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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2015-001275-50
Secondary ID [2] 0 0
IM101-550
Universal Trial Number (UTN)
Trial acronym
AVERT-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Percentage of Participants in Disease Activity Score (DAS)28 - C-reactive Protein (CRP) Remission at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percentage of Participants in SDAI Remission at Week 52
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Percentage of Participants in Boolean Remission at Week 52
Timepoint [4] 0 0
Week 52

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/03/2020
Sample size
Target
Accrual to date
Final
994
Recruitment in Australia
Recruitment state(s)
QLD,TAS,VIC
Recruitment hospital [1] 0 0
Local Institution - Maroochydore
Recruitment hospital [2] 0 0
Local Institution - Southport
Recruitment hospital [3] 0 0
Local Institution - Hobart
Recruitment hospital [4] 0 0
Local Institution - Camberwell
Recruitment hospital [5] 0 0
Local Institution - Coffs Harbour
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
7000 - Hobart
Recruitment postcode(s) [4] 0 0
3124 - Camberwell
Recruitment postcode(s) [5] 0 0
2450 - Coffs Harbour
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02504268