Safety Study of Abatacept in Rheumatoid Arthritis Participants

NCT03696173 | Completed

• 1 other identifier: IM101-605
• Study Type: observational
• Target: 5,800
• Locations: 1 country
• Sites: 1

Brief Summary

A observational study to assess whether biologic disease-modifying (BDM) treatment initiation with abatacept for rheumatoid arthritis is associated with an increased risk of serious infection and cancer

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (4)

• Incidence of increased risk of serious infection while taking abatacept

  With methotrexate

  Approximately 7 years

• Incidence of malignancy while taking abatacept

  With methotrexate

  Approximately 7 years

• Incidence of increased risk of serious infection while taking abatacept

  Without methotrexate

  Approximately 7 years

• Incidence of malignancy while taking abatacept

  Without methotrexate

  Approximately 7 years

Study Arms (2)

Participants taking abatacept

Other: Non-Interventional

Participants taking abatacept with methotrexate

Other: Non-Interventional

Interventions

Non-Interventional OTHER

Non-Interventional

Participants taking 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

Rheumatoid arthritis (RA) participant, population-based cohort study approach within the US-based Truven MarketScan population and Supplemental US Medicare database

You may qualify if:

• Patient initiates BDM treatment with at least one claim for the treatment. Patients will be presumed to be new users of a treatment if there is no claim for the drug or any other BDM in the 180 days prior to the cohort entry date
• Patient has at least two diagnoses for RA in the patient's history prior to and including the entry date or within the 180 days after the entry date
• Patient is aged 18 years or older on the entry date
• Patient was enrolled in the database for at least 180 days before the entry date

You may not qualify if:

• Patient is younger than 18 years on the entry date
• Patients who receive abatacept and another biologic simultaneously
• Patients who have an outcome diagnosis in the baseline period will be excluded from the cohort analyses for that outcome

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Princeton, New Jersey, 08540, United States

Location

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form

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: October 3, 2018
• First Posted: October 4, 2018
• Study Start: December 17, 2015
• Primary Completion: June 29, 2018
• Study Completion: June 29, 2018
• Last Updated: October 4, 2018

Record last verified: 2018-09

Locations

US (1)