INDIGO: Comparing pharmacokinetic parameters of golimumab 50 mg and golimumab 100 mg with a prolonged dose interval in patients with a rheumatic disease, a within-subject controlled study*

Phase 4

• Conditions: arthritis; rheumatic diseases; rheumatoid arthritis; 10003816; 10023213

• Registration Number: NL-OMON48335
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 35

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint is to describe serum peak levels, trough levels and AUC of<br /><br>golimumab 50 mg every month, 100 mg every one-and-a-half month and 100 mg every<br /><br>two months. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include efficacy, adverse events, presence of anti-drug<br /><br>antibodies and patient preference.</p><br>