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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.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02504268
Date of registration: 20/07/2015
Prospective Registration: Yes
Primary sponsor: Bristol-Myers Squibb
Public title: Effects of Abatacept in Patients With Early Rheumatoid Arthritis AVERT-2
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
Date of first enrolment: August 31, 2015
Target sample size: 1067
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02504268
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
Argentina Australia Austria Brazil Canada Chile Colombia Czech Republic
Czechia Finland France Germany Hungary Israel Italy Japan
Korea, Republic of Mexico Monaco Netherlands Peru Poland Puerto Rico Qatar
Romania Russian Federation Saudi Arabia Singapore South Africa Spain Sweden Taiwan
United Arab Emirates United Kingdom United States
Contacts
Name:     Bristol Myers Squibb
Address: 
Telephone:
Email:
Affiliation:  Bristol-Myers Squibb
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Abatacept
Drug: Methotrexate
Other: Abatacept Placebo
Other: Methotrexate Placebo
Primary Outcome(s)
Percentage of Subjects in Simple Disease Activity Index (SDAI) Remission at Week 24 [Time Frame: Week 24]
Secondary Outcome(s)
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]
Percentage of Subjects in Boolean Remission at Week 52 [Time Frame: Week 52]
Percentage of Subjects in Disease Activity Score (DAS)28 - C-reactive Protein (CRP) Remission at Week 24 [Time Frame: Week 24]
Percentage of Subjects in SDAI Remission at Week 52 [Time Frame: Week 52]
Secondary ID(s)
2015-001275-50
IM101-550
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 08/04/2019
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02504268
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