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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/NCT04909801




Registration number
NCT04909801
Ethics application status
Date submitted
28/05/2021
Date registered
2/06/2021
Date last updated
7/11/2023

Titles & IDs
Public title
A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Scientific title
A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment With Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive Rheumatoid Arthritis Who Have "Shared Epitope" HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate
Secondary ID [1] 0 0
2020-000350-96
Secondary ID [2] 0 0
IM101-863
Universal Trial Number (UTN)
Trial acronym
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
Treatment: Drugs - Abatacept
Treatment: Drugs - Adalimumab
Treatment: Drugs - Methotrexate

Experimental: Arm 1: Abatacept + Methotrexate -

Experimental: Arm 2: (Adalimumab + Methotrexate) followed by (Abatacept + Methotrexate) -


Treatment: Drugs: Abatacept
Abatacept SC (125 mg) once weekly

Treatment: Drugs: Adalimumab
Adalimumab SC (40 mg) once every 2 weeks

Treatment: Drugs: Methotrexate
Methotrexate oral/parenteral maximum tolerated dose (minimum 15 mg and maximum 25 mg weekly)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of shared epitope-positive (SE+) participants meeting 50% improvement in American College of Rheumatology criteria (ACR50) response
Timepoint [1] 0 0
At week 24
Secondary outcome [1] 0 0
Proportion of SE+ participants achieving Disease Activity Score 28-joint count calculated using C-reactive protein (DAS28-CRP) remission (DAS28-CRP < 2.6)
Timepoint [1] 0 0
At week 24
Secondary outcome [2] 0 0
Proportion of whole study population participants meeting ACR50 response
Timepoint [2] 0 0
At week 24
Secondary outcome [3] 0 0
Proportion of SE+ participants achieving Clinical Disease Activity Index (CDAI) remission (CDAI = 2.8)
Timepoint [3] 0 0
At week 24
Secondary outcome [4] 0 0
Mean change from baseline in SE+ participant-reported pain by visual analog scale (VAS)
Timepoint [4] 0 0
At week 24
Secondary outcome [5] 0 0
Proportion of SE+ subset achieving 20% improvement in American College of Rheumatology criteria (ACR20) responses
Timepoint [5] 0 0
Up to 104 weeks
Secondary outcome [6] 0 0
Proportion of SE+ whole population achieving ACR20 responses
Timepoint [6] 0 0
Up to 104 weeks
Secondary outcome [7] 0 0
Proportion of SE+ subset achieving 50% improvement in American College of Rheumatology criteria (ACR50) responses
Timepoint [7] 0 0
Up to 104 weeks
Secondary outcome [8] 0 0
Proportion of SE+ whole population achieving ACR50 responses
Timepoint [8] 0 0
Up to 104 weeks
Secondary outcome [9] 0 0
Proportion of SE+ subset achieving 70% improvement in American College of Rheumatology criteria (ACR70) responses
Timepoint [9] 0 0
Up to 104 weeks
Secondary outcome [10] 0 0
Proportion of SE+ whole population achieving ACR70 responses
Timepoint [10] 0 0
Up to 104 weeks
Secondary outcome [11] 0 0
Proportion of SE+ subset achieving Disease Activity Score (DAS) remission
Timepoint [11] 0 0
Up to 104 weeks
Secondary outcome [12] 0 0
Proportion of SE+ whole population achieving DAS remission
Timepoint [12] 0 0
Up to 104 weeks
Secondary outcome [13] 0 0
Proportion of SE+ subset achieving Clinical Disease Activity Index (CDAI) remission
Timepoint [13] 0 0
Up to 104 weeks
Secondary outcome [14] 0 0
Proportion of SE+ whole population achieving CDAI remission
Timepoint [14] 0 0
Up to 104 weeks
Secondary outcome [15] 0 0
Proportion of SE+ subset achieving Simple Disease Activity Index (SDAI) remission over the Single-blind Treatment Period (SBTP)
Timepoint [15] 0 0
Up to 104 weeks
Secondary outcome [16] 0 0
Proportion of SE+ subset achieving Simple Disease Activity Index (SDAI) remission over the Open-label Treatment Period (OLTP)
Timepoint [16] 0 0
Up to 104 weeks
Secondary outcome [17] 0 0
Proportion of SE+ whole population achieving SDAI remission over the SBTP
Timepoint [17] 0 0
Up to 104 weeks
Secondary outcome [18] 0 0
Proportion of SE+ whole population achieving SDAI remission over the OLTP
Timepoint [18] 0 0
Up to 104 weeks
Secondary outcome [19] 0 0
Mean changes from baseline in DAS28-CRP
Timepoint [19] 0 0
Up to 104 weeks
Secondary outcome [20] 0 0
Mean changes from baseline in CDAI
Timepoint [20] 0 0
Up to 104 weeks
Secondary outcome [21] 0 0
Mean changes from baseline in SDAI over the SBTP
Timepoint [21] 0 0
Up to 104 weeks
Secondary outcome [22] 0 0
Mean changes from baseline in SDAI over the OLTP
Timepoint [22] 0 0
Up to 104 weeks
Secondary outcome [23] 0 0
Mean changes from baseline in the 7 ACR core components over the SBTP
Timepoint [23] 0 0
Up to 104 weeks
Secondary outcome [24] 0 0
Mean changes from baseline in the 7 ACR core components over the OLTP
Timepoint [24] 0 0
Up to 104 weeks
Secondary outcome [25] 0 0
Mean change from baseline in 36-item Short Form Survey (SF-36) in SE+ subset at week 24 and week 104
Timepoint [25] 0 0
Up to 104 weeks
Secondary outcome [26] 0 0
Mean change from baseline in SF-36 in SE+ whole population at week 24 and week 104
Timepoint [26] 0 0
Up to 104 weeks

Eligibility
Key inclusion criteria
- Early rheumatoid arthritis (RA), defined as symptoms of RA that started = 12 months
prior to screening and satisfied the American College of Rheumatology/European League
Against Rheumatism (ACR/EULAR) 2010 criteria for the classification of RA at some
point during the 12-month period

- Naïve to any targeted (biologic or nonbiologic) disease-modifying antirheumatic drugs
(DMARDs), conventional synthetic DMARDs other than methotrexate (MTX), or
investigational therapies for RA

- Treated with MTX for at least 12 weeks, with a stable dose of oral or parenteral MTX
for at least 4 weeks prior to randomization

- Anti-cyclic citrullinated peptide-2 (Anti-CCP-2) test that is > 3× the upper limit of
normal and are positive for rheumatoid factor (RF) according to central lab testing
during screening

- At least a Disease Activity Score 28-joint count calculated using C-reactive protein
(DAS28-CRP) = 3.2 at screening

- At least 3 tender and at least 3 swollen joints at screening and at randomization
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Women who are breastfeeding

- Autoimmune disease other than RA (e.g., psoriasis, systemic lupus erythematosus [SLE],
vasculitis, seronegative spondyloarthritis, inflammatory bowel disease, Sjogren's
syndrome) or currently active fibromyalgia

- History of or current inflammatory joint disease other than RA (e.g., psoriatic
arthritis, gout, reactive arthritis, Lyme disease)

- At risk for tuberculosis

- Recent acute infection

- History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis,
osteomyelitis, bronchiectasis)

- History of infection of a joint prosthesis or artificial joint

- History of systemic fungal infections (such as histoplasmosis, blastomycosis, or
coccidiomycosis)

