Clinical trial NCT03670667: A Study to Determine the Risk of Cancer in Rheumatoid Arthritis (RA) Patients Who Use Abatacept and Other Biologic Agents
Official title: The Risk of Cancer Associated With the Use of Abatacept and Other Biologic Agents Among Rheumatoid Arthritis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-09-13
Enrollment: 1132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population will include patients who had incident cancer diagnosed from the SEER-Medicare linked database

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


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of cancer among RA patients treated with abatacept
timeFrame: Approximately 8 years
measure: Incidence of cancer among RA patients treated with anti-TNF's
timeFrame: Approximately 8 years
measure: Incidence of cancer among RA patients treated with other biologics
timeFrame: Approximately 8 years
Secondary outcomes:
measure: Incidence of cancer relative to the use of TNFi's in patients taking abatacept
timeFrame: Approximately 8 years
measure: Incidence of cancer relative to the use of other biologic disease modifiers in patients taking abatacept
timeFrame: Approximately 8 years
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Local Institution
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: