Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis (RA) Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04888585
• Other study ID #: M20-466
• Secondary ID: 2020-005303-39
• Status: Terminated
• Phase: Phase 2
• Start date: June 2, 2021
• Est. completion date: August 4, 2023

Study information

• Verified date: August 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. This study evaluates how safe and effective ABBV-154 is in participants treated for moderately to severely active RA. Adverse events and change in the disease activity will be assessed.

ABBV-154 is an investigational drug being evaluated for the treatment of RA. Study doctors place the participants in 1 of 5 treatment groups or arms, each arm receiving a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. Participants 18-75 years of age with moderate to severe RA will be enrolled. Around 425 participants will be enrolled in the study in approximately 270 sites worldwide.

The study is comprised of a 12-week placebo-controlled period, a double-blind long-term extension (LTE) period 1 of 66 weeks, a LTE period 2 of 104 weeks and a follow-up visit 70 days after the last dose of the study drug. In the LTE period 1, participants in the placebo group will be re-randomized to receive ABBV-154 in 2 different doses SC every other week (eow). Other participants will remain on their previous dose and dosing regimen of ABBV-154.

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, blood tests, checking for side effects and completing questionnaires.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 473
• Est. completion date: August 4, 2023
• Est. primary completion date: August 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of rheumatoid arthritis(RA) with fulfillment of the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA.

• Participant has >= 6 swollen joints (based on 66 joint count) and >=6 tender joints (based on 68 joint count) at baseline.

• Participant must have had an inadequate response to at least one prior biologic and/or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) treatment for RA.

• Participants must be on stable dose of methotrexate (MTX).

Exclusion Criteria:

• Participant discontinued prior adalimumab therapy due to intolerability or toxicity.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis (RA)

