Testing the safety and efficacy of combining biologic drugs in Rheumatoid and Psoriatic Arthritis

Trial details

Who runs it

Cardiff University

Trial code

EU 2024-518011-19-01

Record updated

2026. július 14.

Original description

Proportion of patients who achieve disease remission at week 24 will be the primary endpoint. Remission will be defined by: • Clinical Disease Activity Index (CDAI) 2.8 or < 2.8 in RA • DAPSA <4 in PsARead full original descriptionShow less

DECISION ON OPTIMAL COMBINATORIAL THERAPIES IN IMMUNE-MEDIATED INFLAMMATORY DISEASES (IMIDS) USING SYSTEMS APPROACHES

Proportion of patients who achieve disease remission at week 24 will be the primary endpoint. Remission will be defined by: • Clinical Disease Activity Index (CDAI) 2.8 or < 2.8 in RA • DAPSA <4 in PsA

Inclusion: Adult patients (≥18 years old), no upper age limit; 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); Current treatment with any approved Tumour Necrosis Factor inhibitors (TNFis) for at least 6 weeks; Active arthritis as defined by: • DAS28 score > 3.2 for Rheumatoid Arthritis • Disease Activity in Psoriatic Arthritis (DAPSA) >14 for Psoriatic Arthritis; Signed informed consent.

Exclusion: Known HIV or hepatitis B/C infection (satisfactory hepatitis B screening test must have been done previously); 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; Receipt of live vaccine <4 weeks prior to first infusion; Major surgery in 3 months prior to first infusion; Presence of a transplanted organ (with the exception of a corneal transplant >3 months prior to screening); Known recent substance abuse (drug or alcohol); Previous treatment with any IL-6is (tocilizumab or sarilumab); Intra articular or parenteral corticosteroids ≤ 4 weeks prior Visit 2; Oral prednisolone more than 10mg per day or equivalent ≤ 4 weeks prior to Visit 2; Contraindications to any of the biologic treatment e.g. active infection; Malignancy (other than basal cell carcinoma) within the last 10 years; New York Heart Association (NYHA) grade 3 or 4 congestive cardiac failure; Demyelinating disease; History of or current primary inflammatory joint disease or primary autoimmune disease other than RA; Active infection; 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; Sepsis of a prosthetic joint within 12 months or indefinitely if the joint remains in situ; Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period; Patients currently recruited to other clinical trial(s) involving an Investigational Medicinal Pproduct (IMP), except any observational follow-up periods not involving an IMP); Women who are pregnant or breast-feeding; 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; Septic arthritis within a native joint within the last 12 months.

EU CTIS 2024-518011-19-01