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

Not Applicable

• Conditions: Rheumatoid Arthritis

• Registration Number: JPRN-jRCT1080224168
• Lead Sponsor: DAIICHISANKYO Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-03
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: other
• Sex: All
• Target Recruitment: 2000

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

[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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>Hypocalcemia(Serum calcium level <8.50 mg/dL)<br>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 Outcome Measures

Name	Time	Method
safety<br>Severe hypocalcemia(Serum calcium level <7.00 mg/dL)<br>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.