TOCILIZUMAB for Psoriatic arthritis | Rheumatoid arthritis

Inclusion criteria

• {"criterion_text":"- Adult patients (≥18 years old), no upper age limit;\n- Patient must fulfil either European Alliance of Associations for Rheumatology (EULAR)/Albumin: Creatinine Ratio (ACR) classification criteria for the diagnosis of Rheumatoid Arthritis, or Classification Criteria of Psoriatic Arthritis (CASPAR);\n- Current treatment with any approved Tumour Necrosis Factor inhibitors (TNFis)\n- Active arthritis as defined by: •\tDAS28 score > 3.2 for Rheumatoid Arthritis •\tDisease Activity in Psoriatic Arthritis (DAPSA) >14 for Psoriatic Arthritis\n- Signed informed consent"}

Exclusion criteria

• {"criterion_text":"- Contraindications to any of the biologic treatment e.g. active infection;\n- Sepsis of a prosthetic joint within 12 months or indefinitely if the joint remains in situ\n- Known HIV or hepatitis B/C infection (hepatitis B screening test must be performed at or in the preceding 3 months of screening visit)\n- Malignancy (other than basal cell carcinoma) within the last 10 years\n- New York Heart Association (NYHA) grade 3 or 4 congestive cardiac failure\n- Demyelinating disease\n- Any other contra-indication to the study medications as detailed in their summaries of product characteristics (SmPC), including low IgG levels at clinician’s discretion\n- Receipt of live vaccine <4 weeks prior to first infusion\n- Major surgery in 3 months prior to first infusion\n- Presence of a transplanted organ (with the exception of a corneal transplant >3 months prior to screening)\n- Known recent substance abuse (drug or alcohol)\n- Previous treatment with any IL-6is (tocilizumab or sarilumab)\n- Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period\n- Patients currently recruited to other clinical trial(s) involving an Investigational Medicinal Pproduct (IMP), except any observational follow-up periods not involving an IMP)\n- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study\n- Women who are pregnant or breast-feeding\n- Women of child-bearing potential, or males whose partners are women of child-bearing potential, unwilling to use effective contraception during the study and for at least 3 months after stopping study treatment\n- History of or current primary inflammatory joint disease or primary autoimmune disease other than RA\n- Intra articular or parenteral corticosteroids ≤ 4 weeks prior Visit 2\n- Oral prednisolone more than 10mg per day or equivalent ≤ 4 weeks prior to Visit 2\n- Active infection\n- Septic arthritis within a native joint within the last 12 months"}

Primary endpoints

• {"endpoint_text":"- Proportion of patients who achieve disease remission at week 24 will be the primary endpoint. Remission will be defined by: •\tClinical Disease Activity Index (CDAI) 2.8 or < 2.8 in RA •\tDAPSA <4 in PsA.","definition_or_measurement_approach":"Remission defined as Clinical Disease Activity Index (CDAI) ≤ 2.8 for Rheumatoid Arthritis and DAPSA <4 for Psoriatic Arthritis; measured at week 24 (proportion of patients achieving remission)."}

Secondary endpoints

• {"endpoint_text":"- To provide proof-of-principle validation of the efficacy of combining TNF and IL-6 inhibitors achieve higher remission than current therapies in RA and PsA.","definition_or_measurement_approach":"Comparative proof-of-principle assessment of remission rates (as defined for the primary endpoint) versus current therapies."}
• {"endpoint_text":"- To provide preliminary safety and tolerability data on the selected combination therapy and improvement in disease activity as measured by validated outcome measures.","definition_or_measurement_approach":"Safety assessed by number of SAEs, AEs, AESIs and withdrawals due to SAEs/AEs/AESIs; disease activity improvement measured using validated outcome measures (e.g. ACR/EULAR responses, CDAI, DAPSA, mHAQ, PASI where applicable)."}

Spain

Earliest CTIS Part Ii Submission Date

27-05-2025

Latest Decision Or Authorization Date

14-07-2025

Processing Time Days

48

Number Of Sites

2

Number Of Participants

10

Primary sponsor

Full Name

Cardiff University

Organisation Type

Educational Institution

Country Of Registered Address

United Kingdom