Detecting early pre-symptomatic psoriatic arthritis in patients with skin moderate or severe psoriasis - how effective is ustekinumab (Stelara) in limiting joint disease progression and future disability?

Phase 1

• Conditions: MedDRA version: 14.1 Level: LLT Classification code 10037157 Term: Psoriasis of scalp System Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]; MedDRA version: 14.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859; MedDRA version: 14.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 14.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 14.1 Level: LLT Classification code 10063407 Term: Psoriasis genital System Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 14.1 Level: LLT Classification code 10066579 Term: Progression of psoriatic arthritis System Organ Class: 100000004859; MedDRA version: 14.1 Level: PT Classification code 10028703 Term: Nail psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Psoriatic disease (psoriasis and psoriatic arthritis).; MedDRA version: 14.1 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

• Registration Number: EUCTR2012-002640-25-GB
• Lead Sponsor: niversity of Leeds/Leeds Teaching Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-07
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified