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Not recruiting
Phase 3

Upadacitinib vs. Adalimumab

Sponsor:

AbbVie

Code:

NCT05814627

Conditions

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Upadacitinib

Adalimumab

Upadacitinib Matching Placebo

Adalimumab Matching Placebo

Study Details

Brief summary:

Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will assess how safe and effective upadacitinib is in treating RA when compared to adalimumab in adult participants with inadequate response or intolerance to one TNF-inhibitor who are on a stable dose of methotrexate (MTX). Adverse events and change in disease activity will be assessed.

Upadacitinib is an approved drug for the treatment of RA. This study is double-blinded means that neither the participants nor the study doctors will know who will be given upadacitinib and who will be given adalimumab. Study doctors put the participants in 1 of the 2 groups, called treatment arms randomly, to receive either upadacitinib or adalimumab. There is 1 in 2 chance that participants will receive adalimumab. Each group consists of 2 periods. Approximately 480 participants diagnosed with RA will be enrolled in approximately 250 sites across the world.

Participants will receive the oral upadacitinib once daily and matching adalimumab placebo every other week, or the subcutaneous adalimumab every other week and matching upadacitinib placebo once daily during Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1 and will be followed for 30 days and 70 days.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Conditions

Rheumatoid Arthritis

Study ID

NCT05814627

Start date

Jun 15, 2023

Status verified date

May, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of Rheumatoid Arthritis (RA) for >= 3 months based on the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria for RA.
  • Treated for >= 3 consecutive months prior to screening with 1 tumor necrosis factor inhibitor (TNFi) (only 1 of originator or biosimilar certolizumab pegol, etanercept, golimumab or infliximab) for RA, but continue to exhibit active RA, or had to discontinue due to intolerability or toxicity, irrespective of treatment duration. Up to 15% of participants who were intolerant to 1 TNFi will be allowed to enroll. Prior administration of different biosimilar versions for the same originator TNFi or switching between originator and biosimilar version of the same originator TNFi are acceptable. Cycling between biosimilars of different originator TNF inhibitors is not acceptable.
  • On oral or parenteral methotrexate (MTX) therapy >= 3 consecutive months and on a stable prescription of 15 to 25 mg/week (or >= 10 mg/week in participants intolerant of MTX at doses >= 15 mg/week) for >= 4 weeks prior to the first dose of study drug. In addition, all participants should take a dietary supplement of folic acid or folinic acid throughout the study participation.

  • For a Chinese, Japanese, Korean, or Taiwanese participant, a stable dose of MTX >= 7.5 mg/week is acceptable.
  • Additional local requirements for MTX may apply.
  • Meets both of the following disease activity criteria:

  • >= 6 swollen joint (based on 66 joint counts) and >= 6 tender joints (based on 68 joint counts) at screening and baseline;
  • High-sensitivity C-reactive protein (hsCRP) >= 3 mg/L (central lab, upper limit of normal \[ULN\] 2.87 mg/L) at screening.

Exclusion Criteria:

  • History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than Rheumatoid Arthritis (RA).
  • Prior exposure to any janus kinase (JAK) inhibitor.
  • Prior exposure to adalimumab (original or biosimilar) or to any approved or investigational TNF inhibitor other than infliximab, etanercept, certolizumab pegol and golimumab.
  • Prior exposure to an approved or investigational non-TNFi biologic disease modifying anti-rheumatic drug (bDMARD) or targeted synthetic disease modifying antirheumatic drug (tsDMARD).

Study Design

Enrollment

480 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Upadacitinib+ Adalimumab matching Placebo

Participants will receive upadacitinib once a day along with matching placebo for adalimumab at eow (every other week) in Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1.

experimental: Adalimumab + Upadacitinib matching Placebo

Participants will receive adalimumab at eow (every other week) along with matching placebo for upadacitinib once a day in Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1.

Interventions

Upadacitinib

Oral Tablets

Adalimumab

Subcutaneous Injection

Upadacitinib Matching Placebo

Oral Tablets

Adalimumab Matching Placebo

Subcutaneous Injection

Primary outcome measure

  • Percentage of Participants Achieving Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) <= 3.2 [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 253431

