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

June 16, 2011
November 3, 2011
November 2006
June 2011   (final data collection date for primary outcome measure)
Modified Psoriatic Arthritis Response criteria (PsARC) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01465438 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
HUmira in Psoriatic Arthritis
Can New Imaging- and Biomarkers Improve the Assessment of Disease Activity and Progression and Predict Therapeutic Outcome in Psoriatic Arthritis Patients Receiving Adalimumab?

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Psoriatic Arthritis
Drug: Adalimumab
Adalimumab 40 mg every other week
Other Name: Humira
Experimental: Adalimumab
Responders at week 24 continue treatment with adalimumab. Non-responders at week 24 stops treatment with adalimumab.
Intervention: Drug: Adalimumab
Poggenborg RP, Wiell C, Bøyesen P, Boonen A, Bird P, Pedersen SJ, Sørensen IJ, Madsen OR, Slot O, Møller JM, Hasselquist M, Kubassova O, Østergaard 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01465438
HUPSA HUM 05-040, 2006-000004-16
Yes
Professor Mikkel Østergaard, Rheumatologic Research Unit and Department of Rheumatology, Glostrup University Hospital
Glostrup University Hospital, Copenhagen
  • University Hospital, Gentofte, Copenhagen
  • Copenhagen University Hospital at Herlev
  • Copenhagen University Hospital, Hvidovre
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
Glostrup University Hospital, Copenhagen
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP