A Study to Determine the Risk of Cancer in Rheumatoid Arthritis (RA) Patients Who Use Abatacept and Other Biologic Agents

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Other: Non-Interventional

• Registration Number: NCT03670667
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

An observational study to determine the risk of cancer associated with the use of abatacept and other biologic agents among rheumatoid arthritis patients

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2017-02-22
• Study First Submitted: 2018-09-07
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-13
• Primary Completion: 2019-03-29
• Study Completion: 2019-03-29
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1132

Inclusion Criteria

• RA patients will be identified using algorithms that require ≥ 1 rheumatologist (physician specialty code: 66) diagnosis codes for RA (at least one of the following ICD9 diagnosis codes: 714.0, 714.2, 714.81) at any time before the first claim for a specific drug (Index date) during the study period and ≥1 physician (affiliated with physician evaluation & management codes, listed in the appendix 2) diagnosis codes within 12 months before the first claim for a specific drug use. The index date is defined as the date of the first claim for a specific drug use, and the baseline period is defined as 12 months prior to specific drug use
• Naive users of biologics, including abatacept, anti-TNFs (i.e. etanercept, adalimumab, certolizumab, golimumab, infliximab), rituximab, and tocilizumab, will be defined specific to each drug as no claim for that therapy in any time prior to the index date
• Eligible subjects, including cancer patients in SEER and non-cancer beneficiaries from 5% sample, must have been continuously enrolled in Medicare Parts A, B and D and not C at their index date and during baseline

Read More

Exclusion Criteria

• Patients diagnosed with any cancer (ignoring non-melanoma skin cancer, which is not captured within SEER) before the use of biologics under study. Cancer cases will be identified based on the records in SEER
• Patients who were younger than 18 years on the index date
• Patients with claims for other types of auto-immune diseases (e.g. psoriatic arthritis, systemic lupus erythematosus) during baseline
• Month or year of diagnosis of malignancy in SEER was unknown
• Cancer cases who were identified by death certificate or autopsy only in SEER

Other protocol defined inclusion/exclusion criteria could apply

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RA patients treated with abatacept	Non-Interventional	-
RA patients treated with other biologics	Non-Interventional	-
RA patients treated with anti-TNFi's	Non-Interventional	-

Primary Outcome Measures

Name	Time	Method
Incidence of cancer among RA patients treated with anti-TNF's	Approximately 8 years
Incidence of cancer among RA patients treated with other biologics	Approximately 8 years
Incidence of cancer among RA patients treated with abatacept	Approximately 8 years

Secondary Outcome Measures

Name	Time	Method
Incidence of cancer relative to the use of TNFi's in patients taking abatacept	Approximately 8 years
Incidence of cancer relative to the use of other biologic disease modifiers in patients taking abatacept	Approximately 8 years

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Princeton, New Jersey, United States