Rheumatoid Arthritis Clinical Trial
Official title:
Real World Effectiveness of Abatacept in Rheumatoid Arthritis Patients: a Prospective, Single-arm, Multi-center Observational Study in Taiwan
NCT number | NCT02335606 |
Other study ID # | IM101-440 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 6, 2014 |
Est. completion date | December 31, 2018 |
Verified date | January 2022 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Abatacept Registry in Taiwan
Status | Completed |
Enrollment | 213 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Local Institution | Taipei |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | ||
Secondary | The time to treatment discontinuation in RA patients treated with abatacept | Treatment discontinuation is defined as patients who cease treatment for > 8 weeks | at 6, 9, 12, 18, and 24months after study participation | |
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04226131 -
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
|
N/A | |
Completed |
NCT04171414 -
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT02833350 -
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
|
Phase 2 | |
Completed |
NCT04255134 -
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
|
Phase 4 | |
Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
Recruiting |
NCT06005220 -
SBD121, a Synbiotic Medical Food for RA Management
|
N/A | |
Recruiting |
NCT05451615 -
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT05054920 -
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT02037737 -
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
|
N/A | |
Recruiting |
NCT04079374 -
Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
|
Phase 3 | |
Completed |
NCT02504268 -
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
|
Phase 3 | |
Recruiting |
NCT05496855 -
Remote Care in People With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Recruiting |
NCT06103773 -
A Study of Single and Multiple Oral Doses of TollB-001
|
Phase 1 | |
Recruiting |
NCT06031415 -
Study of GS-0272 in Participants With Rheumatoid Arthritis
|
Phase 1 | |
Completed |
NCT05999266 -
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
|
||
Recruiting |
NCT05302934 -
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
|
||
Recruiting |
NCT04169100 -
Novel Form of Acquired Long QT Syndrome
|
Phase 4 |