Arthritis that affects some people with the skin condition psoriasis Musculoskeletal Diseases Psoriatic and enteropathic arthropathies
Conditions
Interventions
All patients will be treated with a biologic drug (TNF inhibitors (adalimumab) or IL-17A inhibitors (secukinumab) in keeping with routine clinical practice. At present both TNF inhibitors and IL-17 i
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 999 Years
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response as measured by the minimal disease activity (MDA) criteria at baseline and week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical disease pattern at baseline measured by the minimal disease activity (MDA) criteria 2. Immunophenotype data at baseline measuring activated Th17 and intracellular levels of IL-17 3. Activated Th17 proportion and intracellular levels of IL-17 at baseline and week 24 4. Clinical response as measured by the minimal disease activity (MDA) criteria at week 12/16 and week 24 5. Cell-specific transcriptomic data and whole blood transcriptomes from samples collected at baseline and week 24 | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactLaura Coates
Outcome results
None listed