Intervention

Drug:
• ABBV-154
Subcutaneous Injection
• Placebo
Subcutaneous Injection

Locations

Country	Name	City	State
Australia	Emeritus Research Sydney /ID# 230070	Botany	New South Wales
Australia	Emeritus Research /ID# 229018	Camberwell	Victoria
Australia	Rheumatology Research Unit Sunshine Coast /ID# 229017	Maroochydore	Queensland
Australia	BJC Health /ID# 229015	Paramatta	New South Wales
Australia	The Queen Elizabeth Hospital /ID# 230071	Woodville South	South Australia
Canada	Rheumatology Research Associates /ID# 227818	Edmonton	Alberta
Canada	Groupe de Recherche en Maladies Osseuses Inc /ID# 227821	Sainte-foy	Quebec
Canada	Dr. Latha Naik /ID# 227823	Saskatoon	Saskatchewan
Canada	Centre de Recherche Musculo-Squelettique /ID# 227824	Trois-rivières	Quebec
Canada	Manitoba Clinic /ID# 227822	Winnipeg	Manitoba
Czechia	Fakultni Nemocnice v Motole /ID# 231622	Praha
Czechia	PV MEDICAL Services s.r.o. /ID# 228265	Praha
Czechia	Revmatologicka ambulance - MUDr. Zuzana Urbanova /ID# 227775	Praha
Czechia	Revmatologicky ustav v Praze /ID# 229188	Praha
Czechia	MEDICAL PLUS, s.r.o. /ID# 228030	Uherske Hradiste
Czechia	RHEUMA s.r.o. /ID# 230850	Velke Bilovice
Germany	Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 229526	Berlin
Germany	MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 227785	Hamburg
Germany	Rheumazentrum Ruhrgebiet /ID# 227850	Herne	Nordrhein-Westfalen
Greece	General Hospital of Athens Gennimatas /ID# 227806	Athens	Attiki
Greece	424 General MILITARY Hospital /ID# 227805	Efkarpia (Thessalonikis)	Thessaloniki
Greece	University General Hospital of Heraklion PA.G.N.I /ID# 227804	Heraklion	Kriti
Greece	General Hospital of Thessaloniki Hippokrateio /ID# 229614	Thessaloniki
Hungary	DRC Gyogyszervizsgalo Kozpont Kft /ID# 228365	Balatonfüred
Hungary	Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 227671	Budapest
Hungary	Obudai Egeszsegugyi Centrum Kft. /ID# 228359	Budapest	Pest
Hungary	Revita Reumatologiai Rendelo /ID# 227668	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont /ID# 228371	Debrecen	Hajdu-Bihar
Hungary	CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 227670	Szekesfehervar
Hungary	Vital Medical Center Orvosi es Fogaszati Kozpont (Vital Medicina Kft.) /ID# 227669	Veszprém
Hungary	Obudai Egeszsegugyi Centrum Kft. Zalaegerszeg /ID# 228374	Zalaegerszeg
Israel	Bnai Zion Medical Center /ID# 226801	Haifa
Israel	Rambam Health Care Campus /ID# 226798	Haifa
Israel	The Lady Davis Carmel Medical Center /ID# 226802	Haifa
Israel	Meir Medical Center /ID# 226800	Kfar Saba
Israel	The Chaim Sheba Medical Center /ID# 226797	Ramat Gan	Tel-Aviv
Israel	Tel Aviv Sourasky Medical Center /ID# 228341	Tel Aviv-Yafo	Tel-Aviv
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 228581	Ancona
Italy	Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 228583	Palermo
Italy	Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 228917	Rome	Lazio
Japan	Katayama Orthopedic Rheumatology Clinic /ID# 229277	Asahikawa-shi	Hokkaido
Japan	St.Luke's International Hospital /ID# 229492	Chuo-ku	Tokyo
Japan	Sugimoto rheumatology and internal medicine clinic /ID# 229495	Fukui-shi	Fukui
Japan	National Hospital Organization Kyushu Medical Center /ID# 228642	Fukuoka shi	Fukuoka
Japan	Hamanomachi Hospital /ID# 228644	Fukuoka-shi	Fukuoka
Japan	Shono Rheumatism Clinic /ID# 229054	Fukuoka-shi	Fukuoka
Japan	Matsubara Mayflower Hospital /ID# 228948	Kato-shi	Hyogo
Japan	National Hospital Organization Osaka Minami Medical Center /ID# 229174	Kawachinagano Shi	Osaka
Japan	Bay Side Misato Medical Center /ID# 228947	Kochi-shi	Kochi
Japan	Kumamoto Orthopaedic Hospital /ID# 228641	Kumamoto shi	Kumamoto
Japan	National Hospital Organization Tokyo Medical Center /ID# 228720	Meguro-ku	Tokyo
Japan	Medical Corporation Keiai Kai Clinic /ID# 228547	Miyazaki-shi	Miyazaki
Japan	Nagaoka Red Cross Hospital /ID# 229962	Nagaoka-shi	Niigata
Japan	Daido Clinic /ID# 229280	Nagoya-shi	Aichi
Japan	Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 229899	Nagoya-shi	Aichi
Japan	Japanese Red Cross Osaka Hospital /ID# 229816	Osaka-shi	Osaka
Japan	Osaka City General Hospital /ID# 228786	Osaka-shi	Osaka
Japan	Sanuki Municipal Hospital /ID# 229276	Sanuki-shi	Kagawa
Japan	Sagawa Akira Rheumatology Clin /ID# 228787	Sapporo-shi	Hokkaido
Japan	Sasebo Chuo Hospital /ID# 229168	Sasebo-shi	Nagasaki
