Research into injecting golimumab less frequently by using increased doses

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’ - INDIGO

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004101-27-NL

Enrollment

Registered

2019-12-12

Start date

2020-01-15

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis MedDRA version: 21.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Clas

Interventions

Trade Name: Simponi Pharmaceutical Form: Solution for injection INN or Proposed INN: GOLIMUMAB CAS Number: 476181-74-5 Concentration uni

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Rheumatoid arthritis, psoriatic arthritis or axial spondyloarthritis by fulfilling one of the following: o Rheumatoid arthritis: either 2010 ACR RA13 and/or 1987 RA14 criteria and/or clinical diagnosis of the treating rheumatologist; o Psoriatic arthritis: Classification Criteria for Psoriatic Arthritis (CASPAR)15 and/or diagnosed with peripheral SpA of the psoriatic arthritis subtype by a rheumatologist; o Axial spondyloarthritis: Assessment of SpondyloArthritis international Society (ASAS) classification criteria16 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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: To describe the peak levels, trough levels and AUC of the following golimumab regimens: 50 mg every month, and 100 mg every one-and-a-half month and 100 mg every two months, in patients with a rheumatic disease. ; Secondary Objective: • To evaluate the efficacy of the two 100mg regimens by changes in disease activity (DAS28-CRP, ASDAS, PASDAS) compared to 50mg every month; • To identify the proportion of patients with undetectable golimumab levels and / or antibodies to golimumab; • To assess the incidence of AEs, with special interest to injection site reactions; • To establish which regimen is preferred by patients: 50 mg every month or 100 mg every one-and-a-half month or two months. ;Primary end point(s): The main aim of the study is to describe peak levels, trough levels and area-under-the-curve of golimumab 50 mg every month, 100 mg every one-and-a-half month and 100 mg every two months. To measure these parameters, blood samples will be drawn at twelve points during the study. Samples will then be analysed using a validated bioanalytical assay for golimumab in serum at the bioanalytical laboratory of Sanquin. ;Timepoint(s) of evaluation of this end point: Twelve points in time over eight months (4 in the 1st month, 2 in the 3rd month, 2 in the 4th month, 1 in the 6th month, 1 in the 7th month en 2 in the eighth month)	—

Measure

Time frame

Main Objective: To describe the peak levels, trough levels and AUC of the following golimumab regimens: 50 mg every month, and 100 mg every one-and-a-half month and 100 mg every two months, in patients with a rheumatic disease. ; Secondary Objective: • To evaluate the efficacy of the two 100mg regimens by changes in disease activity (DAS28-CRP, ASDAS, PASDAS) compared to 50mg every month; • To identify the proportion of patients with undetectable golimumab levels and / or antibodies to golimumab; • To assess the incidence of AEs, with special interest to injection site reactions; • To establish which regimen is preferred by patients: 50 mg every month or 100 mg every one-and-a-half month or two months. ;Primary end point(s): The main aim of the study is to describe peak levels, trough levels and area-under-the-curve of golimumab 50 mg every month, 100 mg every one-and-a-half month and 100 mg every two months. To measure these parameters, blood samples will be drawn at twelve points during the study. Samples will then be analysed using a validated bioanalytical assay for golimumab in serum at the bioanalytical laboratory of Sanquin. ;Timepoint(s) of evaluation of this end point: Twelve points in time over eight months (4 in the 1st month, 2 in the 3rd month, 2 in the 4th month, 1 in the 6th month, 1 in the 7th month en 2 in the eighth month)

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Adverse events and efficacy at the 4th, 8th and 12th visit Regime preference at the 12th visit Antibody development can be checked for every blood sample of golimumab, when concentration is < 0.1 mg/L ; Secondary end point(s): Efficacy Disease activity will be measured at maximum one week before or after every second trough level sampling day, to be able to compare the three regimes in efficacy. Disease activity will be measured using the DAS28-CRP for RA, using the PASDAS for PsA and using the ASDAS for axSpA. Therefore, the following outcomes will be collected: - Acute phase reactants: CRP (for RA, PsA and axSpA) and ESR (axSpA); - Physician Global Assessment of disease activity (PsA); - Patient Global Assessment of disease activity (RA, PsA, axSpA); - BASDAI/ASDAS-questionnaire (axSpA); - SF-12 questionnaire (PsA); - Physical examination: tender joint count (RA, PsA), swollen joint count (RA, PsA), dactylitis and enthesitis (using the Leeds Enthesitis Index (PsA)). The acute phase reactants analysis will be performed in the laboratory of the Canisius Wilhelmina Hospital, located in the Sint Maartenskliniek. Antibodies Presence of anti-drug antibodies against golimumab will be measured in the proportion of patients with undetectable golimumab levels. This means that in patients with golimumab levels < 0.1 mg/L17 anti-drug antibodies will be measured in serum. Samples will then be analysed using a validated ADA radio-immune assay at the bioanalytical laboratory of Sanquin. Adverse events The occurrence of adverse events during the study period will be registered using the Common Toxicity Criteria for Adverse Events (CTCAE). [BRON] For injection site reactions, a list wi	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Adverse events and efficacy at the 4th, 8th and 12th visit Regime preference at the 12th visit Antibody development can be checked for every blood sample of golimumab, when concentration is < 0.1 mg/L ; Secondary end point(s): Efficacy Disease activity will be measured at maximum one week before or after every second trough level sampling day, to be able to compare the three regimes in efficacy. Disease activity will be measured using the DAS28-CRP for RA, using the PASDAS for PsA and using the ASDAS for axSpA. Therefore, the following outcomes will be collected: - Acute phase reactants: CRP (for RA, PsA and axSpA) and ESR (axSpA); - Physician Global Assessment of disease activity (PsA); - Patient Global Assessment of disease activity (RA, PsA, axSpA); - BASDAI/ASDAS-questionnaire (axSpA); - SF-12 questionnaire (PsA); - Physical examination: tender joint count (RA, PsA), swollen joint count (RA, PsA), dactylitis and enthesitis (using the Leeds Enthesitis Index (PsA)). The acute phase reactants analysis will be performed in the laboratory of the Canisius Wilhelmina Hospital, located in the Sint Maartenskliniek. Antibodies Presence of anti-drug antibodies against golimumab will be measured in the proportion of patients with undetectable golimumab levels. This means that in patients with golimumab levels < 0.1 mg/L17 anti-drug antibodies will be measured in serum. Samples will then be analysed using a validated ADA radio-immune assay at the bioanalytical laboratory of Sanquin. Adverse events The occurrence of adverse events during the study period will be registered using the Common Toxicity Criteria for Adverse Events (CTCAE). [BRON] For injection site reactions, a list wi

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Countries

Netherlands

Contacts

Public ContactJunior Investigator

Sint Maartenskliniek

C.vanderTogt@maartenskliniek.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026