HUmira in Psoriatic Arthritis (HUPSA)

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.

Study Overview

• Status: Completed
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Drug: Adalimumab

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen
    • Glostrup, Copenhagen, Denmark, 2600
      • Copenhagen University Hospital, Glostrup

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Humira

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Modified Psoriatic Arthritis Response criteria (PsARC)	24 weeks

Collaborators and Investigators

• Sponsor: Glostrup University Hospital, Copenhagen
• Collaborators: Copenhagen University Hospital at Herlev; University Hospital, Gentofte, Copenhagen; 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: June 16, 2011
• First Submitted That Met QC Criteria: November 3, 2011
• First Posted (ESTIMATE): November 4, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): November 4, 2011
• Last Update Submitted That Met QC Criteria: November 3, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: HUPSA HUM 05-040; 2006-000004-16 (EUDRACT_NUMBER)