Rheumatoid arthritis Musculoskeletal Diseases
Conditions
Interventions
Intervention Arm (Abatacept and Methotrexate):
Abatacept: 125 mg solution for injection, subcutaneous, weekly.
Methotrexate: Dose according to local guidelines.
Control Arm (Placebo and Methotrexate)
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Adults (female and male) aged 18 years or over. 2. Willing and capable of giving informed consent. 3. 2010 ACR / EULAR classification criteria for a diagnosis of Rheumatoid Arthritis. * 4. Symptom duration of 3.2) 7. No prior DMARD therapies (conventional, targeted or biologic DMARDs) 8. Patient is judged by the supervising clinician to be a suitable candidate based upon medical history, physical examination, vital signs, and routine laboratory tests. 9. Willing and able to comply with scheduled visits, laboratory tests, and other study procedures. * The ACR/EULAR classification for a diagnosis of RA could have been at any time in the patient’s disease history; the score does not need to be 6 or more at screening.
Exclusion criteria
Exclusion criteria: 1. Patients unable to tolerate synovial biopsy or in whom this is contraindicated including patients on anti-coagulants (e.g. warfarin). Patients on short-acting direct oral anticoagulant agents can be considered when anti-coagulant can be temporarily stopped, in line with local guidelines for procedures with a low risk of bleeding, taking into account the individual thromboembolic risk. Oral anti-platelet agents are permitted. 2. Patients in whom there is no suitable joint for biopsy. 3. Hypersensitivity to the active substance or to any of the excipients of abatacept or methotrexate, or any other contraindications to the study medications, as per the current SmPC. 4. History of or current primary inflammatory joint disease or primary rheumatological autoimmune disease other than RA (if secondary to RA, then the patient is still eligible). 5. Prior exposure to any biologic/targeted DMARDs for RA 6. Treatment with any investigational agent = 8 weeks prior to baseline or 3 months prior to screening). 18. Known recent substance abuse (drug or alcohol). 19. Patients currently recruited to other clinical trials or taking part in a CTIMP study in the previous 4 months. 20. 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. This should include assessment of risk factors for known clinically important risks associated with a study drug. 21. Patients with severe hepatic impairment (Child Pugh C classification). 22. Patients that are primary or secondary immunodeficiency (history of or currently active). 23. Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period. 24. Women who are pregnant or breast-feeding. 25. Women of child-bearing potential or males whose partners are women of child-bearing potential, unwilling to use an effective method of contraception (recommend double contraception) throughout the trial and beyond the end of trial treatment for the duration as defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Disease Activity Index (CDAI) at baseline and 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients with DAS28(ESR)<3.2 (LDA) at 16 weeks 2. Percentage of patients deemed responders using American College of Rheumatology 50 (ACR50) measure at 16 weeks 3. Percentage of patients with CDAI remission at 16 weeks 4. HAQ-DI at baseline and 16 weeks 5. SF-36 at baseline and 16 weeks | — |
Countries
Belgium, England, Italy, Netherlands, Portugal, Spain, United Kingdom
Outcome results
None listed