Back to resultsAbatacept Post-marketing Clinical Study in Japan
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Abatacept
Placebo matching with Abatacept
Methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- MTX inadequate responder
- Biologic Naïve
- Functional class I, II or III
- ≥6 swollen and ≥6 tender joints
- C-reactive protein (CRP) ≥2.0mg/dl or erythrocyte sedimentation rate (ESR) ≥28 mm/hr
- Anti-cyclic citrullinated peptide (CCP) antibody positive
- Have erosion
Exclusion Criteria:
- Any other rheumatic disease
- Active angiitis on main organs excluding rheumatoid nodule
Sites / Locations
- Local Institution
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group 1: Abatacept + Methotrexate (MTX)
Group 2: Placebo matching with Abatacept + Methotrexate
Arm Description
Abatacept 10 mg/kg solution intravenous (IV) infusion, once monthly for 12 months Methotrexate ≥6 mg/week for 12 months
Placebo matching with Abatacept 0 mg/kg solution, intravenous (IV) infusion once monthly for 12 months Methotrexate ≥6 mg/week for 12 months
Outcomes
Primary Outcome Measures
American College of Rheumatology (ACR) 20% response rate
Change from baseline in Total Sharp Score (TSS) using the Modified van der Heijde Sharp (vdH-S) method to 6 months (Week 24)
Secondary Outcome Measures
Change from baseline in Disease Activity Score-28 (DAS28)-CRP to 4 months (Week16)
Non-progressors rate for the structural damage
The non-progressors rate is defined as the proportion of subjects meeting the change from baseline in the TSS at 6 months less than or equal to the smallest detectable difference (SDD) and/or the smallest detectable change (SDC)
ACR 50 response rates
ACR 70 response rates
Safety and tolerability will be measured based on clinical Adverse Events, vital signs, and laboratory abnormalities
Full Information
NCT ID
NCT01758198
First Posted
December 19, 2012
Last Updated
May 12, 2017
Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01758198
Brief Title
Abatacept Post-marketing Clinical Study in Japan
Official Title
A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate vs. Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 11, 2013 (Actual)
Primary Completion Date
December 26, 2016 (Actual)
Study Completion Date
December 26, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the clinical efficacy including joint damage progression and safety of Abatacept plus Methotrexate (MTX) to placebo plus MTX.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
405 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Abatacept + Methotrexate (MTX)
Arm Type
Experimental
Arm Description
Abatacept 10 mg/kg solution intravenous (IV) infusion, once monthly for 12 months
Methotrexate ≥6 mg/week for 12 months
Arm Title
Group 2: Placebo matching with Abatacept + Methotrexate
Arm Type
Placebo Comparator
Arm Description
Placebo matching with Abatacept 0 mg/kg solution, intravenous (IV) infusion once monthly for 12 months
Methotrexate ≥6 mg/week for 12 months
Intervention Type
Biological
Intervention Name(s)
Abatacept
Other Intervention Name(s)
BMS-188667 (Orencia)
Intervention Type
Drug
Intervention Name(s)
Placebo matching with Abatacept
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Primary Outcome Measure Information:
Title
American College of Rheumatology (ACR) 20% response rate
Time Frame
4 months (week 16)
Title
Change from baseline in Total Sharp Score (TSS) using the Modified van der Heijde Sharp (vdH-S) method to 6 months (Week 24)
Time Frame
Baseline (Day 1), 6 months (Week 24)
Secondary Outcome Measure Information:
Title
Change from baseline in Disease Activity Score-28 (DAS28)-CRP to 4 months (Week16)
Time Frame
Baseline (Day 1), 4 months (Week 16)
Title
Non-progressors rate for the structural damage
