HUmira in Psoriatic Arthritis

Phase 4

Completed

• Conditions: Psoriatic Arthritis
• Interventions: Drug: Adalimumab

• Registration Number: NCT01465438
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Status Verified: 2011-02
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-11-03
• Last Update Submitted: 2011-11-03
• Study First Posted: 2011-11-04
• Last Update Posted: 2011-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adalimumab	Adalimumab	Responders at week 24 continue treatment with adalimumab. Non-responders at week 24 stops treatment with adalimumab.

Primary Outcome Measures

Name	Time	Method
Modified Psoriatic Arthritis Response criteria (PsARC)	24 weeks

Trial Locations

Locations (1)

Copenhagen University Hospital, Glostrup; 🇩🇰 Glostrup, Copenhagen, Denmark