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OpenTrials
Active, not recruiting

NCT Number: NCT01088360

Safety Study of Abatacept to Treat Rheumatoid Arthritis (B)

The purpose of this study is to compare the incidence rates of targeted infections, malignancies and mortality among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent
  • Diagnosis of rheumatoid arthritis
  • > 18 years at index treatment initiation or switch
  • Starting treatment with abatacept or new disease-modifying anti-rheumatic drug (including switching or adding) or biologic disease modifying drug.
  • Read/write English

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Key safety outcomes (targeted infections, malignancies, mortality)

    Time frame: Every 6 months throughout the study

Secondary outcomes

  1. Patient-reported infusion reactions

    Time frame: Every 6 months throughout the study

  2. Multiple sclerosis, lupus, and psoriasis

    Time frame: Every 6 months throughout the study

  3. Adverse events in pregnant women who receive abatacept

    Time frame: Every 6 months throughout the study

  4. Adverse events in subjects on abatacept who receive concomitant biologics

    Time frame: Every 6 months throughout the study

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • National Data Bank for Rheumatic Diseases (NDB)

Registry information

Official study title

An Observational Cohort to Assess Safety and Outcomes in Patients Treated With Abatacept and Other Anti-Rheumatic Therapies

Important dates

Study start
2005
Primary completion
2029
Study completion
2029
First posted
Mar 17, 2010
Registry last updated
Jan 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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