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)

NCT02955212 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: M15-557
• Study Type: interventional
• Target: 338
• Locations: 3 countries
• Sites: 43

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.

Conditions

Rheumatoid Arthritis (RA)

Keywords

Rheumatoid Arthritis; Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs); ABT-494

Outcome Measures

Primary Outcomes (1)

• 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: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 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).

  Baseline and Week 12

Secondary Outcomes (9)

• Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) at Week 12

  Baseline and Week 12

• Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12

  Baseline and Week 12

• Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12

  Baseline and Week 12

• Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12

  Week 12

• Percentage of Participants Achieving Clinical Remission Based on DAS28 (CRP) at Week 12

  Week 12

Study Arms (2)

Placebo / Upadacitinib 15 mg

PLACEBO COMPARATOR

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.

Drug: Upadacitinib; Drug: Placebo

Upadacitinib 15 mg

EXPERIMENTAL

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.

Drug: Upadacitinib

Interventions

Upadacitinib DRUG

Tablets for oral administration

Also known as: ABT-494, RINVOQ™

Placebo / Upadacitinib 15 mg; Upadacitinib 15 mg

Placebo DRUG

Tablets for oral administration

Placebo / Upadacitinib 15 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (43)

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

Curitiba, Paraná, 80030-110, Brazil

Location

Parana Medical Research Center /ID# 153507

Maringá, Paraná, 87015-000, Brazil

Location

LMK Sevicos Medicos S/S /ID# 152963

Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

Location

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

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

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

São Paulo, São Paulo, 04266-010, Brazil

Location

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

Bengbu, Anhui, 233099, China

Location

Anhui Provincial Hospital /ID# 161117

Hefei, Anhui, 230001, China

Location

Zhongshan Hosp. of Fudan Uni. /ID# 161108

Shanghai, Anhui, 200032, China

Location

The 1st Aff Hosp Xiamen Univ /ID# 162154

Xiamen, Fujian, 361003, China

Location

Zhuzhou Central Hospital /ID# 162153

Zhuzhou, Hunan, 412007, China

Location

The First Affiliated Hospital /ID# 163747

Baotou, Inner Mongolia, 014016, China

Location

The First People's Hospital /ID# 168462

Changzhou, Jiangsu, 213004, China

Location

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

Jiujiang, Jiangxi, 332000, China

Location

The First Hosp of Jilin Univ /ID# 161116

Changchun, Jilin, 130021, China

Location

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

Jining, Shandong, 272001, China

Location

Shanghai Changhai Hospital /ID# 161123

Shanghai, Shanghai Municipality, 200433, China

Location

West China Hospital /ID# 161119

Chengdu, Sichuan, 610041, China

Location

Xuanwu Hosp Capital Med Univ /ID# 161118

Beijing, 100053, China

Location

Peking Union Med College Hosp /ID# 161107

Beijing, 100730, China

Location

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

Changsha, 410000, China

Location

First Affiliated Hospital of Kunming Medical University /ID# 164637

Kunming, 650032, China

Location

Jiangsu Province Hospital /ID# 161122

Nanjing, 210029, China

Location

Pingxiang People's Hospital /ID# 162151

Pingxiang, 337055, China

Location

1st Aff Hosp of Shantou Univ /ID# 162165

Shantou Guangdong, 515041, China

Location

The Second Hospital of Shanxi /ID# 162164

Taiyuan, 030001, China

Location

Tianjin Med Univ General Hosp /ID# 162155

Tianjin, 300052, China

Location

People's Hospital of Xinjiang /ID# 162157

Ürümqi, 830001, China

Location

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

Xi'an, 710061, China

Location

SoonChunHyang University CheonAn Hospital /ID# 209078

Cheonan-si, Chungcheongnam-do, 31151, South Korea

Location

Kyungpook National Univ Hosp /ID# 166919

Daegu, Daegu Gwang Yeogsi, 41944, South Korea

Location

Chungnam National University Hospital /ID# 167727

Junggu, Daejeon Gwang Yeogsi, 35015, South Korea

Location

St. Vincent's Hospital /ID# 166918

Suwon, Gyeonggido, 16247, South Korea

Location

Ajou University Hospital /ID# 163912

Suwon, Gyeonggido, 16499, South Korea

Location

Inha University Hospital /ID# 163910

Junggu, Incheon Gwang Yeogsi, 22332, South Korea

Location

Chonnam National University Hospital /ID# 167726

Gwangju, Jeonranamdo, 61469, South Korea

Location

Kyung Hee University Medical Center /ID# 163908

Dongdaemun-gu, Seoul Teugbyeolsi, 02447, South Korea

Location

SMG-SNU Boramae Medical Center /ID# 163911

Dongjak-gu, Seoul Teugbyeolsi, 07061, South Korea

Location

Yonsei University Health System, Severance Hospital /ID# 168421

Seodaemun-gu, Seoul Teugbyeolsi, 03722, South Korea

Location

Hanyang University Seoul Hospi /ID# 163913

Seongdong-gu, Seoul Teugbyeolsi, 04763, South Korea

Location

Konkuk University Medical Ctr /ID# 206148

Seoul, Seoul Teugbyeolsi, 05030, South Korea

Location

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

Seoul, Seoul Teugbyeolsi, 07345, South Korea

Location

Asan Medical Center /ID# 163909

Seoul, 05505, South Korea

Location

Chung-Ang University Hostipal /ID# 209076

Seoul, 06973, South Korea

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 4, 2016
• Study Start: January 3, 2018
• Primary Completion: August 14, 2019
• Study Completion: September 3, 2020
• Last Updated: September 27, 2021
• Results First Posted: August 6, 2020

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• 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.

Locations

KR (15); BR (5); CN (23)