HUmira in Psoriatic Arthritis

Psoriatic Arthritis Clinical Trial

— HUPSA  

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01465438
• Other study ID #: HUPSA HUM 05-040
• Secondary ID: 2006-000004-16
• Status: Completed
• Phase: Phase 4
• First received: June 16, 2011
• Last updated: November 3, 2011
• Start date: November 2006
• Est. completion date: June 2011

Study information

• Verified date: February 2011
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Abbott Laboratories A/S
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• Adalimumab
Adalimumab 40 mg every other week

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital, Glostrup	Glostrup	Copenhagen

Sponsors (4)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen	Copenhagen University Hospital at Herlev, Copenhagen University Hospital, Hvidovre, University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Psoriatic Arthritis Response criteria (PsARC)		24 weeks	No