Japan	Azuma Rheumatology Clinic /ID# 230078	Sayama-shi	Saitama
Japan	Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 228354	Shimonoseki-shi	Yamaguchi
Japan	Medical Corporation Uchida Clinic /ID# 229494	Sumida-ku	Tokyo
Korea, Republic of	SoonChunHyang University CheonAn Hospital /ID# 228146	Cheonan-si	Chungcheongnamdo
Korea, Republic of	Kyungpook National University Hospital /ID# 227657	Daegu
Korea, Republic of	Inha University Hospital /ID# 227656	Incheon
Korea, Republic of	Asan Medical Center /ID# 227655	Seoul
Korea, Republic of	Hanyang University Seoul Hospital /ID# 227658	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Yonsei University Health System Severance Hospital /ID# 227659	Seoul	Seoul Teugbyeolsi
Netherlands	Academisch Medisch Centrum /ID# 227234	Amsterdam
Netherlands	Maastricht Universitair Medisch Centrum /ID# 227235	Maastricht
New Zealand	Wellington Regional Hospital /ID# 233517	Newtown	Wellington
New Zealand	Middlemore Clinical Trials /ID# 229012	Papatoetoe	Auckland
New Zealand	Timaru Medical Specialists Ltd /ID# 229013	Timaru	Canterbury
Poland	ClinicMed Daniluk, Nowak Sp.j. /ID# 227919	Bialystok	Podlaskie
Poland	Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 227939	Bydgoszcz	Kujawsko-pomorskie
Poland	Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 228047	Gdansk	Pomorskie
Poland	AMICARE Sp. z o.o. sp.k. /ID# 231327	Lodz	Lodzkie
Poland	SANUS Szpital Specjalistyczny /ID# 227171	Stalowa Wola	Podkarpackie
Poland	Medycyna Kliniczna /ID# 231133	Warsaw
Poland	Centrum Medyczne Reuma Park /ID# 227170	Warszawa	Mazowieckie
Puerto Rico	GCM Medical Group PSC /ID# 228981	San Juan
Puerto Rico	Mindful Medical Research /ID# 228982	San Juan
Russian Federation	Kazan State Medical University /ID# 227927	Kazan	Tatarstan, Respublika
Russian Federation	LLC Family Outpatient Clinic No /ID# 227926	Korolev	Moskva
Russian Federation	Central Clinical Hospital of Russian Academy of Science /ID# 229438	Moscow
Russian Federation	Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 228755	Moscow	Moskovskaya Oblast
Russian Federation	Euromedservice /ID# 227933	Pushkin
Russian Federation	Clinical Rheumatologic Hospital No 25 /ID# 227922	St. Petersburg
Russian Federation	Family Clinic /ID# 227929	Yekaterinburg	Sverdlovskaya Oblast
Slovakia	MEDMAN s.r.o. /ID# 227826	Martin
Slovakia	Reum.hapi s.r.o. /ID# 227825	Nove Mesto nad Vahom
Slovakia	Thermium s.r.o. /ID# 227816	Piestany
Slovakia	REUMAMED POPRAD s.r.o. /ID# 229628	Poprad
Slovakia	Reumex, s.r.o. /ID# 227827	Rimavska Sobota
Spain	Hospital Universitario A Coruna - CHUAC /ID# 227419	A Coruna
Spain	Hospital Universitario Basurto /ID# 227667	Bilbao	Vizcaya
Spain	Hospital Universitario 12 de Octubre /ID# 227743	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz /ID# 234115	Madrid
Spain	Hospital Regional de Malaga /ID# 227418	Málaga	Malaga
Spain	Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 227666	Sabadell	Barcelona
Spain	Hospital Clínico Universitario de Santiago-CHUS /ID# 227420	Santiago de Compostela	A Coruna
Spain	Hospital Universitario Virgen de Valme /ID# 227417	Sevilla
Spain	Hospital Universitario y Politecnico La Fe /ID# 227408	Valencia
Taiwan	Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 227220	Chia-Yi
Taiwan	Far Eastern Memorial Hospital /ID# 227373	New Taipei City
Taiwan	National Taiwan University Hospital /ID# 230001	Taipei City
Taiwan	Taipei Veterans General Hosp /ID# 227376	Taipei City
Turkey	Ankara Univ Medical Faculty /ID# 227797	Ankara
Turkey	Kocaeli University Med Faculty /ID# 228244	Kocaeli
Turkey	Hacettepe Universitesi Tip Fak /ID# 227796	Sihhiye	Ankara
Ukraine	MNI City Multidisciplinary Hospital #18 /ID# 228961	Kharkiv
Ukraine	Khmelnytskyi Regional Hospital /ID# 230680	Khmelnytskyi
Ukraine	Medical Center "OK!Clinic+" /ID# 228958	Kyiv
Ukraine	Medical Center CONSILIUM MEDICAL /ID# 228959	Kyiv
Ukraine	Medical Center of Medical Clinic Blagomed LLC /ID# 228956	Kyiv
Ukraine	PI "Poltava Regional Clinical Hospital n.a. M.V.Sklifosovsky" /ID# 228962	Poltava
Ukraine	Clinic of Scientific Research Institute of Invalid Rehabilitation /ID# 228955	Vinnytsia
Ukraine	CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 228954	Vinnytsia
United States	Albuquerque Center For Rheumatology /ID# 228709	Albuquerque	New Mexico
