A study of pre-clinical joint disease in psoriasis and the imaging response to ustekinumab

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18043449

Enrollment

Registered

2012-09-19

Start date

2012-10-01

Completion date

Unknown

Last updated

2020-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic disease (psoriasis and psoriatic arthritis) Skin and Connective Tissue Diseases Psoriasis

Interventions

Participants are randomised to: Methotrexate - the current first-line standard tablet treatment for moderate to severe psoriasis Ustekinumab (IMP) ? anti-IL12/23 p40

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: 1. Patients aged 17 or under, or 81 and over 2. Psoriasis of mild to moderate psoriasis (PASI1000 joules) 9. History of other significant medical conditions, including: 9.1. Severe pulmonary disease (defined as requiring previous hospital admission or supplemental oxygen) 9.2. Active or severe cardiovascular disorders: uncontrolled hypertension, myocardial infarction within the previous twelve months, unstable angina within the previous six months) 9.3. Any immunodeficiency disorder 9.4. Connective tissue diseases (e.g. primary Sjogrens syndrome, systemic sclerosis, systemic lupus erythematosus, polymyositis) 9.5. Renal impairment (creatinine clearance 3x upper limit of normal) 9.7. Blood disorders, i.e. thrombocytopenia (platelets <125x109/l), neutropenia (neutrophils <2.0x109/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

Design outcomes

Primary

Measure	Time frame
To assess the change in subclinical enthesitis from baseline in patients with psoriasis treated for 24 weeks with ustekinumab for their skin disease	—

Secondary

Measure	Time frame
1. To assess the feasibility of a full randomized controlled trial (RCT) comparing ustekinumab with first line systemic therapies for the management of subclinical psoriatic joint disease in patients with moderate or severe psoriasis. 2. To estimate the baseline prevalence of peripheral subclinical enthesitis in systemic and biologic treatment-naïve patients with plaque psoriasis, recruited from a new-patient psoriasis clinic, with a PASI score greater than 10 and no symptoms of joint disease (as assessed by the CASPAR criteria) at presentation. 3. To estimate the baseline prevalence of subclinical axial arthropathy in systemic and biologic treatment-naïve patients with plaque psoriasis, recruited from a new-patient psoriasis clinic, with a PASI score greater than 10 and no symptoms of joint disease (as assessed by the CASPAR criteria) at presentation. 4. To assess the change in subclinical peripheral and axial inflammatory joint disease from baseline in patients with psoriasis treated for 24 weeks with ustekinumab for their skin disease 5. To establish if a relationship exists between the change from baseline in any routine clinical scoring measures and the change in subclinical enthesopathy on ultrasound after treatment with ustekinumab: 5.1. Skin disease severity: PASI score 5.2. Skin disease extent: BSA measurement (expressed as a percentage) 5.3. Psychosocial impact: DLQI score 5.4. Nail disease severity: NAPSI score 6. To evaluate whether there is an association between the pattern of plaque psoriasis (e.g. scalp disease) in systemic and biologic naïve patients and the severity of subclinical enthesopathy before treatment. 7. To validate the utility of optical coherence tomography in the assessment of subclinical nail disease in patients with psoriasis, compared to ultrasound, in terms of:	—

Measure

Time frame

1. To assess the feasibility of a full randomized controlled trial (RCT) comparing ustekinumab with first line systemic therapies for the management of subclinical psoriatic joint disease in patients with moderate or severe psoriasis. 2. To estimate the baseline prevalence of peripheral subclinical enthesitis in systemic and biologic treatment-naïve patients with plaque psoriasis, recruited from a new-patient psoriasis clinic, with a PASI score greater than 10 and no symptoms of joint disease (as assessed by the CASPAR criteria) at presentation. 3. To estimate the baseline prevalence of subclinical axial arthropathy in systemic and biologic treatment-naïve patients with plaque psoriasis, recruited from a new-patient psoriasis clinic, with a PASI score greater than 10 and no symptoms of joint disease (as assessed by the CASPAR criteria) at presentation. 4. To assess the change in subclinical peripheral and axial inflammatory joint disease from baseline in patients with psoriasis treated for 24 weeks with ustekinumab for their skin disease 5. To establish if a relationship exists between the change from baseline in any routine clinical scoring measures and the change in subclinical enthesopathy on ultrasound after treatment with ustekinumab: 5.1. Skin disease severity: PASI score 5.2. Skin disease extent: BSA measurement (expressed as a percentage) 5.3. Psychosocial impact: DLQI score 5.4. Nail disease severity: NAPSI score 6. To evaluate whether there is an association between the pattern of plaque psoriasis (e.g. scalp disease) in systemic and biologic naïve patients and the severity of subclinical enthesopathy before treatment. 7. To validate the utility of optical coherence tomography in the assessment of subclinical nail disease in patients with psoriasis, compared to ultrasound, in terms of:

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026