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HUmira in Psoriatic Arthritis

NCT01465438 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2011-11-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Adalimumab

Adalimumab 40 mg every other week

Sponsors & Collaborators

  • University Hospital, Gentofte, Copenhagen

    collaborator OTHER

  • Copenhagen University Hospital at Herlev

    collaborator OTHER

  • Copenhagen University Hospital, Hvidovre

    collaborator OTHER

  • Glostrup University Hospital, Copenhagen

    lead OTHER

Principal Investigators

  • Charlotte Wiell, MD, PhD · University Hospital, Gentofte, Copenhagen

  • Inge Juul Sørensen, MD, PhD · Copenhagen University Hospital, Hvidovre

  • Michael Sejer Hansen, MD, PhD · Copenhagen University Hospital at Herlev

  • Ole Rintek Madsen, MD, PhD · University Hospital, Gentofte, Copenhagen

  • Ole Slot, MD · Glostrup University Hospital, Copenhagen

  • Susanne J Pedersen, MD · Gentofte University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01465438 on ClinicalTrials.gov