United States	Albuquerque Clinical Trials, Inc /ID# 228925	Albuquerque	New Mexico
United States	Allen Arthritis /ID# 228712	Allen	Texas
United States	Arthritis and Rheumatology Research Institute, PLLC /ID# 228937	Allen	Texas
United States	Arthritis and Rheumatology /ID# 228743	Atlanta	Georgia
United States	Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 228229	Boca Raton	Florida
United States	Bay Area Arthritis and Osteo /ID# 228075	Brandon	Florida
United States	New England Research Associates, LLC /ID# 230127	Bridgeport	Connecticut
United States	Trinity Universal Research Associates - Carrollton /ID# 230104	Carrollton	Texas
United States	DJL Clinical Research, PLLC /ID# 230133	Charlotte	North Carolina
United States	Great Lakes Clinical Trials /ID# 228699	Chicago	Illinois
United States	University of Cincinnati /ID# 229212	Cincinnati	Ohio
United States	Clinical Research of West Florida, Inc /ID# 228128	Clearwater	Florida
United States	Columbia Arthritis Center /ID# 228705	Columbia	South Carolina
United States	Adriana Pop-Moody MD Clinic PA /ID# 230062	Corpus Christi	Texas
United States	Advanced Rheumatology & Arthritis Wellness Center /ID# 228608	Cranberry Township	Pennsylvania
United States	International Medical Research - Daytona /ID# 228069	Daytona Beach	Florida
United States	Omega Research Debary, LLC /ID# 228293	DeBary	Florida
United States	Jefrey D. Lieberman, MD, P.C. /ID# 230129	Decatur	Georgia
United States	Denver Arthritis Clinic /ID# 228172	Denver	Colorado
United States	Altoona Ctr Clinical Res /ID# 230058	Duncansville	Pennsylvania
United States	Arthritis and Osteoporosis Associates /ID# 229418	Freehold	New Jersey
United States	Providence Medical Foundation /ID# 228104	Fullerton	California
United States	Arthritis Center of North GA /ID# 228769	Gainesville	Georgia
United States	AA Medical Research Center - Grand Blanc /ID# 228604	Grand Blanc	Michigan
United States	Beacon Medical Group Clinical Research /ID# 229153	Granger	Indiana
United States	Klein and Associates MD - Hagerstown /ID# 230143	Hagerstown	Maryland
United States	Klein and Associates MD /ID# 230145	Hagerstown	Maryland
United States	Arthritis Associates /ID# 230188	Hattiesburg	Mississippi
United States	Sweet Hope Research Specialty Inc /ID# 228753	Hialeah	Florida
United States	Rheumatology Clinic of Houston /ID# 228178	Houston	Texas
United States	Care Access Research, Huntington Beach /ID# 228163	Huntington Beach	California
United States	University of Iowa Hospitals and Clinics /ID# 229217	Iowa City	Iowa
United States	West Tennessee Research Institute /ID# 228257	Jackson	Tennessee
United States	University of Florida /ID# 228242	Jacksonville	Florida
United States	Arthritis and Rheumatism Associates /ID# 228201	Jonesboro	Arkansas
United States	Logan Health Research /ID# 228273	Kalispell	Montana
United States	San Diego Rheumatology /ID# 228120	La Mesa	California
United States	Arthritis & Osteo Medical Ctr /ID# 228239	La Palma	California
United States	Advanced Rheumatology, PC /ID# 228684	Lansing	Michigan
United States	June DO, PC /ID# 229838	Lansing	Michigan
United States	Arthritis and Osteo Assoc /ID# 228662	Las Cruces	New Mexico
United States	Advanced Biomedical Research of America /ID# 228596	Las Vegas	Nevada
United States	Innovative Health Research /ID# 229209	Las Vegas	Nevada
United States	Cape Fear Arthritis Care /ID# 228747	Leland	North Carolina
United States	Delaware Arthritis /ID# 229413	Lewes	Delaware
United States	Pacific Arthritis Care Center - Los Angeles /ID# 229330	Los Angeles	California
United States	West Texas Clinical Research /ID# 228276	Lubbock	Texas
United States	P&I Clinical Research /ID# 230183	Lufkin	Texas
United States	Atlanta Research Center for Rheumatology /ID# 230430	Marietta	Georgia
United States	SW Rheumatology Res. LLC /ID# 228088	Mesquite	Texas
United States	Lakes Research, LLC /ID# 228665	Miami	Florida
United States	University of Miami /ID# 228737	Miami	Florida
United States	Paramount Medical Research Con /ID# 228254	Middleburg Heights	Ohio
United States	Trinity Health Med Arts Clinic /ID# 228202	Minot	North Dakota
United States	The Arthritis & Diabetes Clinic, Inc. /ID# 228221	Monroe	Louisiana
United States	Suncoast Clinical Research /ID# 228237	New Port Richey	Florida
United States	Tidewater Physicians Medical Center /ID# 230130	Newport News	Virginia
