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

Bristol-Myers Squibb (BMS)

Status

Completed

Conditions

Rheumatoid Arthritis

Treatments

Other: Non-Interventional

Study type

Observational

Funder types

Industry

Identifiers

NCT03670667

IM101-674

Details and patient eligibility

About

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

Enrollment

1,132 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

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