Usefullness of infliximab as a second tumor necrosis factor inhibitor in patients with rheumatoid arthritis with inadequate response to tumor necrosis factor inhibitor

Usefullness of infliximab as a second tumor necrosis factor inhibitor in patients with rheumatoid arthritis with inadequate response to tumor necrosis factor inhibitor - IFX-2nd

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023006

Enrollment

Registered

2016-07-15

Start date

2016-07-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

rheumatoid arthritis

Interventions

administrated with 3mg/kg of IFX administrated with 10mg/kg of IFX

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Out-patients who is planned to receive IFX with active moderate-to-severe RA with inadequate response to adalimumab, etanercept, golimumab or certolizumab pegol 2) The patients who administrated with methotrexate 3) Patients must have taken stable dose of NSAID, glucocorticoid, or conventional synthetic disease modifying anti rheumatic drugs 4) Aged 20 years or older and less than 85 years old 5) The patients who provided their informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1) The patients with inadequate response to IFX after 6-weekloading administration 2) The patients with arthritic condition other than Ra 3) The patients who is planned to undergo surgery 4) Patients with allergy to IFX 5) Patients who is pregnant or lactate 6)patients who have received IFX administration 7) Those who are not approved to be eligible to this study by corresponding researcher or co-researchers

Design outcomes

Primary

Measure	Time frame
Evaluation of disease activity score 28-CRP (DAS28-CRP) at 30 weeks	—

Secondary

Measure	Time frame
1) Evaluation of structural damage by modified total Sharp score at 54 weeks 2) Evaluation of synovitis by ultrasound at 54 weeks 3) Evaluation of blood test at 54 weeks 4) Evaluation of modified Health Assessment Questionnaire at 54 weeks 5) Adverse reaction at 54 weeks 6) Evaluation of DAS28-CRP at 30 weeks	—

Countries

Japan

Contacts

Public ContactKentaro Inui

Osaka City University Graduate School of Medicine Orthopaedic Surgery

inuken@med.osaka-cu.ac.jp06-6645-3851

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026