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Completed

NCT Number: NCT02335606

Real World Effectiveness of Abatacept in Rheumatoid Arthritis Patients: a Prospective, Single-arm, Open-label, Multi-center Observational Study in Taiwan

Abatacept Registry in Taiwan

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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

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Taipei, 105, Taiwan

Who can participate

Healthy volunteers accepted: No

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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

  • ≥ 20 years of age
  • Who give informed consent
  • Confirmed diagnosis of RA (as defined by American College of Rheumatology revised 1987 criteria) and has ≥ 4 of the criteria listed below for ≥6 weeks before study enrollment
  • Who self-pay or who are reimbursed by BNHI for abatacept treatment
  • With latent TB or who are receiving anti-TB treatment (INH 300 mg, QD) 1 month prior to using abatacept and continuously up to a total of 9 months Willing to follow Taiwan Risk Management Plan guidelines as required by Taiwan health authorities
  • Are being treated with abatacept or are abatacept treatment naïve and are initiating abatacept therapy

Exclusion criteria

  • Pregnant or breast feeding
  • With active TB
  • HBsAg (+)and/or Anti-HCV(+) and/or HBV DNA(+)
  • Have cancer (patients who were treated and have no sign of cancer for > 10 years can be included)
  • Are allergic to abatacept
  • Enrolled in other RA clinical studies

Treatment and study plan

Primary outcomes

  1. The retention rate of abatacept therapy over 24 months in RA patients under real world clinical practice in Taiwan.

    Time frame: approximately 24 months

    Treatment retention rate is defined as the proportion of subjects who use abatacept for 24 months

Secondary outcomes

  1. The retention rate (%) of abatacept therapy at 6, 9, 12, and 18 months in RA patients

    Time frame: at 6, 9, 12, 18, and 24months after study participation

  2. The time to treatment discontinuation in RA patients treated with abatacept

    Time frame: at 6, 9, 12, 18, and 24months after study participation

    Treatment discontinuation is defined as patients who cease treatment for > 8 weeks

  3. The proportion of patients achieving DAS28 ≤ 2.6, 2.6 < DAS28 ≤ 3.2, 3.2 < DAS28 ≤ 5.1, DAS> 5.1 at 6, 9, 12, 18, and 24months

    Time frame: at 6, 9, 12, 18, and 24months after study participation

  4. The major reason for treatment discontinuation (eg, lack of efficacy, severe adverse drug reactions, switch from abatacept to another RA medication, financial issues, etc) at 6, 9, 12, 18, and 24 months

    Time frame: at 6, 9, 12, 18, and 24months after study participation

  5. The demographic, clinical presentation, and disease management a composite measure of RA patients who are using abatacept (either formulation) or are abatacept naïve at Month 6, 9, 12, 18, and 24

    Time frame: at 6, 9, 12, 18, and 24months after study participation

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Real World Effectiveness of Abatacept in Rheumatoid Arthritis Patients: a Prospective, Single-arm, Multi-center Observational Study in Taiwan

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 12, 2015
Registry last updated
Jan 21, 2022

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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