Recruiting

Flagstaff, Arizona, United States, 86001-6299

Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 255018

Recruiting

Glendale, Arizona, United States, 85306-9802

Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 253432

Recruiting

Phoenix, Arizona, United States, 85032

Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 255021

Recruiting

Phoenix, Arizona, United States, 85032

Arizona Arthritis & Rheumatology Associates - Tucson /ID# 255017

Recruiting

Tucson, Arizona, United States, 85704

Arthritis and Rheumatism Associates /ID# 254013

Recruiting

Jonesboro, Arkansas, United States, 72401-6251

Contacts

Site Coordinator

870-333-2721

Providence - St. Jude Medical Center /ID# 252690

Recruiting

Fullerton, California, United States, 92835

Newport Huntington Medical Group /ID# 252687

Recruiting

Huntington Beach, California, United States, 92648-5994

Purushotham & Akther Kotha MD, Inc /ID# 252704

Recruiting

La Mesa, California, United States, 91942

Contacts

Site Coordinator

(619) 229-1995 x 208

Valerius Medical Group & Research Center of Greater Long Beach, Inc /ID# 252692

Recruiting

Los Alamitos, California, United States, 90720-5402

Rheumatology Center of San Diego /ID# 255038

Recruiting

San Diego, California, United States, 92128-2549

Millennium Clinical Trials /ID# 252689

Recruiting

Thousand Oaks, California, United States, 91360-3951

The Lundquist Institute at Harbor-UCLA Medical Center /ID# 252691

Recruiting

Torrance, California, United States, 90502

Comprehensive Rheumatology Center /ID# 252688

Recruiting

Woodland Hills, California, United States, 91364

University of Colorado Hospital /ID# 254617

Recruiting

Aurora, Colorado, United States, 80045

Tekton Research - Fort Collins - East Harmony Road /ID# 255036

Recruiting

Fort Collins, Colorado, United States, 80528

Arthritis and Rheumatic Disease Specialties /ID# 260583

Recruiting

Aventura, Florida, United States, 33180

Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253733

Recruiting

Boca Raton, Florida, United States, 33486

Bay Area Arthritis and Osteo /ID# 254046

Recruiting

Brandon, Florida, United States, 33511

Contacts

Site Coordinator

813-651-4441

Believe Clinical Trials /ID# 262355

Recruiting

Coral Springs, Florida, United States, 33065

International Medical Research /ID# 254651

Recruiting

Daytona Beach, Florida, United States, 32117

Omega Research Debary, LLC /ID# 253735

Recruiting

DeBary, Florida, United States, 32713-2260

Neoclinical Research /ID# 254622

Recruiting

Hialeah, Florida, United States, 33016-1897

Contacts

Site Coordinator

305-456-9062

Gnp Research - Hollywood /ID# 273563

Recruiting

Hollywood, Florida, United States, 33024

Life Clinical Trials /ID# 256061

Recruiting

Margate, Florida, United States, 33063

HMD Research LLC /ID# 253732

Recruiting

Orlando, Florida, United States, 32819

Millennium Research /ID# 253744

Recruiting

Ormond Beach, Florida, United States, 32174

Vitalia Research /ID# 274213

Recruiting

Palm Beach Gardens, Florida, United States, 33410

BayCare Medical Group /ID# 253799

Recruiting

Saint Petersburg, Florida, United States, 33705

Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 254649

Recruiting

Tampa, Florida, United States, 33606

Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 255264

Recruiting

Tampa, Florida, United States, 33606

Baycare Medical Group - Tampa /ID# 255268

Recruiting

Tampa, Florida, United States, 33614

Contacts

Site Coordinator

813-840-3600

Atlanta Research Center for Rheumatology /ID# 254623

Recruiting

Marietta, Georgia, United States, 20060

Next Innovative Clinical Research - Chicago /ID# 273453

Recruiting

Chicago, Illinois, United States, 60616

Deerbrook Medical Associates /ID# 254008

Recruiting

Libertyville, Illinois, United States, 60048

OrthoIllinois /ID# 254057

Recruiting

Rockford, Illinois, United States, 61114-4937

Greater Chicago Specialty Physicians /ID# 254000

Recruiting

Schaumburg, Illinois, United States, 60195-3106

Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 253999

Recruiting

Skokie, Illinois, United States, 60076

Willow Rheumatology and Wellness, PLLC /ID# 254712

Recruiting

Willowbrook, Illinois, United States, 60527

Western KY Rheumatology /ID# 255026

Recruiting

Hopkinsville, Kentucky, United States, 42240

Contacts

Site Coordinator

270-885-3876

Ochsner Clinic Foundation /ID# 254059