- History of primary immunodeficiency

- Current clinical findings or a history of a demyelinating disorder

- 5 or more joints cannot be assessed for tenderness or swelling

Other protocol-defined inclusion/exclusion criteria apply

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 assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/09/2025
Actual
Sample size
Target
Accrual to date
Final
327
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - 0072 - Botany
Recruitment hospital [2] 0 0
Local Institution - 0062 - Paramatta
Recruitment hospital [3] 0 0
Local Institution - 0063 - Maroochydore
Recruitment hospital [4] 0 0
Local Institution - 0102 - Woodville South
Recruitment hospital [5] 0 0
Local Institution - 0064 - Camberwell
Recruitment hospital [6] 0 0
Local Institution - 0065 - Geelong
Recruitment hospital [7] 0 0
Local Institution - 0105 - Ivanhoe
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2150 - Paramatta
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
5001 - Woodville South
Recruitment postcode(s) [5] 0 0
3124 - Camberwell
Recruitment postcode(s) [6] 0 0
3220 - Geelong
Recruitment postcode(s) [7] 0 0
3079 - Ivanhoe
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Argentina
State/province [13] 0 0
Buenos Aires
Country [14] 0 0
Argentina
State/province [14] 0 0
Tucuman
Country [15] 0 0
Argentina
State/province [15] 0 0
Cordoba
Country [16] 0 0
Czechia
State/province [16] 0 0
Brno
Country [17] 0 0
Czechia
State/province [17] 0 0
Praha 2
Country [18] 0 0
France
State/province [18] 0 0
Montpellier
Country [19] 0 0
France
State/province [19] 0 0
Rouen
Country [20] 0 0
France
State/province [20] 0 0
Strasbourg
Country [21] 0 0
France
State/province [21] 0 0
Toulouse
Country [22] 0 0
Germany
State/province [22] 0 0
Berlin
Country [23] 0 0
Germany
State/province [23] 0 0
Bonn
Country [24] 0 0
Germany
State/province [24] 0 0
Freiburg
Country [25] 0 0
Germany
State/province [25] 0 0
Hamburg
Country [26] 0 0
Germany
State/province [26] 0 0
Planegg
Country [27] 0 0
Italy
State/province [27] 0 0
Catania
Country [28] 0 0
Italy
State/province [28] 0 0
Pavia
Country [29] 0 0
Italy
State/province [29] 0 0
Perugia
Country [30] 0 0
Italy
State/province [30] 0 0
Roma
Country [31] 0 0
Japan
State/province [31] 0 0
Aichi
Country [32] 0 0
Japan
State/province [32] 0 0
Fukuoka
Country [33] 0 0
Japan
State/province [33] 0 0
Hokkaido
Country [34] 0 0
Japan
State/province [34] 0 0
Miyagi
Country [35] 0 0
Japan
State/province [35] 0 0
Nagasaki
Country [36] 0 0
Japan
State/province [36] 0 0
Saitama
Country [37] 0 0
Japan
State/province [37] 0 0
Tokyo
Country [38] 0 0
Mexico
State/province [38] 0 0
Distrito Federal
Country [39] 0 0
Mexico
State/province [39] 0 0
Jalisco
Country [40] 0 0
Mexico
State/province [40] 0 0
SAN LUIS Potosi
Country [41] 0 0
Mexico
State/province [41] 0 0
Yucatán
Country [42] 0 0
Mexico
State/province [42] 0 0
Chihuahua
Country [43] 0 0
Poland
State/province [43] 0 0
Kujawsko-pomorskie
Country [44] 0 0
Poland
State/province [44] 0 0
Bydgoszcz
Country [45] 0 0
Poland
State/province [45] 0 0
Elblag
Country [46] 0 0
Spain
State/province [46] 0 0
A Coruña
Country [47] 0 0
Spain
State/province [47] 0 0
Madrid
Country [48] 0 0
Spain
State/province [48] 0 0
Santander
Country [49] 0 0
Switzerland
State/province [49] 0 0
Basel
Country [50] 0 0
Switzerland
State/province [50] 0 0
St. Gallen
Country [51] 0 0
Taiwan
State/province [51] 0 0
Kaohsiung Niao Sung Dist
Country [52] 0 0
Taiwan
State/province [52] 0 0
New Taipei City
Country [53] 0 0
Taiwan
State/province [53] 0 0
Taichung City
Country [54] 0 0
Taiwan
State/province [54] 0 0
Taichung
Country [55] 0 0
Taiwan
State/province [55] 0 0
Tainan
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Staffordshire
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Hull
Country [58] 0 0
United Kingdom
State/province [58] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the superiority in efficacy of abatacept compared
with adalimumab, on background methotrexate, in adults with early, seropositive, and shared
epitope-positive rheumatoid arthritis and an inadequate methotrexate response.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04909801
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04909801