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HUmira in Psoriatic Arthritis

Can New Imaging- and Biomarkers Improve the Assessment of Disease Activity and Progression and Predict Therapeutic Outcome in Psoriatic Arthritis Patients Receiving Adalimumab?

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01465438
Acronym
HUPSA
Enrollment
42
Registered
2011-11-04
Start date
2006-11-30
Completion date
2011-06-30
Last updated
2011-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis

Brief summary

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.

Interventions

DRUGAdalimumab

Adalimumab 40 mg every other week

Sponsors

University Hospital, Gentofte, Copenhagen
CollaboratorOTHER
Copenhagen University Hospital at Herlev
CollaboratorOTHER
Copenhagen University Hospital, Hvidovre
CollaboratorOTHER
Glostrup University Hospital, Copenhagen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Modified Psoriatic Arthritis Response criteria (PsARC)24 weeks

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026