Phase
Condition
Rheumatoid Arthritis
Musculoskeletal Diseases
Collagen Vascular Diseases
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosis of RA for ≥ 3 months who also fulfill the 2010 American College ofRheumatology (ACR)/ European League Against Rheumatism (EULAR) classification criteriafor 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 combinationof 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 68joint 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-modifyinganti-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 tointolerability (regardless of treatment duration).
- Participants must have discontinued bDMARD therapy prior to the first dose of studydrug.
Exclusion
Exclusion Criteria:
- Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited totofacitinib, baricitinib, and filgotinib).
- Participants who are considered inadequate responders (lack of efficacy) to bDMARDtherapy as defined by the Investigator.
- History of any arthritis with onset prior to age 17 years or current diagnosis ofinflammatory joint disease other than RA (including but not limited to gout, systemiclupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosingspondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlapconnective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia [currently with active symptoms]. Current diagnosis of secondary Sjogren's Syndrome ispermitted.
Study Design
Study Description
Connect with a study center
Santa Casa de Belo Horizonte /ID# 153506
Belo Horizonte, Minas Gerais 30150-221
BrazilSite Not Available
Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 152964
Curitiba, Parana 80030-110
BrazilSite Not Available
Parana Medical Research Center /ID# 153507
Maringa, Parana 87015-000
BrazilSite Not Available
LMK Sevicos Medicos S/S /ID# 152963
Porto Alegre, Rio Grande Do Sul 90480-000
BrazilSite Not Available
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 152961
Sao Jose Do Rio Preto, Sao Paulo 15090-000
BrazilSite Not Available
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 152966
São Paulo, Sao Paulo 04266-010
BrazilSite Not Available
CEPIC - Cent Paulista de Inv
Sao Paulo, 04265-000
BrazilSite Not Available
1st Aff Hosp of Bengbu Med Col /ID# 162161
Bengbu, Anhui 233099
ChinaSite Not Available
Anhui Provincial Hospital /ID# 161117
Hefei, Anhui 230001
ChinaSite Not Available
Zhongshan Hosp. of Fudan Uni. /ID# 161108
Shanghai, Anhui 200032
ChinaSite Not Available
The 1st Aff Hosp Xiamen Univ /ID# 162154
Xiamen, Fujian 361003
ChinaSite Not Available
Zhuzhou Central Hospital /ID# 162153
Zhuzhou, Hunan 412007
ChinaSite Not Available
The First Affiliated Hospital /ID# 163747
Baotou, Inner Mongolia 014016
ChinaSite Not Available
The First People's Hospital /ID# 168462
Changzhou, Jiangsu 213004
ChinaSite Not Available
The First People's Hospital of Jiujiang /ID# 168461
Jiujiang, Jiangxi 332000
ChinaSite Not Available
The First Hosp of Jilin Univ /ID# 161116
Changchun, Jilin 130021
ChinaSite Not Available
Jining No.1 People's Hospital /ID# 162158
Jining, Shandong 272001
ChinaSite Not Available
Shanghai Changhai Hospital /ID# 161123
Shanghai, Shanghai 200433
ChinaSite Not Available
West China Hospital /ID# 161119
Chengdu, Sichuan 610041
ChinaSite Not Available
The First Affiliated Hospital of BaoTou Medical College /ID# 163747
Baotou, Inner Mongolia, 014010
ChinaSite Not Available
Peking Union Med College Hosp /ID# 161107
Beijing, 100730
ChinaSite Not Available
Xuanwu Hosp Capital Med Univ /ID# 161118
Beijing, 100053
ChinaSite Not Available
The Second Xiangya Hospital of Central South University /ID# 162152
Changsha, 410000
ChinaSite Not Available
West China Hospital, Sichuan University /ID# 161119
Chendgu, 610041
ChinaSite Not Available
First Affiliated Hospital of Kunming Medical University /ID# 164637
Kunming, 650032
ChinaSite Not Available
The First Affiliated Hospital of Kunming Medical Univesity /ID# 164637
Kunming City, 650032
ChinaSite Not Available
Jiangsu Province Hospital /ID# 161122
Nanjing, 210029
ChinaSite Not Available
Pingxiang People's Hospital /ID# 162151
Pingxiang, 337055
ChinaSite Not Available
Pingxiang People's Hospital /ID# 162151
Pingxiang City, 337055
ChinaSite Not Available
1st Aff Hosp of Shantou Univ /ID# 162165
Shantou Guangdong, 515041
ChinaSite Not Available
1st Aff Hosp of Shantou Univ /ID# 162165
Shantou, Guangdong, 515041
ChinaSite Not Available
The First Affiliated Hospital of Shantou University Medical /ID# 162165
Shantou, Guangdong Province, 515041
ChinaSite Not Available
The Second Hospital of Shanxi /ID# 162164
Taiyuan, 030001
ChinaSite Not Available
The Second Hospital of Shanxi Medical University /ID# 162164
Taiyuan City, 030001
ChinaSite Not Available
Tianjin Med Univ General Hosp /ID# 162155
Tianjin, 300052
ChinaSite Not Available
People's Hospital of Xinjiang /ID# 162157
Urumqi, 830001
ChinaSite Not Available
First Affiliated Hospital of Xi'an Jiaotong University /ID# 162150
Xi'an, 710061
ChinaSite Not Available
The First Affiliated Hospital of Xi'an Jiaotong University /ID# 162150
Xi'an City , Shaanxi Provinc, 710061
ChinaSite Not Available
Zhuzhou Central Hospital /ID# 162153
Zhuzhou City, 412007
ChinaSite Not Available
SoonChunHyang University CheonAn Hospital /ID# 209078
Cheonan-si, Chungcheongnamdo 31151
Korea, Republic ofSite Not Available
Kyungpook National Univ Hosp /ID# 166919
Daegu, Daegu Gwang Yeogsi 41944
Korea, Republic ofSite Not Available
Chungnam National University Hospital /ID# 167727
Jung-gu, Daejeon Gwang Yeogsi 35015
Korea, Republic ofSite Not Available
St. Vincent's Hospital /ID# 166918
Suwon, Gyeonggido 16247
Korea, Republic ofSite Not Available
Ajou University Hospital /ID# 163912
Suwon-si, Gyeonggido 16499
Korea, Republic ofSite Not Available
Inha University Hospital /ID# 163910
Jung-gu, Incheon Gwang Yeogsi 22332
Korea, Republic ofSite Not Available
Chonnam National University Hospital /ID# 167726
Gwangju, Jeonranamdo 61469
Korea, Republic ofSite Not Available
Kyung Hee University Medical Center /ID# 163908
Dongdaemun-gu, Seoul Teugbyeolsi 02447
Korea, Republic ofSite Not Available
SMG-SNU Boramae Medical Center /ID# 163911
Dongjak-gu, Seoul Teugbyeolsi 07061
Korea, Republic ofSite Not Available
Yonsei University Health System, Severance Hospital /ID# 168421
Seodaemun-gu, Seoul Teugbyeolsi 03722
Korea, Republic ofSite Not Available
Yonsei University Health Syste
Seodaemungu, Seoul Teugbyeolsi 03722
Korea, Republic ofSite Not Available
Hanyang University Seoul Hospi /ID# 163913
Seongdong-gu, Seoul Teugbyeolsi 04763
Korea, Republic ofSite Not Available
Konkuk University Medical Ctr /ID# 206148
Seoul, Seoul Teugbyeolsi 05030
Korea, Republic ofSite Not Available
The Catholic University of Korea, Yeouido St. Mary's Hospital /ID# 204224
Seoul, Seoul Teugbyeolsi 07345
Korea, Republic ofSite Not Available
Inha University Hospital
Incheon, 400-711
Korea, Republic ofSite Not Available
Asan Medical Center /ID# 163909
Seoul, 05505
Korea, Republic ofSite Not Available
Chung-Ang University Hostipal /ID# 209076
Seoul, 06973
Korea, Republic ofSite Not Available
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