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HUmira in Psoriatic Arthritis

Information source: Glostrup University Hospital, Copenhagen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriatic Arthritis

Intervention: Adalimumab (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Glostrup University Hospital, Copenhagen

Official(s) and/or principal investigator(s):
Charlotte Wiell, MD, PhD, Study Chair, Affiliation: University Hospital, Gentofte, Copenhagen
Inge Juul Sørensen, MD, PhD, Principal Investigator, Affiliation: Copenhagen University Hospital, Hvidovre
Michael Sejer Hansen, MD, PhD, Principal Investigator, Affiliation: Copenhagen University Hospital at Herlev
Ole Rintek Madsen, MD, PhD, Principal Investigator, Affiliation: University Hospital, Gentofte, Copenhagen
Ole Slot, MD, Principal Investigator, Affiliation: Glostrup University Hospital, Copenhagen
Susanne J Pedersen, MD, Principal Investigator, Affiliation: Gentofte University Hospital


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.

Clinical Details

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?

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Modified Psoriatic Arthritis Response criteria (PsARC)


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


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.

Locations and Contacts

Copenhagen University Hospital, Glostrup, Glostrup, Copenhagen 2600, Denmark
Additional Information

Starting date: November 2006
Last updated: November 3, 2011

Page last updated: August 23, 2015

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