Recruiting

New Orleans, Louisiana, United States, 70121

AA Medical Research Center - Grand Blanc /ID# 254007

Recruiting

Grand Blanc, Michigan, United States, 48439

Contacts

Site Coordinator

810-694-0082

Advanced Rheumatology, PC /ID# 256059

Recruiting

Okemos, Michigan, United States, 48910

St. Paul Rheumatology, PA /ID# 255037

Recruiting

Eagan, Minnesota, United States, 55121

Kansas City Physician Partners /ID# 255035

Recruiting

Kansas City, Missouri, United States, 64151

Clinvest Research LLC /ID# 254054

Recruiting

Springfield, Missouri, United States, 65807

Logan Health Research /ID# 253738

Recruiting

Kalispell, Montana, United States, 59901

Physician Research Collaboration, LLC /ID# 254012

Recruiting

Lincoln, Nebraska, United States, 68516

Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 255266

Recruiting

Voorhees, New Jersey, United States, 08043

NYU Langone Ambulatory Care Brooklyn Heights /ID# 254621

Recruiting

Brooklyn, New York, United States, 11201

Joint And Muscle Research Institute /ID# 275128

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Site Coordinator

(704) 248-8577

Trinity Health Med Arts Clinic /ID# 254010

Recruiting

Minot, North Dakota, United States, 58701

Paramount Medical Research and Consulting /ID# 254048

Recruiting

Middleburg Heights, Ohio, United States, 44130

Contacts

Site Coordinator

440-826-0742

Rheumatology Associates of Oklahoma /ID# 253994

Recruiting

Oklahoma City, Oklahoma, United States, 73116-7226

Clinical Research of Philadelphia, LLC /ID# 255025

Recruiting

Philadelphia, Pennsylvania, United States, 19114

Contacts

Site Coordinator

212-676-6696

West Tennessee Research Institute /ID# 254620

Recruiting

Jackson, Tennessee, United States, 38305

Arthritis and Rheumatology Research Institute, PLLC /ID# 254045

Recruiting

Allen, Texas, United States, 75013-6147

Contacts

Site Coordinator

(972) 798-8553

Tekton Research, L.L.C /ID# 254004

Recruiting

Austin, Texas, United States, 78745

Contacts

Site Coordinator

512-388-5717

Trinity Universal Research Associates - Carrollton /ID# 254648

Recruiting

Carrollton, Texas, United States, 75007

Adriana Pop-Moody MD Clinic PA /ID# 255030

Recruiting

Corpus Christi, Texas, United States, 78404

Contacts

Site Coordinator

361-885-0010

JPS Rheumatology Clinic /ID# 254050

Recruiting

Fort Worth, Texas, United States, 76104-4917

Biopharma Informatic - Houston - Business Center Drive /ID# 254051

Recruiting

Houston, Texas, United States, 77043

Biopharma Informatic - Houston - Business Center Drive /ID# 254053

Recruiting

Houston, Texas, United States, 77043

Accurate Clinical Research - Houston /ID# 254647

Recruiting

Houston, Texas, United States, 77089-6142

R & H Clinical Research - 777 Katy /ID# 255024

Recruiting

Katy, Texas, United States, 77450-2244

West Texas Clinical Research /ID# 253736

Recruiting

Lubbock, Texas, United States, 79424

Contacts

Site Coordinator

8069931040

Trinity Universal Research Associates, Inc /ID# 253995

Recruiting

Plano, Texas, United States, 75024-5283

Sun Research Institute /ID# 255019

Recruiting

San Antonio, Texas, United States, 78215

Advanced Rheumatology of Houston /ID# 254003

Recruiting

The Woodlands, Texas, United States, 77382

Contacts

Site Coordinator

281-766-7886

DM Clinical Research - Tomball /ID# 254001

Recruiting

Tomball, Texas, United States, 77375

Rheumatology Clinic of Houston /ID# 254002

Recruiting

Tomball, Texas, United States, 77377

Contacts

Site Coordinator

2815170550

Rheumatic Disease Center, LLP /ID# 254015

Recruiting

Glendale, Wisconsin, United States, 53217

Manitoba Clinic /ID# 254019

Recruiting

Winnipeg, Manitoba, Canada, R3A 1M3

Centre Rhumatologie de l'Est /ID# 254932

Recruiting

Rimouski, Quebec, Canada, G5L 8W1

Groupe de Recherche en Maladies Osseuses Inc /ID# 253409

Recruiting

Sainte-foy, Quebec, Canada, G1V 3M7

Centre de Recherche Musculo-Squelettique /ID# 256273

Recruiting

Trois-rivières, Quebec, Canada, G8Z 1Y2

Dr. Latha Naik Medical Professional Corporation /ID# 254018

Recruiting

Saskatoon, Saskatchewan, Canada, S7H 0P4

More Information

Sponsor

AbbVie

Last update posted

May 31, 2025

Last verified

May, 2025

Keywords

  • Rheumatoid Arthritis
  • RA
  • Upadacitinib
  • Adalimumab
  • Methotrexate
  • MTX
  • TNF Inhibitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by AbbVie on 2025-05-31.