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)

Last updated: August 30, 2021
Sponsor: AbbVie
Overall Status: Completed

Phase

3

Condition

Rheumatoid Arthritis

Musculoskeletal Diseases

Collagen Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT02955212
M15-557
  • Ages > 18
  • All Genders

Study 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.

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.
  1. Participants must have failed (lack of efficacy) at least one of the following:methotrexate (MTX), sulfasalazine, or leflunomide.
  2. The following csDMARDs are allowed: oral or parenteral MTX, sulfasalazine,hydroxychloroquine, chloroquine, and leflunomide.
  3. 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:
  1. ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68joint counts) at Screening and Baseline Visits; and
  2. 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:
  1. Participants with limited exposure to bDMARD (< 3 months) OR
  2. 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

Total Participants: 338
Study Start date:
January 03, 2018
Estimated Completion Date:
September 03, 2020

Study 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.

Connect with a study center

  • Santa Casa de Belo Horizonte /ID# 153506

    Belo Horizonte, Minas Gerais 30150-221
    Brazil

    Site Not Available

  • Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 152964

    Curitiba, Parana 80030-110
    Brazil

    Site Not Available

  • Parana Medical Research Center /ID# 153507

    Maringa, Parana 87015-000
    Brazil

    Site Not Available

  • LMK Sevicos Medicos S/S /ID# 152963

    Porto Alegre, Rio Grande Do Sul 90480-000
    Brazil

    Site Not Available

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 152961

    Sao Jose Do Rio Preto, Sao Paulo 15090-000
    Brazil

    Site Not Available

  • CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 152966

    São Paulo, Sao Paulo 04266-010
    Brazil

    Site Not Available

  • CEPIC - Cent Paulista de Inv

    Sao Paulo, 04265-000
    Brazil

    Site Not Available

  • 1st Aff Hosp of Bengbu Med Col /ID# 162161

    Bengbu, Anhui 233099
    China

    Site Not Available

  • Anhui Provincial Hospital /ID# 161117

    Hefei, Anhui 230001
    China

    Site Not Available

  • Zhongshan Hosp. of Fudan Uni. /ID# 161108

    Shanghai, Anhui 200032
    China

    Site Not Available

  • The 1st Aff Hosp Xiamen Univ /ID# 162154

    Xiamen, Fujian 361003
    China

    Site Not Available

  • Zhuzhou Central Hospital /ID# 162153

    Zhuzhou, Hunan 412007
    China

    Site Not Available

  • The First Affiliated Hospital /ID# 163747

    Baotou, Inner Mongolia 014016
    China

    Site Not Available

  • The First People's Hospital /ID# 168462

    Changzhou, Jiangsu 213004
    China

    Site Not Available

  • The First People's Hospital of Jiujiang /ID# 168461

    Jiujiang, Jiangxi 332000
    China

    Site Not Available

  • The First Hosp of Jilin Univ /ID# 161116

    Changchun, Jilin 130021
    China

    Site Not Available

  • Jining No.1 People's Hospital /ID# 162158

    Jining, Shandong 272001
    China

    Site Not Available

  • Shanghai Changhai Hospital /ID# 161123

    Shanghai, Shanghai 200433
    China

    Site Not Available

  • West China Hospital /ID# 161119

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • The First Affiliated Hospital of BaoTou Medical College /ID# 163747

    Baotou, Inner Mongolia, 014010
    China

    Site Not Available

  • Peking Union Med College Hosp /ID# 161107

    Beijing, 100730
    China

    Site Not Available

  • Xuanwu Hosp Capital Med Univ /ID# 161118

    Beijing, 100053
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University /ID# 162152

