A prospective, single-centre, feasibility study evaluating the prevalence of diagnostic clinical imaging features of subclinical enthesitis in patients with moderate to severe plaque psoriasis and the response to skin directed treatment with Ustekinumab - MUSTEK Study (Protocol Version 1.0)

niversity of Leeds/Leeds Teaching Hospitals NHS Trust0 sites30 target enrollmentJanuary 7, 2013

DrugsStelara

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Psoriatic disease (psoriasis and psoriatic arthritis).
Sponsor: niversity of Leeds/Leeds Teaching Hospitals NHS Trust
Enrollment: 30
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 7, 2013

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

niversity of Leeds/Leeds Teaching Hospitals NHS Trust

Eligibility Criteria

Inclusion Criteria

•1\. Male and female patients aged from 18 to 80 years (inclusive) 2\. A clinical diagnosis of chronic plaque psoriasis 3\. Duration of psoriasis greater than twelve months 4\. Moderate or severe skin disease (classified as a 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\. A physical ability to undergo USS, OCT and MRI scanning 8\. An ability to permit the administration of subcutaneous medication by Dr Laura Savage (PI). 9\. 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
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 27
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 3

Exclusion Criteria

•1\. Male and female patients aged 17 and under or 81 and over (inclusive) 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 scanning (e.g. pacemaker, aneurysm coil) 6\. Patients not willing to use adequate contraceptive methods 7\. Pregnancy or breast feeding 8\. Any contraindication to biologic therapy: o Active infection, including open leg ulcers, HIV, hepatitis B or C carriers o Active or latent tuberculosis o Malignancy – current, or previous within the last ten years (except basal cell carcinoma) o Severe heart failure (NYHA grade 3 or more) o Demyelinating disorders o Uncontrolled diabetes o Chronic lung disease (pulmonary fibrosis or bronchiectasis) o Previous PUVA phototherapy (\>1000 joules) 9\. History of other significant medical conditions, including: o Severe pulmonary disease (defined as requiring previous hospital admission or supplemental oxygen) o Active or severe cardiovascular disorders: uncontrolled hypertension, myocardial infarction within the previous twelve months, unstable angina within the previous six months) o Any immunodeficiency disorder o Connective tissue diseases (e.g. primary Sjogrens syndrome, systemic sclerosis, systemic lupus erythematosus, polymyositis) o Renal impairment (creatinine clearance \<45ml/min) o Abnormal liver function tests (alanine transferase \>3x upper limit of normal) o Blood disorders, i.e. neutropenia (neutrophils \<2\.0x109/l), thrombocytopenia (platelets \<125x109/l) or anaemia (haemoglobin \<8g/dl). 10\. Any forthcoming event that may interrupt participation (e.g. a holiday, elective hospital admission) lasting longer than 14 days. Whilst some of the above are absolute contraindications, physician discretion will be applied as in usual clinical practice.