Research into injecting golimumab less frequently by using increased doses

Golimumab is a TNF receptor antagonist, proven effective in the treatment of rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, in a dose of 50 mg every month. Apart from the 50 milligram injections, 100 milligram injections are also on the market, registered for patients weighing > 100 kg for whom treatment with 50 milligram is not considered effective. However, 100 milligram injections were also tested on normal-weight patients in the registration studies, proven effective and safe, even on long-term. With the 100 milligram injections being available, a new dosing schedule can be created, in which 100 milligram is given with a prolonged dose interval, which would lead to a lower frequency of injections for patients with the same efficacy.
But, there is not much known on the pharmacokinetics of golimumab 100 mg with a prolonged dose interval in patients with a rheumatic disease, so that such a dosing schedule can not yet be created. Therefore, the aim of this explorative study is to determine pharmacokinetic parameters (peak level, trough level, AUC) of the following golimumab regimens: 50 mg every month (control), 100 mg every 1,5 months (expected similar trough levels to 50 mg every month with a drug half-life of 14 days) and 100 mg every 2 months (expected similar AUC to 50 mg every month).

Golimumab 100 mg every 1,5 month has similar trough levels to golimumab 50 mg every month; golimumab 100 mg every 2 months has a similar AUC to golimumab 50 mg every month.

Disease activity measurements: baseline, 4 months, 8 months
Golimumab serum level measurements: trough - peak - in between - trough for every regimen in the last cycle

1) Golimumab 50 mg every month (1 cycle)
2) Golimumab 100 mg every 1,5 month (2 cycles)
3) Golimumab 100 mg every 2 months (2 cycles)