Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
42 participants
INTERVENTIONAL
2006-11-30
2011-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Adalimumab
Responders at week 24 continue treatment with adalimumab. Non-responders at week 24 stops treatment with adalimumab.
Adalimumab
Adalimumab 40 mg every other week
Interventions
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Adalimumab
Adalimumab 40 mg every other week
Other Intervention Names
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Eligibility Criteria
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Inclusion 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.
18 Years
80 Years
ALL
No
Sponsors
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University Hospital, Gentofte, Copenhagen
OTHER
Copenhagen University Hospital at Herlev
OTHER
Copenhagen University Hospital, Hvidovre
OTHER
Glostrup University Hospital, Copenhagen
OTHER
Responsible Party
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Rheumatologic Research Unit and Department of Rheumatology, Glostrup University Hospital
Principal Investigators
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Charlotte Wiell, MD, PhD
Role: STUDY_CHAIR
University Hospital, Gentofte, Copenhagen
Inge Juul Sørensen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Copenhagen University Hospital, Hvidovre
Michael Sejer Hansen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Copenhagen University Hospital at Herlev
Ole Rintek Madsen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Gentofte, Copenhagen
Ole Slot, MD
Role: PRINCIPAL_INVESTIGATOR
Glostrup University Hospital, Copenhagen
Susanne J Pedersen, MD
Role: PRINCIPAL_INVESTIGATOR
Gentofte University Hospital
Locations
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Copenhagen University Hospital, Glostrup
Glostrup Municipality, Copenhagen, Denmark
Countries
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References
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Poggenborg RP, Wiell C, Boyesen P, Boonen A, Bird P, Pedersen SJ, Sorensen IJ, Madsen OR, Slot O, Moller JM, Hasselquist M, Kubassova O, Ostergaard M. No overall damage progression despite persistent inflammation in adalimumab-treated psoriatic arthritis patients: results from an investigator-initiated 48-week comparative magnetic resonance imaging, computed tomography and radiography trial. Rheumatology (Oxford). 2014 Apr;53(4):746-56. doi: 10.1093/rheumatology/ket426. Epub 2013 Dec 24.
Other Identifiers
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2006-000004-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
HUPSA HUM 05-040
Identifier Type: -
Identifier Source: org_study_id