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HUmira in Psoriatic Arthritis (HUPSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01465438
Recruitment Status : Completed
First Posted : November 4, 2011
Last Update Posted : November 4, 2011
University Hospital, Gentofte, Copenhagen
Copenhagen University Hospital at Herlev
Copenhagen University Hospital, Hvidovre
Information provided by:
Glostrup University Hospital, Copenhagen

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.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Drug: Adalimumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2006
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: Adalimumab
Responders at week 24 continue treatment with adalimumab. Non-responders at week 24 stops treatment with adalimumab.
Drug: Adalimumab
Adalimumab 40 mg every other week
Other Name: Humira

Primary Outcome Measures :
  1. Modified Psoriatic Arthritis Response criteria (PsARC) [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01465438

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Copenhagen University Hospital, Glostrup
Glostrup, Copenhagen, Denmark, 2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
University Hospital, Gentofte, Copenhagen
Copenhagen University Hospital at Herlev
Copenhagen University Hospital, Hvidovre
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Study Chair: Charlotte Wiell, MD, PhD University Hospital, Gentofte, Copenhagen
Principal Investigator: Inge Juul Sørensen, MD, PhD Copenhagen University Hospital, Hvidovre
Principal Investigator: Michael Sejer Hansen, MD, PhD Copenhagen University Hospital at Herlev
Principal Investigator: Ole Rintek Madsen, MD, PhD University Hospital, Gentofte, Copenhagen
Principal Investigator: Ole Slot, MD Glostrup University Hospital, Copenhagen
Principal Investigator: Susanne J Pedersen, MD Gentofte University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Professor Mikkel Østergaard, Rheumatologic Research Unit and Department of Rheumatology, Glostrup University Hospital Identifier: NCT01465438     History of Changes
Other Study ID Numbers: HUPSA HUM 05-040
2006-000004-16 ( EudraCT Number )
First Posted: November 4, 2011    Key Record Dates
Last Update Posted: November 4, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
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Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Anti-Inflammatory Agents
Antirheumatic Agents