Effects of Abatacept in Patients With Early Rheumatoid Arthritis (AVERT-2)
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ClinicalTrials.gov Identifier: NCT02504268 |
Recruitment Status :
Completed
First Posted : July 21, 2015
Results First Posted : April 8, 2019
Last Update Posted : June 28, 2021
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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Tracking Information | ||||
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First Submitted Date ICMJE | July 20, 2015 | |||
First Posted Date ICMJE | July 21, 2015 | |||
Results First Submitted Date ICMJE | January 16, 2019 | |||
Results First Posted Date ICMJE | April 8, 2019 | |||
Last Update Posted Date | June 28, 2021 | |||
Actual Study Start Date ICMJE | September 3, 2015 | |||
Actual Primary Completion Date | January 16, 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at Week 24 [ Time Frame: Week 24 ] Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL) SDAI Remission is defined as SDAI <= 3.3.
Using a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI <= 3.3 indicates disease remission and SDAI >26 = high disease activity.
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Original Primary Outcome Measures ICMJE |
Proportion of subjects in Simple Disease Activity Index (SDAI) remission [ Time Frame: Week 24 ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Effects of Abatacept in Patients With Early Rheumatoid Arthritis | |||
Official Title ICMJE | A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive | |||
Brief Summary | The purpose of this study is to determine if abatacept is effective in the treatment of early rheumatoid arthritis. | |||
Detailed Description | Subcutaneous (SC) | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Rheumatoid Arthritis | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
994 | |||
Original Estimated Enrollment ICMJE |
1000 | |||
Actual Study Completion Date ICMJE | March 19, 2020 | |||
Actual Primary Completion Date | January 16, 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia, Czechia, Finland, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Monaco, Netherlands, Peru, Poland, Qatar, Romania, Russian Federation, Singapore, South Africa, Spain, Sweden, Taiwan, United Kingdom, United States | |||
Removed Location Countries | Czech Republic, Puerto Rico, Saudi Arabia, United Arab Emirates | |||
Administrative Information | ||||
NCT Number ICMJE | NCT02504268 | |||
Other Study ID Numbers ICMJE | IM101-550 2015-001275-50 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Bristol-Myers Squibb | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Bristol-Myers Squibb | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Bristol-Myers Squibb | |||
Verification Date | June 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |