Development and validation of the risk prediction model for serious infections in rheumatoid arthritis (RA) patients treated with Tocilizumab using a medical information database

Development and validation of the risk prediction model for serious infections in rheumatoid arthritis (RA) patients treated with Tocilizumab using a medical information database - Development and validation of the risk prediction model for serious infections in rheumatoid arthritis (RA) patients treated with Tocilizumab using a medical information database

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000050079

Enrollment

6000

Registered

2023-01-19

Start date

2023-03-20

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The inclusion criteria are all of the following: ?Confirmed diagnosis of RA (ICD -10 Diagnosis Code M05/M06) can be identified during the baseline period (excluding diagnoses with the "Suspect" flag). ?Initial tocilizumab prescriptions are available during the patient selection period. ?Prescription of antirheumatic drugs during the baseline period.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study: ?Prescription of tocilizumab cannot be identified after index date. ?Patients with a history of treatment for malignant tumors during the baseline period (6 months immediately before the index date) and at the reference date (defined as either of the following) History of prescription of "injury/disease name of malignant tumor" and" antineoplastic drug" (However, methotrexate, rituximab, and tacrolimus are excluded from the list of "antineoplastic agents") History of prescription of "radiotherapy" ?Patients who don't have a 4-month lookback period ?Patients with a confirmed disease name other than RA for which tocilizumab is indicated during the baseline period or index date Indications listed for intravenous infusion: juvenile idiopathic arthritis, adult Still's disease, Castleman's disease, pneumonia caused by SARS-CoV-2, cytokine release syndrome Indications listed for subcutaneous injection: Takayasu's arteritis, giant cell arteritis

Design outcomes

Primary

Measure	Time frame
The calibration capability of the model is visually represented by a calibration plot divided into 10 aliquots. Area under the curve (AUC) is used as a measure of discrimination. Sensitivity, specificity, and positive and negative predictive values at each 5% risk threshold are used as measures of accuracy.	—

Countries

Japan

Contacts

Public ContactShinichi Matsuda

Chugai Pharmaceutical Co., Ltd. Risk Communication Dept.

matsudasni@chugai-pharm.co.jp03-3281-6611

Outcome results