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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02504268
Registration number
NCT02504268
Ethics application status
Date submitted
20/07/2015
Date registered
21/07/2015
Date last updated
28/06/2021
Titles & IDs
Public title
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
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Scientific title
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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Secondary ID [1]
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2015-001275-50
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Secondary ID [2]
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IM101-550
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Universal Trial Number (UTN)
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Trial acronym
AVERT-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Abatacept
Treatment: Drugs - Methotrexate
Other interventions - Abatacept Placebo
Other interventions - Methotrexate Placebo
Experimental: Combination Therapy: Abatacept + Methotrexate - Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
Active Comparator: Methotrexate treatment - Methotrexate at least 15mg per week tablet or capsule orally
Placebo Comparator: Abatacept Placebo - Placebo for Abatacept subcutaneous injection once per week
Placebo Comparator: Methotrexate Placebo - Placebo to match Methotrexate capsule orally once per week
Treatment: Drugs: Abatacept
Treatment: Drugs: Methotrexate
Other interventions: Abatacept Placebo
Other interventions: Methotrexate Placebo
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at Week 24
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Assessment method [1]
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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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Timepoint [1]
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Week 24
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Secondary outcome [1]
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Percentage of Participants in Disease Activity Score (DAS)28 - C-reactive Protein (CRP) Remission at Week 24
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Assessment method [1]
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DAS28-CRP = Disease Activity Score 28 based on C-reactive protein DAS28-CRP Remission is defined as DAS28-CRP <= 2.6 Using a logistic regression model that includes treatment arm, stratification variable and baseline measure as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided.
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Timepoint [1]
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Week 24
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Secondary outcome [2]
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Percentage of Participants in SDAI Remission at Week 52
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Assessment method [2]
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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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Timepoint [2]
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Week 52
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Secondary outcome [3]
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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
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Assessment method [3]
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The Modified Total Sharp Score (mTSS) is calculated as the bilateral sum of erosion and Joint Space Narrowing (JSN) scores across all joints of the hands and feet.The score range for mTSS is 0-448. Higher scores indicate more joint damage. The mean change from baseline in TSS using modified Sharp/van der Heijide scores was assessed using a rank-based nonparametric ANCOVA model.
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Timepoint [3]
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Week 52
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Secondary outcome [4]
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Percentage of Participants in Boolean Remission at Week 52
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Assessment method [4]
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Boolean Remission is defined as Tender joint count less than 1, Swollen joint count less than 1, CRP less than 1 mg/dL, patient global assessment less than 1 (on 0 to 10 VAS scale). Logistic regression was used for this endpoint.
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Timepoint [4]
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Week 52
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Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
- 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/09/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/03/2020
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Sample size
Target
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Accrual to date
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Final
994
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Recruitment in Australia
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QLD,TAS,VIC
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Local Institution - Maroochydore
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4558 - Maroochydore
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4215 - Southport
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7000 - Hobart
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3124 - Camberwell
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2450 - Coffs Harbour
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Spain
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State/province [122]
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A Coruna
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Country [123]
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Spain
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Barcelona
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Spain
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Madrid
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Country [125]
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Spain
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Santiago Compostela
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Country [126]
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Sweden
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Goteborg
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Country [127]
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Sweden
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Malmo
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Country [128]
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Sweden
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Stockholm
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Sweden
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Uppsala
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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United Kingdom
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North Yorkshire
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United Kingdom
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Hull
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United Kingdom
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Ethics approval
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Summary
Brief summary
The purpose of this study is to determine if abatacept is effective in the treatment of early
rheumatoid arthritis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02504268
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Public notes
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Contacts
Principal investigator
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Bristol Myers Squibb
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Bristol-Myers Squibb
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02504268
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