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HUmira in Psoriatic Arthritis (HUPSA)

This study has been completed.
Sponsor:
Collaborators:
University Hospital, Gentofte, Copenhagen
Copenhagen University Hospital at Herlev
Copenhagen University Hospital, Hvidovre
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01465438
First received: June 16, 2011
Last updated: November 3, 2011
Last verified: February 2011
History of Changes
  Purpose

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 Intervention Phase
Psoriatic Arthritis
 Drug: Adalimumab
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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?

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • Modified Psoriatic Arthritis Response criteria (PsARC) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: November 2006
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465438

Locations
Denmark
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
Investigators
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
  More Information

No publications provided

Responsible Party: Professor Mikkel Østergaard, Rheumatologic Research Unit and Department of Rheumatology, Glostrup University Hospital
ClinicalTrials.gov Identifier: NCT01465438     History of Changes
Other Study ID Numbers: HUPSA HUM 05-040, 2006-000004-16
Study First Received: June 16, 2011
Last Updated: November 3, 2011
Health Authority: Denmark: Abbott Laboratories A/S

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
 Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 18, 2013