Rheumatoid Arthritis Clinical Trial
— SELECT- SWITCHOfficial title:
A Phase 3b/4 Randomized, Double-Blind, Double Dummy, Active Comparator-Controlled Study, Comparing the Efficacy and Safety of Upadacitinib Versus Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis on a Stable Background of MTX and Who Had an Inadequate Response or Intolerance to a Single TNF Inhibitor (SELECT- SWITCH)
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.
| Status | Recruiting |
| Enrollment | 480 |
| Est. completion date | August 15, 2026 |
| Est. primary completion date | September 23, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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). |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | ReumaClinic /ID# 252277 | Genk | |
| Belgium | UZ Gent /ID# 252306 | Gent | Oost-Vlaanderen |
| Belgium | CHU de Liege /ID# 252309 | Liege | |
| Brazil | CETI - Centro de Estudos em Terapias Inovadoras /ID# 254201 | Curitiba | Parana |
| Brazil | LMK Sevicos Medicos S/S /ID# 254202 | Porto Alegre | Rio Grande Do Sul |
| Brazil | Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 254917 | Sao Jose Do Rio Preto | Sao Paulo |
| Brazil | CEPIC - Centro Paulista de Investigacao Clinica /ID# 254200 | Sao Paulo | |
| Bulgaria | Medical center Unimed /ID# 252344 | Plovdiv | |
| Bulgaria | MHAT Plovdiv /ID# 252342 | Plovdiv | |
| Bulgaria | UMHAT Kaspela EOOD /ID# 252343 | Plovdiv | |
| Bulgaria | Diagnostic consultative center 17 Sofia /ID# 252341 | Sofia | |
| Bulgaria | Military Medical Academy Multiprofile Hospital /ID# 252355 | Sofia | |
| Bulgaria | Diagnostic consultative center Focus-5 /ID# 252354 | Sofiya | |
| Bulgaria | Diagnostic consultative center Focus-5 /ID# 252555 | Sofiya | |
| Canada | Centre Rhumatologie de l'Est /ID# 254932 | Rimouski | Quebec |
| Canada | Groupe de Recherche en Maladies Osseuses Inc /ID# 253409 | Sainte-foy | Quebec |
| Canada | Dr Naik-Medical Professional Corporation-Alliance Health /ID# 254018 | Saskatoon | Saskatchewan |
| Canada | Centre de Recherche Musculo-Squelettique /ID# 256273 | Trois-rivières | Quebec |
| Canada | Manitoba Clinic /ID# 254019 | Winnipeg | Manitoba |
| Chile | Corporacion de Beneficiencia Osorno /ID# 252556 | Osorno | Los Lagos |
| Chile | Centro Internacional de Estudios Clinicos - CIEC /ID# 252561 | Santiago | |
| Chile | Complejo Asistencial Dr. Sotero del Rio /ID# 252559 | Santiago | Region Metropolitana De Santiago |
| Chile | Clinica Dermacross /ID# 252560 | Vitacura | Region Metropolitana Santiago |
| China | Peking University First Hospital /ID# 252392 | Beijing | Beijing |
| China | Peking University Third Hospital /ID# 252393 | Beijing | Beijing |
| China | The first affiliated hospital of bengbu medical college /ID# 252612 | Bengbu | Anhui |
| China | West China Hospital, Sichuan University /ID# 252364 | Chengdu | Sichuan |
| China | The Third Affiliated Hospital, Sun Yat-Sen University /ID# 252394 | Guangzhou | Guangdong |
| China | Nanjing Drum Tower Hospital /ID# 252613 | Nanjing | Jiangsu |
| China | Jiangxi Pingxiang People's Hospital /ID# 252381 | Pingxiang | Jiangxi |
| China | Zhuzhou Central Hospital /ID# 252390 | Zhuzhou | Hunan |
| Colombia | Centro Integral de Reumatología del Caribe SAS - Circaribe SAS /ID# 252587 | Barranquilla | Atlantico |
| Colombia | Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 252586 | Bogotá | Cundinamarca |
| Colombia | Healthy Medical Center S.A.S /ID# 252585 | Zipaquirá | Cundinamarca |
| Croatia | Poliklinika Solmed /ID# 252453 | Grad Zagreb | |
| Croatia | Specijalna bolnica za medicinsku rehabilitaciju Krapinske Toplice /ID# 252455 | Krapinske Toplice | |
| Croatia | Medical Center Kuna-Peric /ID# 252452 | Zagreb | |
| Croatia | Poliklinika Bonifarm /ID# 252741 | Zagreb | |
| Croatia | Poliklinika Repromed /ID# 252451 | Zagreb | Grad Zagreb |
| France | CHU Amiens-Picardie Site Sud /ID# 252384 | Amiens CEDEX 1 | Somme |
| France | CHU Montpellier - Hôpital Lapeyronie /ID# 252386 | Montpellier | Herault |
| France | CHU Nice -Hopital Pasteur /ID# 254224 | Nice CEDEX 1 | Provence-Alpes-Cote-d Azur |
| France | Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 252385 | Orléans | |
| France | Hôpital Charles-Nicolle /ID# 252908 | Rouen | |
| France | CHU Toulouse - Hopital Purpan /ID# 252402 | TOULOUSE Cedex 9 | Haute-Garonne |
| Germany | Rheumazentrum Ruhrgebiet /ID# 252670 | Herne | |
| Germany | Klinische Forschung im med. Versorgungsalltag GbR /ID# 254221 | Planegg | |
| Germany | Rheumazentrum Ratingen /ID# 252669 | Ratingen | |
| Germany | Rheumatologische-Immunologische Praxis Templin /ID# 252863 | Templin | Brandenburg |
| Greece | General Hospital of Athens Laiko /ID# 252258 | Athens | Attiki |
| Greece | University General Hospital Attikon /ID# 254751 | Athens | Attiki |
| Greece | University General Hospital of Heraklion PA.G.N.I /ID# 252261 | Heraklion | Kriti |
| Hungary | Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 253311 | Budapest | |
| Hungary | CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 252400 | Szekesfehervar | |
| Hungary | MÁV Kórház /ID# 252628 | Szolnok | |
| Hungary | Vital Medicina Kft /ID# 252399 | Veszprém | Veszprem |
| Italy | Azienda Ospedaliero Universitaria Careggi /ID# 252460 | Florence | |
| Italy | ASST Gaetano Pini/Presidio Ospedaliero Pini /ID# 252461 | Milan | |
| Italy | Azienda Ospedaliero Universitaria Ospedali Riuniti Do Ancona /ID# 252459 | Torette | Ancona |
| Japan | Katayama Orthopedic Rheumatology Clinic /ID# 252746 | Asahikawa-shi | Hokkaido |
| Japan | St.Luke's International Hospital /ID# 253131 | Chuo-ku | Tokyo |
| Japan | Sugimoto Rheumatology and Internal Medicine Clinic /ID# 252774 | Fukui-shi | Fukui |
| Japan | Hamanomachi Hospital /ID# 253168 | Fukuoka-shi | Fukuoka |
| Japan | Shono Rheumatism Clinic /ID# 252591 | Fukuoka-shi | Fukuoka |
| Japan | Matsubara Mayflower Hospital /ID# 252834 | Kato-shi | Hyogo |
| Japan | Bay Side Misato Medical Center /ID# 252661 | Kochi-shi | Kochi |
| Japan | Kumamoto Orthopaedic Hospital /ID# 253167 | Kumamoto shi | Kumamoto |
| Japan | Medical Corporation Keiai Kai Clinic /ID# 252750 | Miyazaki-shi | Miyazaki |
| Japan | Daido Clinic /ID# 253058 | Nagoya-shi | Aichi |
| Japan | Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 252836 | Nagoya-shi | Aichi |
| Japan | Sanuki Municipal Hospital /ID# 252747 | Sanuki-shi | Kagawa |
| Japan | Sagawa Akira Rheumatology Clin /ID# 252773 | Sapporo-shi | Hokkaido |
| Japan | Sasebo Chuo Hospital /ID# 252662 | Sasebo-shi | Nagasaki |
| Japan | Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 253057 | Shimonoseki-shi | Yamaguchi |
| Japan | Keio University Hospital /ID# 253205 | Shinjuku-ku | Tokyo |
| Korea, Republic of | SoonChunHyang University Hospital Cheonan /ID# 254942 | Cheonan-si | Chungcheongnamdo |
| Korea, Republic of | Chungnam National University Hospital /ID# 252159 | Daejeon | Daejeon Gwang Yeogsi |
| Korea, Republic of | Chonnam National University Bitgoeul Hospital /ID# 254802 | Gwangju | Gwangju Gwang Yeogsi |
| Korea, Republic of | Hanyang University Seoul Hospital /ID# 252161 | Seoul | Seoul Teugbyeolsi |
| Korea, Republic of | Seoul National University Hospital /ID# 252160 | Seoul | |
| Mexico | Investigacion y Biomedicina de Chihuahua /ID# 253115 | Chihuahua | |
| Mexico | Centro Integral en Reumatologia S.A de C.V /ID# 252872 | Guadalajara | Jalisco |
| Mexico | Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 253480 | Guadalajara | Jalisco |
| Mexico | CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 252873 | Mexico City | Ciudad De Mexico |
| Mexico | Hospital de Jesus /ID# 253114 | Mexico City | Distrito Federal |
| Portugal | Hospital Garcia de Orta /ID# 252491 | Almada | Setubal |
| Portugal | Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 252492 | Lisboa | |
| Portugal | Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 252489 | Ponte de Lima | Viana Do Castelo |
| Puerto Rico | GCM Medical Group PSC /ID# 252700 | San Juan | |
| Puerto Rico | Mindful Medical Research /ID# 252693 | San Juan | |
| Romania | Spitalul Judetean de Urgenta Bacau /ID# 252860 | Bacau | |
| Romania | Spitalul Clinic Sf. Maria /ID# 252759 | Bucuresti | |
| Romania | Spitalul Clinic Sf. Maria /ID# 253334 | Bucuresti | |
| Romania | Banat Carina Med SRL /ID# 252757 | Timisoara | Timis |
| Romania | Cabinet Medical Dr. Avram S.R.L /ID# 254133 | Timisoara | Timis |
| Serbia | Institute for Rheumatology /ID# 252333 | Belgrade | Beograd |
| Serbia | Institute for Rheumatology /ID# 252334 | Belgrade | Beograd |
| Serbia | Institute for Rheumatology /ID# 252335 | Belgrade | Beograd |
| Serbia | Institute for Rheumatology /ID# 252338 | Belgrade | Beograd |
| Serbia | Special Hospital for Rheuma /ID# 252336 | Novi Sad | Vojvodina |
| Serbia | Special Hospital for Rheuma /ID# 252339 | Novi Sad | Vojvodina |
| South Africa | Arthritis Clinical Research Trials /ID# 252370 | Cape Town | Western Cape |
| South Africa | Winelands Medical Research - Somerset West /ID# 252745 | Cape Town | Western Cape |
| South Africa | Dr Elsa van Duuren /ID# 252387 | Pretoria | Gauteng |
| South Africa | Emmed Research cc /ID# 254317 | Pretoria | Gauteng |
| South Africa | University of Pretoria /ID# 252368 | Pretoria | Gauteng |
| South Africa | Winelands Medical Research Centre /ID# 252369 | Stellenbosch | Western Cape |
| South Africa | Dr Asokan Naidoo /ID# 252894 | Umhlanga | Kwazulu-Natal |
| Spain | Hospital Universitario Germans Trias i Pujol /ID# 254144 | Badalona | Barcelona |
| Spain | Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 252425 | Sabadell | Barcelona |
| Spain | Hospital Clínico Universitario de Santiago-CHUS /ID# 252430 | Santiago de Compostela | A Coruna |
| Spain | Hospital Universitario y Politecnico La Fe /ID# 254143 | Valencia | |
| Spain | Hospital Marina Baixa /ID# 254141 | Villajoyosa | Alicante |
| United Kingdom | The Queen Elizabeth Hospital, Kings Lynn NHS Foundation Trust /ID# 252301 | Kings Lynn | Norfolk |
| United Kingdom | Queen Mary University of London /ID# 252671 | London | |
| United Kingdom | Royal Free Hospital /ID# 252297 | London | London, City Of |
| United Kingdom | Portsmouth Hospitals University NHS Trust /ID# 252772 | Portsmouth | |
| United States | Arthritis and Rheumatology Research Institute, PLLC /ID# 254045 | Allen | Texas |
| United States | University of Colorado Hospital /ID# 254617 | Aurora | Colorado |
| United States | Tekton Research, Inc. /ID# 254004 | Austin | Texas |
| United States | Arthritis and Rheumatic Disease Specialties /ID# 260583 | Aventura | Florida |
| United States | Ochsner Clinic Foundation /ID# 254059 | Baton Rouge | Louisiana |
| United States | Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253733 | Boca Raton | Florida |
| United States | Beth Israel Deaconess Medical Center - Rheumatology /ID# 255029 | Boston | Massachusetts |
| United States | Bay Area Arthritis and Osteo /ID# 254046 | Brandon | Florida |
| United States | NYU Langone Ambulatory Care Brooklyn Heights /ID# 254621 | Brooklyn | New York |
| United States | Trinity Universal Research Associates - Carrollton /ID# 254648 | Carrollton | Texas |
| United States | Believe Clinical Trials /ID# 262355 | Coral Springs | Florida |
| United States | Adriana Pop-Moody MD Clinic PA /ID# 255030 | Corpus Christi | Texas |
| United States | International Medical Research /ID# 254651 | Daytona Beach | Florida |
| United States | Omega Research Debary, LLC /ID# 253735 | DeBary | Florida |
| United States | Denver Arthritis Clinic /ID# 254058 | Denver | Colorado |
| United States | St. Paul Rheumatology, PA /ID# 255037 | Eagan | Minnesota |
| United States | Qualmedica Research - Evansville /ID# 254005 | Evansville | Indiana |
| United States | AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 253431 | Flagstaff | Arizona |
| United States | Tekton Research /ID# 255036 | Fort Collins | Colorado |
| United States | JPS Rheumatology Clinic /ID# 254050 | Fort Worth | Texas |
| United States | Aurora Rheumatology and Immunotherapy Center /ID# 254049 | Franklin | Wisconsin |
| United States | Providence - St. Jude Medical Center /ID# 252690 | Fullerton | California |
| United States | Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 255018 | Glendale | Arizona |
| United States | Rheumatic Disease Center, LLP /ID# 254015 | Glendale | Wisconsin |
| United States | AA Medical Research Center - Grand Blanc /ID# 254007 | Grand Blanc | Michigan |
| United States | Arthritis Associates /ID# 253992 | Hattiesburg | Mississippi |
| United States | Neoclinical Research /ID# 254622 | Hialeah | Florida |
| United States | Hinsdale Orthopaedics /ID# 254712 | Hinsdale | Illinois |
| United States | Western KY Rheumatology /ID# 255026 | Hopkinsville | Kentucky |
| United States | Accurate Clinical Research /ID# 254647 | Houston | Texas |
| United States | Biopharma Informatic - Houston - Business Center Drive /ID# 254051 | Houston | Texas |
| United States | Biopharma Informatic - Houston - Business Center Drive /ID# 254053 | Houston | Texas |
| United States | Newport Huntington Medical Group /ID# 252687 | Huntington Beach | California |
| United States | West Tennessee Research Institute /ID# 254620 | Jackson | Tennessee |
| United States | Arthritis and Rheumatism Associates /ID# 254013 | Jonesboro | Arkansas |
| United States | Logan Health Research /ID# 253738 | Kalispell | Montana |
| United States | Kansas City Physician Partners /ID# 255035 | Kansas City | Missouri |
| United States | R & H Clinical Research - 777 Katy /ID# 255024 | Katy | Texas |
| United States | Purushotham & Akther Kotha MD, Inc /ID# 252704 | La Mesa | California |
| United States | Advanced Rheumatology, PC /ID# 256059 | Lansing | Michigan |
| United States | Arthritis and Osteoporosis Associates of New Mexico /ID# 252684 | Las Cruces | New Mexico |
| United States | Dartmouth-Hitchcock Medical Center /ID# 253798 | Lebanon | New Hampshire |
| United States | Bluegrass Community Research /ID# 254653 | Lexington | Kentucky |
| United States | Deerbrook Medical Associates /ID# 254008 | Libertyville | Illinois |
| United States | Physician Research Collaboration, LLC /ID# 254012 | Lincoln | Nebraska |
| United States | Valerius Medical Group & Research Center of Greater Long Beach, Inc /ID# 252692 | Los Alamitos | California |
| United States | West Texas Clinical Research /ID# 253736 | Lubbock | Texas |
| United States | Life Clinical Trials /ID# 256061 | Margate | Florida |
| United States | Atlanta Research Center for Rheumatology /ID# 254623 | Marietta | Georgia |
| United States | Lakes Research, LLC /ID# 255023 | Miami | Florida |
| United States | Paramount Medical Research and Consulting /ID# 254048 | Middleburg Heights | Ohio |
| United States | Trinity Health Med Arts Clinic /ID# 254010 | Minot | North Dakota |
| United States | The Arthritis & Diabetes Clinic, Inc. /ID# 254014 | Monroe | Louisiana |
| United States | Rheumatology Associates of Oklahoma /ID# 253994 | Oklahoma City | Oklahoma |
| United States | HMD Research LLC /ID# 253732 | Orlando | Florida |
| United States | Millennium Research /ID# 253744 | Ormond Beach | Florida |
| United States | Sun Valley Arthritis Center Ltd. /ID# 254654 | Peoria | Arizona |
| United States | Clinical Research of Philadelphia, LLC /ID# 255025 | Philadelphia | Pennsylvania |
| United States | Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 253432 | Phoenix | Arizona |
| United States | Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 255021 | Phoenix | Arizona |
| United States | Trinity Universal Research Associates, Inc /ID# 253995 | Plano | Texas |
