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Clinical Trials/NCT01465438
NCT01465438
Completed
Phase 4

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

Glostrup University Hospital, Copenhagen1 site in 1 country42 target enrollmentNovember 2006
InterventionsAdalimumab

Overview

Phase
Phase 4
Intervention
Adalimumab
Conditions
Psoriatic Arthritis
Sponsor
Glostrup University Hospital, Copenhagen
Enrollment
42
Locations
1
Primary Endpoint
Modified Psoriatic Arthritis Response criteria (PsARC)
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2006
End Date
June 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Glostrup University Hospital, Copenhagen

Eligibility Criteria

Inclusion Criteria

  • Subject Population: patients with active PsA, fulfilling the following major criteria:
  • Diagnosis of PsA according to Moll and Wright criteria (Moll and Wright,
  • Clinical active disease, defined as \>2 (of 76) swollen joints and \> 2 (of 78) tender joints
  • Involvement of the hands (Clinical swelling of 1 or more finger joint and/or 1 or more 1 sausage finger)
  • Clinical indication for anti-TNF alpha therapy, according to treating physician
  • 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.

Exclusion Criteria

  • Not provided

Arms & Interventions

Adalimumab

Responders at week 24 continue treatment with adalimumab. Non-responders at week 24 stops treatment with adalimumab.

Intervention: Adalimumab

Outcomes

Primary Outcomes

Modified Psoriatic Arthritis Response criteria (PsARC)

Time Frame: 24 weeks

Study Sites (1)

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