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

NCT02335606 | Completed

• 1 other identifier: IM101-440
• Study Type: observational
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

Abatacept Registry in Taiwan

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

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

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

  approximately 24 months

Secondary Outcomes (5)

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

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

• The time to treatment discontinuation in RA patients treated with abatacept

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

• 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

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

• 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

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

• 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

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

Study Arms (1)

Patients treating with Abatacept

Patients who are abatacept naive and are initiating abatacept treatment (either IV or SC) including those that are switching from another bDMARD, as well as, patients currently being treated with IV or SC abatacept some of which may have switched from IV abatacept to SC abatacept

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital : Research based hospital centers, Teaching hospitals affiliated with medical schools, National/Regional medical centers and/or in which thought leaders are employed

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Taipei, 105, Taiwan

Location

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

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: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 12, 2015
• Study Start: August 6, 2014
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: January 21, 2022

Record last verified: 2022-01

Locations

TW (1)