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

Rheumatoid Arthritis Clinical Trial

Official title:

The Risk of Cancer Associated With the Use of Abatacept and Other Biologic Agents Among Rheumatoid Arthritis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03670667
• Other study ID #: IM101-674
• Status: Completed
• Start date: February 22, 2017
• Est. completion date: March 29, 2019

Study information

• Verified date: May 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1132
• Est. completion date: March 29, 2019
• Est. primary completion date: March 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Non-Interventional
Non-Interventional
• Non-Interventional
Non-Interventional
• Non-Interventional
Non-Interventional

Locations

Country	Name	City	State
United States	Local Institution	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cancer among RA patients treated with abatacept		Approximately 8 years
Primary	Incidence of cancer among RA patients treated with anti-TNF's		Approximately 8 years
Primary	Incidence of cancer among RA patients treated with other biologics		Approximately 8 years
Secondary	Incidence of cancer relative to the use of TNFi's in patients taking abatacept		Approximately 8 years
Secondary	Incidence of cancer relative to the use of other biologic disease modifiers in patients taking abatacept		Approximately 8 years

External Links

•   BMS Clinical Trial Information