Can we predict which patients with psoriatic arthritis will respond to treatment using precision medicine?
- Conditions
- Arthritis that affects some people with the skin condition psoriasisMusculoskeletal DiseasesPsoriatic and enteropathic arthropathies
- Registration Number
- ISRCTN17228602
- Lead Sponsor
- niversity of Oxford
- Brief Summary
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37770264/ (added 29/09/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 424
Current inclusion criteria as of 15/08/2022:
1. Participant is willing and able to give informed consent for participation in the study
2. Male or female, age 18 years or over
3. Diagnosis of PsA confirmed by the CASPAR criteria
4. Is planned to have biologic therapy for psoriatic arthritis using NICE/SMC criteria (failure of =2 csDMARDs and =3 tender and =3 swollen joints)
_____
Previous inclusion criteria:
1. Participant is willing and able to give informed consent for participation in the study
2. Male or female, age 18 years or over
3. Diagnosis of PsA confirmed by the CASPAR criteria
4. Is planned to have biologic therapy for psoriatic arthritis using NICE/SMC criteria (failure of >=2 csDMARDs and >=3 tender/swollen joints)
1. Contraindications to either TNF inhibitor or secukinumab:
1.1. History of previous demyelinating disease including multiple sclerosis
1.2. Heart failure (NYHA class 3 or 4)
1.3. Serious infections: active tuberculosis (TB), chronic viral infections (including hepatitis B, C and HIV), recent serious bacterial infections
1.4. Latent TB unless they have received appropriate anti-tuberculous treatment as per local guidelines
1.5. Active symptomatic inflammatory bowel disease
1.6. History of cancer in the last 5 years, other than non-melanoma skin cell cancers cured by local resection or carcinoma in situ
1.7. Hypersensitivity to active ingredient or excipients
2. Current or previous treatment with biologic DMARDs or targeted synthetic DMARDs
3. Use of investigational therapies within 1 month or 5 half-lives (whichever is longer) of baseline
4. Women who are pregnant, lactating or planning pregnancy during the following 12 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method