Rheumatoid arthritis (RA) and psoriatic arthritis (PsA) Musculoskeletal Diseases
Conditions
Interventions
The DocTIS trial is a single-arm, adaptive basket trial design. In this study, the researchers will recruit patients with rheumatoid or psoriatic arthritis who are receiving any one of the following i
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients (=18 years old) 2. Patient must fulfil either European Alliance of Associations for Rheumatology (EULAR)/Albumin: Creatinine Ratio (ACR) classification criteria for the diagnosis of Rheumatoid Arthritis (RA), or Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) criteria for Psoriatic Arthritis (PsA) 3. Current treatment with any approved Tumour Necrosis Factor inhibitors (TNFis) 4. Active arthritis as defined by: 4.1. DAS28 score >3.2 for Rheumatoid Arthritis (RA) 4.2. Disease Activity in Psoriatic Arthritis (DAPSA) >14 for Psoriatic Arthritis PsA 5. Signed informed consent
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 11/09/2025: 1. Contraindications to any of the biologic treatment e.g. active infection 2. Previous treatment with any IL-6is (tocilizumab or sarilumab) 3. Women who are pregnant or breast-feeding 4. Women of child-bearing potential, or males whose partners are women of childbearing potential, unwilling to use effective contraception during the study and for at least 3 months after stopping study treatment 5. History of or current primary inflammatory joint disease or primary autoimmune disease other than RA 6. Intra articular or parenteral corticosteroids = 4 weeks prior Visit 2 7. Oral prednisolone more than 10mg per day or equivalent = 4 weeks prior to Visit 2 8. Active infection 9. Septic arthritis within a native joint within the last 12 months 10. Sepsis of a prosthetic joint within 12 months or indefinitely if the joint remains in situ 11. Known HIV or hepatitis B/C infection (satisfactory hepatitis B screening test must have been done previously) 12. Malignancy (other than basal cell carcinoma) within the last 10 years 13. New York Heart Association (NYHA) grade 3 or 4 congestive cardiac failure 14. Demyelinating disease 15. 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 16. Receipt of live vaccine 3 months prior to screening) 19. Known recent substance abuse (drug or alcohol) 20. Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period 21. Patients currently recruited to other clinical trial(s) involving an Investigational Medicinal Product ([IMP)], except any observational follow-up periods not involving an IMP) 22. 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 Previous key exclusion criteria: 1. Contraindications to any of the biologic treatment e.g. active infection 2. Previous treatment with any IL-6is (tocilizumab or sarilumab) 3. Women who are pregnant or breast-feeding 4. Women of child-bearing potential, or males whose partners are women of childbearing potential, unwilling to use effective contraception during the study and for at least 3 months after stopping study treatment 5. History of or current primary inflammatory joint disease or primary autoimmune disease other than RA 6. Intra articular or parenteral corticosteroids = 4 weeks prior Visit 2 7. Oral prednisolone more than 10mg per day or equivalent = 4 weeks prior to Visit 2 8. Active infection 9. Septic arthritis within a native joint within the last 12 months 10. Sepsis of a prosthetic joint within 12 months or indefinitely if the joint remains in situ 11. Known HIV or hepatitis B/C infection (hepatitis B screening test must be performed at or in the preceding 3 months of screening visit) 12. Malignancy (other than basal cell carcinoma) within the last 10 years 13. New York Heart Association (NYHA) grade 3 or 4 congestive cardiac failure 14. Demyelinating disease 15. Any other contra-indi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who achieve disease remission at week 24. A total of 36 patients are required to assess the primary endpoint, with an expectation of up to 10% drop-out, resulting in a total patient population of 40. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety will include the number of serious adverse events (SAEs), adverse events (AEs), adverse events of special interest (AESIs) and withdrawals due to SAEs, AEs or AESIs. Severe infection requiring hospitalisation will be included as AESI. 2. Disease-specific activity scores and percentage improvement in disease activity measured using: 2.1. RA: American College of Rheumatology (ACR) and European Alliance of Associations for Rheumatology (EULAR) response criteria, change in Clinical Disease Activity Index (CDAI) and Disease Activity Score with Erythrocyte Sedimentation Rate (DASESR) scores, physical disability by modified Health Assessment Questionnaire (mHAQ) 2.2. PsA: Disease Activity in Psoriatic Arthritis (DAPSA), American College of Rheumatology (ACR) response, Psoriatic Arthritis Response Criteria (PsARC) response, physical disability by modified Health Assessment Questionnaire (mHAQ) Safety will be measured and evaluated throughout the trial and reported cumulatively in both diseases separately. | — |
Countries
United Kingdom
Contacts
Public ContactIan Thomas
Outcome results
None listed