| United States | Rheumatology Associates PA - Portland /ID# 255014 | Portland | Maine |
| United States | OrthoIllinois /ID# 254057 | Rockford | Illinois |
| United States | BayCare Medical Group /ID# 253799 | Saint Petersburg | Florida |
| United States | Sun Research Institute /ID# 255019 | San Antonio | Texas |
| United States | Rheumatology Center of San Diego /ID# 255038 | San Diego | California |
| United States | Greater Chicago Specialty Physicians /ID# 254000 | Schaumburg | Illinois |
| United States | Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 253999 | Skokie | Illinois |
| United States | Clinvest Research LLC /ID# 254054 | Springfield | Missouri |
| United States | BayCare Medical Group, Inc. /ID# 255268 | Tampa | Florida |
| United States | Clinical Research of West Florida - Tampa /ID# 255264 | Tampa | Florida |
| United States | Clinical Research of West Florida, Inc /ID# 254649 | Tampa | Florida |
| United States | University of South Florida- Neuroscience Institute /ID# 253745 | Tampa | Florida |
| United States | Advanced Rheumatology of Houston /ID# 254003 | The Woodlands | Texas |
| United States | Millennium Clinical Trials /ID# 252689 | Thousand Oaks | California |
| United States | DM Clinical Research - Tomball /ID# 254001 | Tomball | Texas |
| United States | Rheumatology Clinic of Houston /ID# 254002 | Tomball | Texas |
| United States | The Lundquist Institute at Harbor-UCLA Medical Center /ID# 252691 | Torrance | California |
| United States | Arizona Arthritis & Rheumatology Associates - Tucson /ID# 255017 | Tucson | Arizona |
| United States | Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 255266 | Voorhees | New Jersey |
| United States | Comprehensive Rheumatology Center /ID# 252688 | Woodland Hills | California |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
United States, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, France, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Mexico, Portugal, Puerto Rico, Romania, Serbia, South Africa, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) <= 3.2 | The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Low Disease Activity (LDA) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than or equal to 3.2. | Week 12 | |
| Secondary | Percentage of Participants Achieving American College of Rheumatology 50 % (ACR50) Response | Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:
50% improvement in tender joint count (TJC68); 50% improvement in swollen joint count (SJC66); and 50% improvement in at least 3 of the 5 following parameters: Physician's Global Assessment of Disease Activity measured on a Numerical Rating Scale of 0 to 10 (NRS) Patient's Global Assessment of Disease Activity (NRS) Patient's Assessment of Pain (NRS) Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP). |
Week 12 | |
| Secondary | Percentage of Participants Achieving Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) < 2.6 | The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Clinical remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than 2.6. | Week 12 | |
| Secondary | Change from Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) | The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. | Week 12 | |
| Secondary | Change from Baseline in Participants Assessment of Pain | Participants indicated their level of pain over the last 7 days using the Patient's Global Assessment Pain NRS. The range is 0 to 10 with no activity being indicated by 0 and severe activity by 10. | Week 12 | |
| Secondary | Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | The HAQ-DI assesses physical function in RA. The HAQ-DI score is the average of the highest score in each of eight categories. The total score is between 0-3.0, in 0.125 increments. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment. | Week 12 |
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