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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 July 2021 |
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Main ID: |
NCT02504268 |
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Date of registration:
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20/07/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of Abatacept in Patients With Early Rheumatoid Arthritis
AVERT-2 |
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Scientific title:
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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 |
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Date of first enrolment:
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September 3, 2015 |
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Target sample size:
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994 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02504268 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Australia
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Austria
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Brazil
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Canada
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Chile
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Colombia
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Czech Republic
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Czechia
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Finland
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France
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Germany
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Hungary
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Israel
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Italy
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Japan
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Korea, Republic of
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Mexico
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Monaco
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Netherlands
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Peru
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Poland
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Puerto Rico
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Qatar
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Romania
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Russian Federation
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Saudi Arabia
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Singapore
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South Africa
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Spain
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Sweden
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Taiwan
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United Arab Emirates
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United Kingdom
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United States
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Contacts
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Name:
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Bristol Myers Squibb |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Inclusion Criteria:
- Rheumatoid arthritis (RA) diagnosis less than 6 months
- CRP > 3 mg/L or Erythrocyte Sedimentation Rate (ESR) = 28 mm/h
- At least 3 swollen and 3 tender joints
- Anti-citrullinated protein antibodies (ACPA) positive
Exclusion Criteria:
- At risk for tuberculosis
- Have acute infection
- Have chronic or recurrent bacterial or serious latent viral infection
- History of malignancies in the last 5 years except squamous skin, basal skin or
cervical carcinoma
- Previous treatment with any conventional or biologic Disease-modifying anti rheumatic
drugs (DMARD)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Abatacept
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Other: Abatacept Placebo
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Drug: Methotrexate
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Other: Methotrexate Placebo
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Primary Outcome(s)
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Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at Week 24
[Time Frame: Week 24]
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Secondary Outcome(s)
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Mean Change From Baseline in Radiographic Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijide Total Sharp Scores (TSS) at Week 52
[Time Frame: Week 52]
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Percentage of Participants in SDAI Remission at Week 52
[Time Frame: Week 52]
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Percentage of Participants in Boolean Remission at Week 52
[Time Frame: Week 52]
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Percentage of Participants in Disease Activity Score (DAS)28 - C-reactive Protein (CRP) Remission at Week 24
[Time Frame: Week 24]
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Secondary ID(s)
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2015-001275-50
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IM101-550
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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