger) 4. Clinical indication for anti-TNF alpha therapy, according to treating physician 5. Among other issues: Age >18 years; adequate birth control; no contraindications for anti-TNF alpha-therapy, no previous anti-TNF alpha-therapy, no other significant dermatological disorders than psoriasis. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Copenhagen University Hospital, Glostrup | Glostrup | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Glostrup University Hospital, Copenhagen | Copenhagen University Hospital at Herlev, Copenhagen University Hospital, Hvidovre, University Hospital, Gentofte, Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Modified Psoriatic Arthritis Response criteria (PsARC) | 24 weeks | No |
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