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Table 2 The three treatment arms of the Switch trial

From: The 'Switch’ study protocol: a randomised-controlled trial of switching to an alternative tumour-necrosis factor (TNF)-inhibitor drug or abatacept or rituximab in patients with rheumatoid arthritis who have failed an initial TNF-inhibitor drug

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.

  1. Golimumab Single dose of 50 mg by subcutaneous injection every 2 weeks for a minimum of 24 weeks.