Research into injecting golimumab less frequently by using increased doses

Recruiting

Conditions: Rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (axSpA)

Registration Number: NL-OMON21487

Lead Sponsor: Sint Maartenskliniek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 35

Inclusion Criteria

1) rheumatoid arthritis (according to 2010 ACR RA and/or 1987 RA criteria and/or clinical diagnosis confirmed by a rheumatologist)
or psoriatic arthritis (according to CASPAR criteria and/or clinical diagnosis of peripheral SpA of the psoriatic arthritis subtype confirmed by a rheumatologist)
or axial spondyloarthritis (according to ASAS criteria and/or clinical diagnosis confirmed by a rheumatologist)
2) patients using golimumab in the standard dose of 50 mg every month for at least three months with a good clinical response, defined as DAS28-CRP =< 2.6 or PASDAS =< 3.2 or ASDAS =< 2.1
3) Informed consent, >= 16 years old and mentally competent
4) Ability to measure the outcome of the study in this patient (e.g. patient availability, willing and being able to undergo repeated serum samples)
5) Ability to read and communicate well in Dutch

Exclusion Criteria

1) Pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Description of peak levels, trough levels and area-under-the-curve (AUC) 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.

Secondary Outcome Measures

Name	Time	Method
1) Efficacy of the two intervention regimens by changes in disease activity (DAS28-CRP, ASDAS or PASDAS) compared to 50 mg every month;<br>2) Proportion of patients with undetectable golimumab levels and/or antibodies to golimumab;<br>3) Incidence of AEs, with special interest to injection site reactions;<br>4) Preference of participants: 50 mg every month or 100 mg with a prolonged interval