Investigation of the Risk of Hypocalcemia in Patients With Rheumatoid Arthritis Who Were Treated for the First Time With Pralia Subcutaneous Injection 60 mg Syringe

Investigation of the Risk of Hypocalcemia in Patients With Rheumatoid Arthritis Who Were Treated for the First Time With Pralia Subcutaneous Injection 60 mg Syringe -Medical Information Database Network-based Cohort Study-

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080224168

Enrollment

2000

Registered

2018-12-03

Start date

2018-12-03

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

investigational material(s) Generic name etc : PRALIA 60mg Subcutaneous Injection Syringe(denosumab) INN of investigational material : denosumab Therapeutic category code : 399 Agents affecting metabo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: [The study population] Patients who meet all of the following will be included in the study: -Disease-modifying anti-rheumatic drugs (DMARDs) have been administered in the data period. -Diagnosed rheumatoid arthritis is present between 30 days before DMARDs administration and day of DMARDs administration in the data period. [The patient cohort treated for the first time with Pralia] Patients who meet the following will be allocated: -Pralia has been administered in or after July 3, 2017. [The patient cohort not treated with Pralia] Patients who meet the following will be allocated: -Pralia has not been administered in or after July 3, 2017.

Exclusion criteria

Exclusion criteria: [The study population] Patients who meet the following will be excluded from the study: -Pralia was administered in or before June 2, 2017 [The patient cohort treated for the first time with Pralia] Patients who meet any of the following will be excluded: -The period from the start day of the observation period to the start day of follow-up is less than 210 days. -Ranmark Subcutaneous Injection 120 mg has been administered during the look-back period (the period from 210 days before the start day of follow-up to on the day before the start date of follow-up) or follow-up period. -During Look back period, there is no DMARDs administration with diagnosed rheumatoid arthritis between 30 days before DMARDs administration and day of DMARDs administration in the data period. -No medical record is present since the start day of follow-up. [The patient cohort not treated with Pralia] Patients who meet any of the following will be excluded: -The period from the start day of the observation period to the start day of follow-up is less than 210 days. -Ranmark Subcutaneous Injection 120 mg has been administered during the look-back period or follow-up period. -During Look back period, there is no DMARDs administration with diagnosed rheumatoid arthritis between 30 days before DMARDs administration and day of DMARDs administration in the data period. -No medical record is present since the start day of follow-up.

Design outcomes

Primary

Measure	Time frame
safety Hypocalcemia(Serum calcium level <8.50 mg/dL) The incidence of hypocalcemia will be calculated for each patient cohort. The risk ratio in the patient cohort treated for the first time with Pralia to the patient cohort not treated with Pralia and its 95% confidence interval will be calculated.	—

Secondary

Measure	Time frame
safety Severe hypocalcemia(Serum calcium level <7.00 mg/dL) The incidence of hypocalcemia will be calculated for each patient cohort. The risk ratio in the patient cohort treated for the first time with Pralia to the patient cohort not treated with Pralia and its 95% confidence interval will be calculated.	—

Countries

Japan

Outcome results

None listed

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