    Changsha, 410000
    China

    Site Not Available

  • West China Hospital, Sichuan University /ID# 161119

    Chendgu, 610041
    China

    Site Not Available

  • First Affiliated Hospital of Kunming Medical University /ID# 164637

    Kunming, 650032
    China

    Site Not Available

  • The First Affiliated Hospital of Kunming Medical Univesity /ID# 164637

    Kunming City, 650032
    China

    Site Not Available

  • Jiangsu Province Hospital /ID# 161122

    Nanjing, 210029
    China

    Site Not Available

  • Pingxiang People's Hospital /ID# 162151

    Pingxiang, 337055
    China

    Site Not Available

  • Pingxiang People's Hospital /ID# 162151

    Pingxiang City, 337055
    China

    Site Not Available

  • 1st Aff Hosp of Shantou Univ /ID# 162165

    Shantou Guangdong, 515041
    China

    Site Not Available

  • 1st Aff Hosp of Shantou Univ /ID# 162165

    Shantou, Guangdong, 515041
    China

    Site Not Available

  • The First Affiliated Hospital of Shantou University Medical /ID# 162165

    Shantou, Guangdong Province, 515041
    China

    Site Not Available

  • The Second Hospital of Shanxi /ID# 162164

    Taiyuan, 030001
    China

    Site Not Available

  • The Second Hospital of Shanxi Medical University /ID# 162164

    Taiyuan City, 030001
    China

    Site Not Available

  • Tianjin Med Univ General Hosp /ID# 162155

    Tianjin, 300052
    China

    Site Not Available

  • People's Hospital of Xinjiang /ID# 162157

    Urumqi, 830001
    China

    Site Not Available

  • First Affiliated Hospital of Xi'an Jiaotong University /ID# 162150

    Xi'an, 710061
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University /ID# 162150

    Xi'an City , Shaanxi Provinc, 710061
    China

    Site Not Available

  • Zhuzhou Central Hospital /ID# 162153

    Zhuzhou City, 412007
    China

    Site Not Available

  • SoonChunHyang University CheonAn Hospital /ID# 209078

    Cheonan-si, Chungcheongnamdo 31151
    Korea, Republic of

    Site Not Available

  • Kyungpook National Univ Hosp /ID# 166919

    Daegu, Daegu Gwang Yeogsi 41944
    Korea, Republic of

    Site Not Available

  • Chungnam National University Hospital /ID# 167727

    Jung-gu, Daejeon Gwang Yeogsi 35015
    Korea, Republic of

    Site Not Available

  • St. Vincent's Hospital /ID# 166918

    Suwon, Gyeonggido 16247
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital /ID# 163912

    Suwon-si, Gyeonggido 16499
    Korea, Republic of

    Site Not Available

  • Inha University Hospital /ID# 163910

    Jung-gu, Incheon Gwang Yeogsi 22332
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hospital /ID# 167726

    Gwangju, Jeonranamdo 61469
    Korea, Republic of

    Site Not Available

  • Kyung Hee University Medical Center /ID# 163908

    Dongdaemun-gu, Seoul Teugbyeolsi 02447
    Korea, Republic of

    Site Not Available

  • SMG-SNU Boramae Medical Center /ID# 163911

    Dongjak-gu, Seoul Teugbyeolsi 07061
    Korea, Republic of

    Site Not Available

  • Yonsei University Health System, Severance Hospital /ID# 168421

    Seodaemun-gu, Seoul Teugbyeolsi 03722
    Korea, Republic of

    Site Not Available

  • Yonsei University Health Syste

    Seodaemungu, Seoul Teugbyeolsi 03722
    Korea, Republic of

    Site Not Available

  • Hanyang University Seoul Hospi /ID# 163913

    Seongdong-gu, Seoul Teugbyeolsi 04763
    Korea, Republic of

    Site Not Available

  • Konkuk University Medical Ctr /ID# 206148

    Seoul, Seoul Teugbyeolsi 05030
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Yeouido St. Mary's Hospital /ID# 204224

    Seoul, Seoul Teugbyeolsi 07345
    Korea, Republic of

    Site Not Available

  • Inha University Hospital

    Incheon, 400-711
    Korea, Republic of

    Site Not Available

  • Asan Medical Center /ID# 163909

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Chung-Ang University Hostipal /ID# 209076

    Seoul, 06973
    Korea, Republic of

    Site Not Available

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