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

NCT03670667 | Completed

• 1 other identifier: IM101-674
• Study Type: observational
• Target: 1,132
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

• Incidence of cancer among RA patients treated with abatacept

  Approximately 8 years

• 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

Secondary Outcomes (2)

• 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

Study Arms (3)

RA patients treated with abatacept

Other: Non-Interventional

RA patients treated with anti-TNFi's

Other: Non-Interventional

RA patients treated with other biologics

Other: Non-Interventional

Interventions

Non-Interventional OTHER

Non-Interventional

RA patients treated with abatacept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population will include patients who had incident cancer diagnosed from the SEER-Medicare linked database

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Princeton, New Jersey, 08540, United States

Location

Related Links

• BMS Clinical Trial Information

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 13, 2018
• Study Start: February 22, 2017
• Primary Completion: March 29, 2019
• Study Completion: March 29, 2019
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

US (1)