The aim of this study is to describe pharmacokinetic parameters of the following golimumab regimens: 50 mg every month, 100 mg every one-and-a-half month and 100 mg every two months, in patients with a rheumatic disease.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint is to describe serum peak levels, trough levels and AUC of
golimumab 50 mg every month, 100 mg every one-and-a-half month and 100 mg every
two months.
Secondary outcome
Secondary endpoints include efficacy, adverse events, presence of anti-drug
antibodies and patient preference.
Background summary
Golimumab is a TNF-inhibitor, proven effective for rheumatoid arthritis,
psoriatic arthritis and axial spondyloarthritis, in a dose of 50 mg every
month. For patients with a body weight over 100 kilograms, one-hundred
milligram golimumab injections are also authorized when therapy with 50 mg is
considered ineffective. With the 100 mg injections available and considered
safe, golimumab therapy using 100mg injections with a prolonged dose interval
can be constructed, to offer patients an equally effective treatment with fewer
injections. More knowledge on the pharmacokinetic parameters of golimumab in
patients is needed to construct a certain dosing regimen. Assuming that a
doubled dose (100 mg) will lead to at least one additional half-life before the
same trough level is reached, compared to a single dose, 100 mg every
one-and-a-half month would be equal in trough levels to 50 mg every month,
given a half-life of approximately thirteen days. On the other hand, for the
area-under-the-curve (AUC), the dose interval should be doubled, leading to a
dosing schedule of 100 mg every two months.
Study objective
The aim of this study is to describe pharmacokinetic parameters of the
following golimumab regimens: 50 mg every month, 100 mg every one-and-a-half
month and 100 mg every two months, in patients with a rheumatic disease.
Study design
Open-label within-subject controlled study design.
Intervention
Patients will switch from golimumab 50 mg every month to golimumab 100 mg every
one-and-a-half month and 100 mg every two months consecutively, both for two
cycles.
Study burden and risks
The risks associated with this study are limited, since patients participating
in this study already use golimumab. In the literature, golimumab 100mg every
month did show more lymphomas compared to 50 mg. However, this seems caused by
confounding by indication due to active rheumatoid arthritis being associated
with higher lymphoma risk, and this is also corroborated by systemic reviews
showing that use of TNF-inhibitors does not result in increase in lymphoma
risk. Also, since in this study golimumab 100mg is dosed every one-and-a-half
month and every two months, we expect lower risks than 100 mg every month.
Possible risks include adverse events to the 100mg golimumab injection, which
could be injection site reactions or systemic adverse events. The burden of
patients participating in this study is mainly time investment, including
twelve study visits for a total of twelve blood samples (four serum samples for
every regime to construct peak level, trough level and AUC) and three disease
activity measurements, and any regular or unplanned visits with the
rheumatologist. A possible benefit for patients is the opportunity to use
golimumab less frequently, and therefore lowering the burden of injection
therapy and possibly the chance of injection site reactions. The study also
includes societal benefits as in many healthcare systems, the 50 and 100 mg
golimumab formulation are flat priced.
Hengstdal 3
Ubbergen 6574NA
NL
Hengstdal 3
Ubbergen 6574NA
NL
Listed location countries
Age
Inclusion criteria
• Rheumatoid arthritis, psoriatic arthritis or axial spondyloarthritis by
fulfilling one of the following:
o Rheumatoid arthritis: either 2010 ACR RA and/or 1987 RA criteria and/or
clinical diagnosis of the treating rheumatologist;
o Psoriatic arthritis: Classification Criteria for Psoriatic Arthritis (CASPAR)
and/or diagnosed with peripheral SpA of the psoriatic arthritis subtype by a
rheumatologist;
o Axial spondyloarthritis: Assessment of SpondyloArthritis international
Society (ASAS) classification criteria and/or clinical diagnosis of the
treating rheuma-tologist;
• Patients using golimumab in the standard dose of 50mg every month for at
least three months with a good clinical response, defined as DAS28-CRP <= 2.6
for RA, or PASDAS <= 3.2 (PsA) or ASDAS <= 2.1;
• Patient informed consent, >=16 years old and mentally competent;
• Ability to measure the outcome of the study in this patient (e.g. patient
availability; willing and being able to undergo repeated serum samples);
• Ability to read and communicate well in Dutch.
Exclusion criteria
Pregnancy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-004101-27-NL |
| CCMO | NL71931.091.19 |