MUSTEK Study (Protocol Version 1.0)

• Research type

  Research Study

• Full title

  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

• IRAS ID

  94533

• Contact name

  Laura J Savage

• Eudract number

  2012-002640-25

• ISRCTN Number

  ISRCTN18043449

• Research summary

  Approximately 10% of cases of psoriasis evolve into psoriatic arthritis, which can be a destructive and disabling condition. Since the biologic agents, including stekinumab, exhibit efficacy in psoriatic arthritis, dermatologists now speculate that early intervention with these agents in psoriasis may prevent the evolution of subclinical disease into frank psoriatic arthritis. No data has been forthcoming for any drug which shows that the treatment of active skin disease also suppresses the features of subclinical systemic disease. The demonstration of such would represent a first for biologic therapy in psoriasis. Ustekinumab administration in our study shall be concordant with the standard dosing regimen as is used currently for therapy in psoriasis. We aim to treat patients for six months, which is sufficient time for suppression of subclinical enthesitis and improvement in nail psoriasis (a prognostic marker for joint disease). Following recruitment and informed consent, patients will be reviewed by a Dermatologist at a frequency identical to current practice for patients receiving biologic therapies. Appointments will be longer, as patients will be required to undergo a series of additional imaging investigations, namely musculoskeletal ultrasound (USS)of the peripheral joints (ankles, feet, wrists, fingers) and Optical Coherence Tomography or OCT (similar to USS, but more detailed) of the nails, plus whole body magnetic resonance imaging (MRI). All three investigations shall be performed at baseline and at six months (end of study), and OCT and USS will be performed at three months in addition. Each visit is expected to be approximately two hours in duration.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  12/YH/0483

• Date of REC Opinion

  8 Jan 2013

• REC opinion

  Further Information Favourable Opinion