ISRCTN18043449
Completed
Phase 4
A prospective, single-centre, open-label, feasibility study evaluating the prevalence of diagnostic clinical imaging features of subclinical enthesitis in patients with moderate to severe plaque psoriasis and the impact on the MUSculoskeletal system of skin-directed therapy with usTEKinumab
niversity of Leeds (UK)0 sites73 target enrollmentSeptember 19, 2012
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Psoriatic disease (psoriasis and psoriatic arthritis)
- Sponsor
- niversity of Leeds (UK)
- Enrollment
- 73
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
2019 results in https://www.ncbi.nlm.nih.gov/pubmed/30468001(added 31/12/2019)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male and female patients aged 18\-80 years
- •2\. Diagnosis of plaque psoriasis (dermatologist confirmed)
- •3\. Duration of psoriasis greater than twelve months
- •4\. Moderate or severe disease \[Psoriasis Area and Severity Index (PASI score \>10\)]
- •5\. No prior treatment with systemic or biologic agents
- •6\. No current or prior symptoms of psoriatic arthritis (or arthralgia/ articular symptoms)
- •7\. Evidence on screening ultrasound of subclinical enthesitis (GUESS score \>12\)
- •8\. All male and female subjects biologically capable of having children must agree to use at least one reliable method of contraception for the duration of the study and for 24 weeks after the end of the study. Acceptable methods of contraception are surgical sterilization, oral, implantable or injectable hormonal methods, intrauterine devices or barrier contraceptives
Exclusion Criteria
- •1\. Patients aged 17 or under, or 81 and over
- •2\. Psoriasis of mild to moderate psoriasis (PASI\<10\)
- •3\. Previous treatment with any systemic or biologic agents (for psoriasis or any other indication)
- •4\. Patients unable or not willing to attend all imaging, serological and clinical assessments
- •5\. Any contraindication to MRI (e.g. pacemaker, aneurysm coil)
- •6\. Patients not willing to use adequate contraception
- •7\. Pregnancy or breast feeding
- •8\. Any contraindication to systemic or biologic therapy:
- •8\.1\. Active infection, including open leg ulcers, HIV, hepatitis B or C carriers
- •8\.2\. Active or latent tuberculosis
Outcomes
Primary Outcomes
Not specified
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