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)

NCT ID: NCT02955212

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 338 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-03
• Study Completion Date: 2020-09-03

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.

Conditions

Rheumatoid Arthritis (RA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo / Upadacitinib 15 mg

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.

Group Type: PLACEBO_COMPARATOR

Upadacitinib

Intervention Type: DRUG

Tablets for oral administration

Placebo

Intervention Type: DRUG

Tablets for oral administration

Upadacitinib 15 mg

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.

Group Type: EXPERIMENTAL

Upadacitinib

Intervention Type: DRUG

Tablets for oral administration

Interventions

Upadacitinib

Tablets for oral administration

Intervention Type: DRUG

Placebo

Tablets for oral administration

Intervention Type: DRUG

Other Intervention Names

ABT-494; RINVOQ™

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.

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 combination of 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 68 joint 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-modifying anti-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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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

Curitiba, Paraná, Brazil

Parana Medical Research Center /ID# 153507

Maringá, Paraná, Brazil

LMK Sevicos Medicos S/S /ID# 152963

Porto Alegre, Rio Grande do Sul, Brazil

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

São José do Rio Preto, São Paulo, Brazil

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

São Paulo, São Paulo, Brazil

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

Bengbu, Anhui, China

Anhui Provincial Hospital /ID# 161117

Hefei, Anhui, China

Zhongshan Hosp. of Fudan Uni. /ID# 161108

Shanghai, Anhui, China

The 1st Aff Hosp Xiamen Univ /ID# 162154

Xiamen, Fujian, China

Zhuzhou Central Hospital /ID# 162153

Zhuzhou, Hunan, China

The First Affiliated Hospital /ID# 163747

Baotou, Inner Mongolia, China

The First People's Hospital /ID# 168462

Changzhou, Jiangsu, China

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

Jiujiang, Jiangxi, China

The First Hosp of Jilin Univ /ID# 161116

Changchun, Jilin, China

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

Jining, Shandong, China

Shanghai Changhai Hospital /ID# 161123

Shanghai, Shanghai Municipality, China

West China Hospital /ID# 161119

Chengdu, Sichuan, China

Xuanwu Hosp Capital Med Univ /ID# 161118

Beijing, , China

Peking Union Med College Hosp /ID# 161107

Beijing, , China

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

Changsha, , China

First Affiliated Hospital of Kunming Medical University /ID# 164637

Kunming, , China

Jiangsu Province Hospital /ID# 161122

Nanjing, , China

Pingxiang People's Hospital /ID# 162151

Pingxiang, , China

1st Aff Hosp of Shantou Univ /ID# 162165

Shantou Guangdong, , China

The Second Hospital of Shanxi /ID# 162164

Taiyuan, , China

Tianjin Med Univ General Hosp /ID# 162155

Tianjin, , China

People's Hospital of Xinjiang /ID# 162157

Ürümqi, , China

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

Xi'an, , China

SoonChunHyang University CheonAn Hospital /ID# 209078

Cheonan-si, Chungcheongnam-do, South Korea

Kyungpook National Univ Hosp /ID# 166919

Daegu, Daegu Gwang Yeogsi, South Korea

Chungnam National University Hospital /ID# 167727

Junggu, Daejeon Gwang Yeogsi, South Korea

St. Vincent's Hospital /ID# 166918

Suwon, Gyeonggido, South Korea

Ajou University Hospital /ID# 163912

Suwon, Gyeonggido, South Korea

Inha University Hospital /ID# 163910

Junggu, Incheon Gwang Yeogsi, South Korea

Chonnam National University Hospital /ID# 167726

Gwangju, Jeonranamdo, South Korea

Kyung Hee University Medical Center /ID# 163908

Dongdaemun-gu, Seoul Teugbyeolsi, South Korea

SMG-SNU Boramae Medical Center /ID# 163911

Dongjak-gu, Seoul Teugbyeolsi, South Korea

Yonsei University Health System, Severance Hospital /ID# 168421

Seodaemun-gu, Seoul Teugbyeolsi, South Korea

Hanyang University Seoul Hospi /ID# 163913

Seongdong-gu, Seoul Teugbyeolsi, South Korea

Konkuk University Medical Ctr /ID# 206148

Seoul, Seoul Teugbyeolsi, South Korea

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

Seoul, Seoul Teugbyeolsi, South Korea

Asan Medical Center /ID# 163909

Seoul, , South Korea

Chung-Ang University Hostipal /ID# 209076

Seoul, , South Korea

Countries

Brazil; China; South Korea

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

M15-557

Identifier Type: -

Identifier Source: org_study_id