Description
The non-progressors rate is defined as the proportion of subjects meeting the change from baseline in the TSS at 6 months less than or equal to the smallest detectable difference (SDD) and/or the smallest detectable change (SDC)
Time Frame
Baseline (Day 1), 6 months (Week 24)
Title
ACR 50 response rates
Time Frame
4 months (Week16)
Title
ACR 70 response rates
Time Frame
4 months (Week16)
Title
Safety and tolerability will be measured based on clinical Adverse Events, vital signs, and laboratory abnormalities
Time Frame
12 months (Week52)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
MTX inadequate responder
Biologic Naïve
Functional class I, II or III
≥6 swollen and ≥6 tender joints
C-reactive protein (CRP) ≥2.0mg/dl or erythrocyte sedimentation rate (ESR) ≥28 mm/hr
Anti-cyclic citrullinated peptide (CCP) antibody positive
Have erosion
Exclusion Criteria:
Any other rheumatic disease
Active angiitis on main organs excluding rheumatoid nodule
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Kamogawa-city
State/Province
Chiba
ZIP/Postal Code
296-8602
Country
Japan
Facility Name
Local Institution
City
Kasamatsu-town
State/Province
Gifu
ZIP/Postal Code
501-6061
Country
Japan
Facility Name
Local Institution
City
Kakogawa-city
State/Province
Hyogo
ZIP/Postal Code
675-8611
Country
Japan
Facility Name
Local Institution
City
Yokohama-city
State/Province
Kanagawa
ZIP/Postal Code
245-8575
Country
Japan
Facility Name
Local Institution
City
Kurashiki-city
State/Province
Okayama
ZIP/Postal Code
710-8602
Country
Japan
Facility Name
Local Institution
City
Izumisano-city
State/Province
Osaka
ZIP/Postal Code
598-0048
Country
Japan
Facility Name
Local Institution
City
Fujieda-city
State/Province
Shizuoka
ZIP/Postal Code
426-8677
Country
Japan
Facility Name
Local Institution
City
Toyama-city
State/Province
Toyama
ZIP/Postal Code
930-8550
Country
Japan
Facility Name
Local Institution
City
Shimonoseki-city
State/Province
Yamaguchi
ZIP/Postal Code
750-8520
Country
Japan
Facility Name
Local Institution
City
Asahi
ZIP/Postal Code
289-2511
Country
Japan
Facility Name
Local Institution
City
Fuchu
ZIP/Postal Code
183-8524
Country
Japan
Facility Name
Local institution
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Local Institution
City
Fukuoka
ZIP/Postal Code
813-0017
Country
Japan
Facility Name
Local institution
City
Funabashi
ZIP/Postal Code
274-0053
Country
Japan
Facility Name
Local Institution
City
Hakodate
ZIP/Postal Code
040-8611
Country
Japan
Facility Name
Local Institution
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Local Institution
City
Hitachi
ZIP/Postal Code
316-0015
Country
Japan
Facility Name
Local institution
City
Hokkaido
ZIP/Postal Code
078-8243
Country
Japan
Facility Name
Local Institution
City
Iizuka
ZIP/Postal Code
820-8505
Country
Japan
Facility Name
Local Institution
City
Kagoshima
ZIP/Postal Code
890-0067
Country
Japan
Facility Name
Local Institution
City
Kagoshima
ZIP/Postal Code
891-0133
Country
Japan
Facility Name
Local Institution
City
Kanazawa
ZIP/Postal Code
920-8616
Country
Japan
Facility Name
Local Institution
City
Kasama
ZIP/Postal Code
309-1793
Country
Japan
Facility Name
Local Institution
City
Kato
ZIP/Postal Code
673-1462
Country
Japan
Facility Name
Local Institution
City
Kitakyushu
ZIP/Postal Code
800-0031
Country
Japan
Facility Name
Local Institution
City
Kitakyushu
ZIP/Postal Code
800-0296
Country
Japan
Facility Name
Local Institution
City
Kitakyushu
ZIP/Postal Code
807-8556
Country
Japan
Facility Name
Local Institution
City
Kitamoto
ZIP/Postal Code
364-8501
Country
Japan
Facility Name
Local institution
City
Kobe
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Local institution
City
Kobe
ZIP/Postal Code
654-0047
Country
Japan
Facility Name
Local Institution
City
Kochi
ZIP/Postal Code
781-0112
Country
Japan
Facility Name
Local Institution
City
Koshi
ZIP/Postal Code
861-1196
Country
Japan
Facility Name
Local institution
City
Kumamoto
ZIP/Postal Code
862-0976
Country
Japan
Facility Name
Local Institution
City
Matsumoto
ZIP/Postal Code
390-8601
Country
Japan
Facility Name
Local Institution
City
Nagano
ZIP/Postal Code
380-8582
Country
Japan
Facility Name
Local Institution
City
Nagaoka
ZIP/Postal Code
940-2085
Country
Japan
Facility Name
Local Institution
City
Nagasaki
ZIP/Postal Code
850-0832
Country
Japan
Facility Name
Local Institution
City
Nagoya
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Local Institution
City
Nagoya
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Local Institution
City
Narashino
ZIP/Postal Code
275-0006
Country
Japan
Facility Name
Local Institution
City
Narita
ZIP/Postal Code
286-0041
Country
Japan
Facility Name
Local Institution
City
Okayama
ZIP/Postal Code
700-8607
Country
Japan
Facility Name
Local institution
City
Osaka
ZIP/Postal Code
545-8585
Country
Japan
Facility Name
Local Institution
City
Osaki
ZIP/Postal Code
989-6183
Country
Japan
Facility Name
Local institution
City
Oume
ZIP/Postal Code
198-0042
Country
Japan
Facility Name
Local institution
City
Sapporo
ZIP/Postal Code
001-0907
Country
Japan
Facility Name
Local Institution
City
Sapporo
ZIP/Postal Code
060-0001
Country
Japan
Facility Name
Local Institution
City
Sapporo
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Local Institution
City
Sapporo
ZIP/Postal Code
063-0811
Country
Japan
Facility Name
Local Institution
City
Sasebo
ZIP/Postal Code
857-1195
Country
Japan
Facility Name
Local Institution
City
Sayama
ZIP/Postal Code
350-1305
Country
Japan
Facility Name
Local Institution
City
Sendai
ZIP/Postal Code
980-6116
Country
Japan
Facility Name
Local Institution
City
Sendai
ZIP/Postal Code
982-0032
Country
Japan
Facility Name
Local Institution
City
Sendai
ZIP/Postal Code
983-8512
Country
Japan
Facility Name
Local Institution
City
Shizuoka
ZIP/Postal Code
420-0821
Country
Japan
Facility Name
Local Institution
City
Takaoka
ZIP/Postal Code
933-0874
Country
Japan
Facility Name
Local Institution
City
Takasaki
ZIP/Postal Code
370-0053
Country
Japan
Facility Name
Local institution
City
Tokyo
ZIP/Postal Code
101-0062
Country
Japan
Facility Name
Local Institution
City
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Local Institution
City
Tokyo
ZIP/Postal Code
130-8575
Country
Japan
Facility Name
Local Institution
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Local Institution
City
Tokyo
ZIP/Postal Code
162-8543
Country
Japan
Facility Name
Local Institution
City
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Local Institution
City
Tokyo
ZIP/Postal Code
170-8476
Country
Japan
Facility Name
Local Institution
City
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
Local Institution
City
Tokyo
ZIP/Postal Code
174-0071
Country
Japan
Facility Name
Local Institution
City
Tokyo
ZIP/Postal Code
179-0072
Country
Japan
Facility Name
Local Institution
City
Tomakomai
ZIP/Postal Code
053-0018
Country
Japan
Facility Name
Local Institution
City
Toyama
ZIP/Postal Code
930-0138
Country
Japan
Facility Name
Local Institution
City
Toyama
ZIP/Postal Code
930-0194
Country
Japan
Facility Name
Local Institution
City
Utsunomiya
ZIP/Postal Code
321-0964
Country
Japan
Facility Name
Local institution
City
Yokohama
ZIP/Postal Code
231-8682
Country
Japan
Facility Name
Local institution
City
Yokohama
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Local Institution
City
Yotsukaido
ZIP/Postal Code
284-0003
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
Learn more about this trial
Abatacept Post-marketing Clinical Study in Japan
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