TREATMENT ARM | TREATMENT DESCRIPTION | |
---|---|---|
Rituximab | Single dose of 1 g as an intravenous infusion to be administered at days 0 (week 0) and 15 (week 2; +5 days). | |
In line with standard practice, a participant who loses an initial 6 month (week 24) response as per NICE guidance may receive a further cycle of rituximab after a minimum of 6 months following the first dose. The second cycle of rituximab will be given at a dose of 1 g x 2 intravenous infusions will be administered at a 2-week interval (+5 days). | ||
Abatacept | Abatacept solution for subcutaneous injection: 125 mg/syringe (125 mg/mL). Abatacept will be given at a dose of 125 mg by subcutaneous injection at week 0 and once weekly thereafter for a minimum of 24 weeks. | |
Supplied by Bristol-Myers Squibb free of charge. Trial supplies to be ordered by individual sites which will be responsible for ring-fencing abatacept upon receipt. | ||
Alternative mechanism anti-TNF | Etanercept | Single dose of 50 mg etanercept by subcutaneous injection weekly for a minimum of 24 weeks (unless not tolerated). |
Adalimumab | Single dose of 40 mg adalimumab by subcutaneous injection every 2 weeks for a minimum of 24 weeks (unless not tolerated). | |
Infliximab | Infliximab will be given at a dose of 3 mg/kg per intravenous infusion, administered on a day-case unit or equivalent. The intravenous infusions will be administered at week 0, 2 (+/- 2 days), 6 (+/- 2 days) and then 8-weekly thereafter (+/- 7 days) for a minimum of 24 weeks. | |
Certolizumab Pegol | Single dose of 400 mg by subcutaneous injection at weeks 0, 2, 4 and then at a dose of 200 mg every 2 weeks thereafter for a minimum of 24 weeks. | |
Certolizumab pegol will be available free of charge for the first 12 weeks of protocol treatment if supplied by UCB Pharma through their RA Patient Access Scheme. |