Clinical trial NCT05572567: Study to Evaluate Safety and Effects of Tofacitinib and Biologic Disease Modifying Antirheumatic Drugs in People Treated for Rheumatoid Arthritis
Official title: An Observational Study Within the CorEvitas Registry to Evaluate Safety and Effectiveness of Tofacitinib and Biologic Disease Modifying Antirheumatic Drugs (bDMARDs) in Japan Among Patients Treated for Moderately to Severely Active Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-10-07
Enrollment: 1972
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in an existing registry database

Brief summary: This is a secondary structured database observational study conducted in Rheumatoid Arthritis (RA) patients treated with biologic and nonbiologic DMARDs, including tofacitinib, collected as part of the CorEvitas Japan RA Registry.

The data as of September 2022 will be used for this study. The study will include data from March 2016 to the latest data cut available in 2022 for both effectiveness and safety outcomes.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Rheumatoid Arthritis (RA) according to the 1987 American College of Rheumatology (ACR) or the ACR/European Lead Against Rheumatism (EULAR) 2010 RA Classification Criteria;
* At least 18 years of age or older;
* Was / Must be prescribed or switching to the following eligible medication for the first time ever at the enrollment visit:
* csDMARD: methotrexate (closed in February 2018);
* Anti-TNF bDMARD: adalimumab (originator or biosimilar), certolizumab pegol, etanercept (originator or biosimilar), golimumab, infliximab (originator or biosimilar), or any other anti-TNF biosimilar approved during the study;
* Non-TNF bDMARD: abatacept, tocilizumab, sarilumab (closed in June 2020);
* JAK inhibitor: tofacitinib, baricitinib, peficitinib, filgotinib, upadacitinib.

Exclusion Criteria:

* Data that are prior to March 2016 and after June 2022

Primary outcomes:
measure: Mean Incidence Rate of Total Cardiovascular Disease (CVD) Events
timeFrame: Retrospective data collection from index visit date up to follow-up or latest data cut on 30 June 2022 (Approximately up to 75 months)
measure: Mean Incidence Rate of Serious Infections Events
timeFrame: Retrospective data collection from index visit date up to follow-up or latest data cut on 30 June 2022 (Approximately up to 75 months)
measure: Mean Incidence Rate of Total Herpes Zoster Events
timeFrame: Retrospective data collection from index visit date up to follow-up or latest data cut on 30 June 2022 (Approximately up to 75 months)
measure: Mean Incidence Rate of Total Malignancy Excluding Non-Melanoma Skin Cancer (NMSC)
timeFrame: Retrospective data collection from index visit date up to follow-up or latest data cut on 30 June 2022 (Approximately up to 75 months)
measure: Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at 6 Months
timeFrame: Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)
measure: Mean Change From Baseline in Japanese Health Assessment Questionnaire (J-HAQ) at 6 Months
timeFrame: Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)
measure: Mean Change From Baseline in Participant's Pain at 6 Months
timeFrame: Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)
measure: Mean Change From Baseline in Participant's Fatigue at 6 Months
timeFrame: Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)
measure: Mean Change From Baseline in Participant's Global Assessment at 6 Months
timeFrame: Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)
measure: Mean Change From Baseline in Morning Stiffness at 6 Months
timeFrame: Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)
measure: Change in Percentage of Participants Reporting Moderate/Severe/Extreme Difficulty Levels for EQ-5D-5L From Baseline at Month 6
timeFrame: Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)
measure: Percentage of Participants Who Achieved Minimally Clinically Important Difference (MCID) Improvement at 6 Months
timeFrame: Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)
measure: Percentage of Participants Who Achieved Modified American College of Rheumatology (mACR) 20 Response Score at 6 Months
timeFrame: Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)
measure: Percentage of Participants Who Achieved mACR 50 Response Score at 6 Months
timeFrame: Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)
measure: Percentage of Participants Who Achieved mACR 70 Response Score at 6 Months
timeFrame: Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: