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Trial record 61 of 137 for:    "Connective Tissue Disease" | "Abatacept"

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

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ClinicalTrials.gov Identifier: NCT02335606
Recruitment Status : Active, not recruiting
First Posted : January 12, 2015
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
Abatacept Registry in Taiwan

Condition or disease
Rheumatoid Arthritis

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 318 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Real World Effectiveness of Abatacept in Rheumatoid Arthritis Patients: a Prospective, Single-arm, Multi-center Observational Study in Taiwan
Actual Study Start Date : October 6, 2013
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Group/Cohort
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02335606


Locations
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Taiwan
Local Institution
Taipei, Taiwan, 105
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02335606     History of Changes
Other Study ID Numbers: IM101-440
First Posted: January 12, 2015    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
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Connective Tissue Diseases
Abatacept
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents