Back to resultsA Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs)
Primary Purpose
Rheumatoid Arthritis (RA)
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Upadacitinib
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis (RA) focused on measuring Rheumatoid Arthritis, Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs), ABT-494
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of RA for ≥ 3 months who also fulfill the 2010 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) classification criteria for RA.
Participants have been receiving csDMARD therapy ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug.
- Participants must have failed (lack of efficacy) at least one of the following: methotrexate (MTX), sulfasalazine, or leflunomide.
- The following csDMARDs are allowed: oral or parenteral MTX, sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide.
- A combination of up to two background csDMARDs is allowed except the combination of MTX and leflunomide.
Participant meets both of the following disease activity criteria:
- ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits; and
- High-sensitivity C-Reactive Protein (hsCRP) ≥ 3 mg/L at Screening
Participants with prior exposure to at most one biological disease-modifying anti-rheumatic drugs (bDMARD) may be enrolled (up to 20% of total number of subjects). Specifically, prior to enrollment:
- Participants with limited exposure to bDMARD (< 3 months) OR
- Participants who are responding to a bDMARD therapy but had to discontinue due to intolerability (regardless of treatment duration).
- Participants must have discontinued bDMARD therapy prior to the first dose of study drug.
Exclusion Criteria:
- Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
- Participants who are considered inadequate responders (lack of efficacy) to bDMARD therapy as defined by the Investigator.
- History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia [currently with active symptoms]. Current diagnosis of secondary Sjogren's Syndrome is permitted.
Sites / Locations
- Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 152964
- Parana Medical Research Center /ID# 153507
- LMK Sevicos Medicos S/S /ID# 152963
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 152961
- CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 152966
- 1st Aff Hosp of Bengbu Med Col /ID# 162161
- Anhui Provincial Hospital /ID# 161117
- Zhongshan Hosp. of Fudan Uni. /ID# 161108
- The 1st Aff Hosp Xiamen Univ /ID# 162154
- Zhuzhou Central Hospital /ID# 162153
- The First Affiliated Hospital /ID# 163747
- The First People's Hospital /ID# 168462
- The First People's Hospital of Jiujiang /ID# 168461
- The First Hosp of Jilin Univ /ID# 161116
- Jining No.1 People's Hospital /ID# 162158
- Shanghai Changhai Hospital /ID# 161123
- West China Hospital /ID# 161119
- Xuanwu Hosp Capital Med Univ /ID# 161118
- Peking Union Med College Hosp /ID# 161107
- The Second Xiangya Hospital of Central South University /ID# 162152
- First Affiliated Hospital of Kunming Medical University /ID# 164637
- Jiangsu Province Hospital /ID# 161122
- Pingxiang People's Hospital /ID# 162151
- 1st Aff Hosp of Shantou Univ /ID# 162165
- The Second Hospital of Shanxi /ID# 162164
- Tianjin Med Univ General Hosp /ID# 162155
- People's Hospital of Xinjiang /ID# 162157
- First Affiliated Hospital of Xi'an Jiaotong University /ID# 162150
- SoonChunHyang University CheonAn Hospital /ID# 209078
- Kyungpook National Univ Hosp /ID# 166919
- Chungnam National University Hospital /ID# 167727
- Ajou University Hospital /ID# 163912
- St. Vincent's Hospital /ID# 166918
- Inha University Hospital /ID# 163910
- Chonnam National University Hospital /ID# 167726
- Kyung Hee University Medical Center /ID# 163908
- SMG-SNU Boramae Medical Center /ID# 163911
- Yonsei University Health System, Severance Hospital /ID# 168421
- Hanyang University Seoul Hospi /ID# 163913
- Konkuk University Medical Ctr /ID# 206148
- The Catholic University of Korea, Yeouido St. Mary's Hospital /ID# 204224
- Asan Medical Center /ID# 163909
- Chung-Ang University Hostipal /ID# 209076
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo / Upadacitinib 15 mg
Upadacitinib 15 mg
Arm Description
Participants randomized to receive placebo once daily for 12 weeks in Period 1 followed by upadacitinib 15 mg once daily for up to 52 weeks in Period 2.
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1 and up to an additional 52 weeks in Period 2.
Outcomes
Primary Outcome Measures
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
≥ 20% improvement in 68-tender joint count;
≥ 20% improvement in 66-swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Secondary Outcome Measures
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) at Week 12
The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
A negative change from Baseline in the overall score indicates improvement.
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).
The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12
Low disease activity based on DAS28 (CRP) is defined a DAS28 (CRP) score of ≤ 3.2.
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to 10, where higher scores indicate more disease activity. A DAS28 score less than or equal to 3.2 indicates low disease activity.
Percentage of Participants Achieving Clinical Remission Based on DAS28 (CRP) at Week 12
Clinical remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) score of less than 2.6.
DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to 10, where higher scores indicate more disease activity.
Percentage of Participants Achieving Low Disease Activity Based on Clinical Disease Activity Index (CDAI) at Week 12
Low disease activity based on CDAI is defined as a CDAI score ≤ 10. CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity.
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
≥ 50% improvement in 68-tender joint count;
≥ 50% improvement in 66-swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:
≥ 70% improvement in 68-tender joint count;
≥ 70% improvement in 66-swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
≥ 20% improvement in 68-tender joint count;
≥ 20% improvement in 66-swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02955212
Brief Title
A Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs)
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
August 14, 2019 (Actual)
Study Completion Date
September 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study objectives of Period 1 of this study were to compare the efficacy, safety, and tolerability of upadacitinib versus placebo for the treatment of signs and symptoms of subjects from China and selected countries including Brazil and South Korea with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and have an inadequate response to csDMARDs.
The study objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib in subjects with RA who have completed Period 1.
Detailed Description
This is a Phase 3 multicenter study that includes two periods. Period 1 is a 12-week, randomized, double-blind, parallel-group, placebo-controlled period designed to compare the safety and efficacy of upadacitinib versus placebo for the treatment of signs and symptoms of participants with moderately to severely active RA who are on a stable dose of csDMARDs and have an inadequate response to csDMARDs. Period 2 is an open label 52 week extension period to evaluate the long-term safety, tolerability, and efficacy of upadacitinib in participants with RA who have completed Period 1.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis (RA)
Keywords
Rheumatoid Arthritis, Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs), ABT-494
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
338 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo / Upadacitinib 15 mg
Arm Type
Placebo Comparator
Arm Description
Participants randomized to receive placebo once daily for 12 weeks in Period 1 followed by upadacitinib 15 mg once daily for up to 52 weeks in Period 2.
Arm Title
Upadacitinib 15 mg
Arm Type
Experimental
Arm Description
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1 and up to an additional 52 weeks in Period 2.
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
ABT-494, RINVOQ™
Intervention Description
Tablets for oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets for oral administration
Primary Outcome Measure Information:
Title
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
Description
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
≥ 20% improvement in 68-tender joint count;
≥ 20% improvement in 66-swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) at Week 12
Description
The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
Description
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
A negative change from Baseline in the overall score indicates improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
Description
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).
The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
Time Frame
Baseline and Week 12
Title
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12
Description
Low disease activity based on DAS28 (CRP) is defined a DAS28 (CRP) score of ≤ 3.2.
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to 10, where higher scores indicate more disease activity. A DAS28 score less than or equal to 3.2 indicates low disease activity.
Time Frame
Week 12
Title
Percentage of Participants Achieving Clinical Remission Based on DAS28 (CRP) at Week 12
Description
Clinical remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) score of less than 2.6.
DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to 10, where higher scores indicate more disease activity.
Time Frame
Week 12
Title
Percentage of Participants Achieving Low Disease Activity Based on Clinical Disease Activity Index (CDAI) at Week 12
Description
Low disease activity based on CDAI is defined as a CDAI score ≤ 10. CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity.
Time Frame
Week 12
Title
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
Description
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
≥ 50% improvement in 68-tender joint count;
≥ 50% improvement in 66-swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Time Frame
Baseline and Week 12
Title
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
Description
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:
≥ 70% improvement in 68-tender joint count;
≥ 70% improvement in 66-swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Time Frame
Baseline and Week 12
Title
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1
Description
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
≥ 20% improvement in 68-tender joint count;
≥ 20% improvement in 66-swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Time Frame
Baseline and Week 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of RA for ≥ 3 months who also fulfill the 2010 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) classification criteria for RA.
Participants have been receiving csDMARD therapy ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug.
Participants must have failed (lack of efficacy) at least one of the following: methotrexate (MTX), sulfasalazine, or leflunomide.
The following csDMARDs are allowed: oral or parenteral MTX, sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide.
A combination of up to two background csDMARDs is allowed except the combination of MTX and leflunomide.
Participant meets both of the following disease activity criteria:
≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits; and
High-sensitivity C-Reactive Protein (hsCRP) ≥ 3 mg/L at Screening
Participants with prior exposure to at most one biological disease-modifying anti-rheumatic drugs (bDMARD) may be enrolled (up to 20% of total number of subjects). Specifically, prior to enrollment:
Participants with limited exposure to bDMARD (< 3 months) OR
Participants who are responding to a bDMARD therapy but had to discontinue due to intolerability (regardless of treatment duration).
Participants must have discontinued bDMARD therapy prior to the first dose of study drug.
Exclusion Criteria:
Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
Participants who are considered inadequate responders (lack of efficacy) to bDMARD therapy as defined by the Investigator.
History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia [currently with active symptoms]. Current diagnosis of secondary Sjogren's Syndrome is permitted.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 152964
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80030-110
Country
Brazil
Facility Name
Parana Medical Research Center /ID# 153507
City
Maringa
State/Province
Parana
ZIP/Postal Code
87015-000
Country
Brazil
Facility Name
LMK Sevicos Medicos S/S /ID# 152963
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90480-000
Country
Brazil
Facility Name
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 152961
City
Sao Jose Do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 152966
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04266-010
Country
Brazil
Facility Name
1st Aff Hosp of Bengbu Med Col /ID# 162161
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233099
Country
China
Facility Name
Anhui Provincial Hospital /ID# 161117
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
Zhongshan Hosp. of Fudan Uni. /ID# 161108
City
Shanghai
State/Province
Anhui
ZIP/Postal Code
200032
Country
China
Facility Name
The 1st Aff Hosp Xiamen Univ /ID# 162154
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Facility Name
Zhuzhou Central Hospital /ID# 162153
City
Zhuzhou
State/Province
Hunan
ZIP/Postal Code
412007
Country
China
Facility Name
The First Affiliated Hospital /ID# 163747
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014016
Country
China
Facility Name
The First People's Hospital /ID# 168462
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213004
Country
China
Facility Name
The First People's Hospital of Jiujiang /ID# 168461
City
Jiujiang
State/Province
Jiangxi
ZIP/Postal Code
332000
Country
China
Facility Name
The First Hosp of Jilin Univ /ID# 161116
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Jining No.1 People's Hospital /ID# 162158
City
Jining
State/Province
Shandong
ZIP/Postal Code
272001
Country
China
Facility Name
Shanghai Changhai Hospital /ID# 161123
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
West China Hospital /ID# 161119
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Xuanwu Hosp Capital Med Univ /ID# 161118
City
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Peking Union Med College Hosp /ID# 161107
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
The Second Xiangya Hospital of Central South University /ID# 162152
City
Changsha
ZIP/Postal Code
410000
Country
China
Facility Name
First Affiliated Hospital of Kunming Medical University /ID# 164637
City
Kunming
ZIP/Postal Code
650032
Country
China
Facility Name
Jiangsu Province Hospital /ID# 161122
City
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
Pingxiang People's Hospital /ID# 162151
City
Pingxiang
ZIP/Postal Code
337055
Country
China
Facility Name
1st Aff Hosp of Shantou Univ /ID# 162165
City
Shantou Guangdong
ZIP/Postal Code
515041
Country
China
Facility Name
The Second Hospital of Shanxi /ID# 162164
City
Taiyuan
ZIP/Postal Code
030001
Country
China
Facility Name
Tianjin Med Univ General Hosp /ID# 162155
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
People's Hospital of Xinjiang /ID# 162157
City
Urumqi
ZIP/Postal Code
830001
Country
China
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University /ID# 162150
City
Xi'an
ZIP/Postal Code
710061
Country
China
Facility Name
SoonChunHyang University CheonAn Hospital /ID# 209078
City
Cheonan-si
State/Province
Chungcheongnamdo
ZIP/Postal Code
31151
Country
Korea, Republic of
Facility Name
Kyungpook National Univ Hosp /ID# 166919
City
Daegu
State/Province
Daegu Gwang Yeogsi
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital /ID# 167727
City
Jung-gu
State/Province
Daejeon Gwang Yeogsi
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Ajou University Hospital /ID# 163912
City
Suwon-si
State/Province
Gyeonggido
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
St. Vincent's Hospital /ID# 166918
City
Suwon
State/Province
Gyeonggido
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Inha University Hospital /ID# 163910
City
Jung-gu
State/Province
Incheon Gwang Yeogsi
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital /ID# 167726
City
Gwangju
State/Province
Jeonranamdo
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Kyung Hee University Medical Center /ID# 163908
City
Dongdaemun-gu
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center /ID# 163911
City
Dongjak-gu
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Yonsei University Health System, Severance Hospital /ID# 168421
City
Seodaemun-gu
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Hanyang University Seoul Hospi /ID# 163913
City
Seongdong-gu
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Konkuk University Medical Ctr /ID# 206148
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Yeouido St. Mary's Hospital /ID# 204224
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
07345
Country
Korea, Republic of
Facility Name
Asan Medical Center /ID# 163909
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Chung-Ang University Hostipal /ID# 209076
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Learn more about this trial
A Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs)
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