Clinical trial NCT01465438: HUmira in Psoriatic Arthritis
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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriatic Arthritis
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: University Hospital, Gentofte, Copenhagen
name: Copenhagen University Hospital at Herlev
name: Copenhagen University Hospital, Hvidovre
First posted: 2011-11-04
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Modified Psoriatic Arthritis Response criteria (PsARC)
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Copenhagen University Hospital, Glostrup
state: Copenhagen
Study officials:
affiliation: University Hospital, Gentofte, Copenhagen
name: Charlotte Wiell, MD, PhD
role: STUDY_CHAIR
affiliation: Copenhagen University Hospital, Hvidovre
name: Inge Juul Sørensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Copenhagen University Hospital at Herlev
name: Michael Sejer Hansen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Gentofte, Copenhagen
name: Ole Rintek Madsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Glostrup University Hospital, Copenhagen
name: Ole Slot, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gentofte University Hospital
name: Susanne J Pedersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.