United States	California Medical Research Associates /ID# 230131	Northridge	California
United States	Arthritis and Rheumatology Center of Oklahoma /ID# 228975	Oklahoma City	Oklahoma
United States	Rheumatology Associates of Oklahoma /ID# 228701	Oklahoma City	Oklahoma
United States	Buffalo Rheumatology and Medicine - Orchard Park /ID# 228710	Orchard Park	New York
United States	HMD Research LLC /ID# 228185	Orlando	Florida
United States	Omega Research Maitland, LLC /ID# 229966	Orlando	Florida
United States	Millennium Research /ID# 228183	Ormond Beach	Florida
United States	Four Rivers Clinical Research /ID# 230109	Paducah	Kentucky
United States	Arthritis Center, Inc. /ID# 228209	Palm Harbor	Florida
United States	Arthritis Group /ID# 229777	Philadelphia	Pennsylvania
United States	Elite Clinical Studies, LLC /ID# 228227	Phoenix	Arizona
United States	Trinity Universal Research Associates, Inc /ID# 228238	Plano	Texas
United States	St. Lawrence Health System /ID# 229508	Potsdam	New York
United States	Arthritis Care And Research Center ACRC /ID# 230099	Poway	California
United States	Epic Medical Research /ID# 228097	Red Oak	Texas
United States	Clayton Medical Associates, P.C. dba Saint Louis Rheumatology /ID# 228283	Saint Louis	Missouri
United States	West County Rheumatology /ID# 228102	Saint Louis	Missouri
United States	BayCare Medical Group /ID# 228289	Saint Petersburg	Florida
United States	PMG Research of Salisbury /ID# 230627	Salisbury	North Carolina
United States	Sun Research Institute /ID# 228768	San Antonio	Texas
United States	East Bay Rheumatology Medical /ID# 228099	San Leandro	California
United States	Greater Chicago Specialty Physicians /ID# 228282	Schaumburg	Illinois
United States	Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 228174	Skokie	Illinois
United States	Arthritis Northwest, PLLC /ID# 228275	Spokane	Washington
United States	Springfield Clinic /ID# 228124	Springfield	Illinois
United States	Stamford Therapeutics Consorti /ID# 229214	Stamford	Connecticut
United States	West Broward Rheumatology Associates /ID# 228603	Tamarac	Florida
United States	Clinical Research of West Florida - Tampa /ID# 228186	Tampa	Florida
United States	Advanced Rheumatology of Houston /ID# 228170	The Woodlands	Texas
United States	Millennium Clinical Trials /ID# 230618	Thousand Oaks	California
United States	Arthritis Assoc of NW Ohio /ID# 228936	Toledo	Ohio
United States	DM Clinical Research - Tomball /ID# 228112	Tomball	Texas
United States	The Lundquist Institute at Harbor-UCLA Medical Center /ID# 228241	Torrance	California
United States	Medvin Clinical Research /ID# 228181	Tujunga	California
United States	Rheumatology Consultants - Clinical Research /ID# 229208	Tupelo	Mississippi
United States	Inland Rheum & Osteo Med Grp /ID# 228204	Upland	California
United States	Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 228602	Voorhees	New Jersey
United States	Arthritis & Osteoporosis Clinic /ID# 228736	Waco	Texas
United States	Comprehensive Rheumatology Center /ID# 230132	West Hills	California
United States	The Center for Rheumatology and Bone Research /ID# 228617	Wheaton	Maryland
United States	Conquest Research /ID# 230560	Winter Park	Florida
United States	PA Regional Center for Arthritis and Osteoporosis Research /ID# 228742	Wyomissing	Pennsylvania
United States	Florida Medical Clinic /ID# 228236	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czechia,  Germany,  Greece,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  New Zealand,  Poland,  Puerto Rico,  Russian Federation,  Slovakia,  Spain,  Taiwan,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 68-tender joint count; = 50% improvement in 66-swollen joint count; 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).	At 12 weeks
Secondary	Change in Disease Activity Score (DAS) 28 (CRP) from Baseline	The DAS28 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 hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.	Up to 12 weeks
Secondary	Change in Clinical Disease Activity Index (CDAI) from Baseline	CDAI is a composite index for assessing disease activity based on the sum of the total 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 Physician's Global Assessment of Disease Activity (NRS). The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity.	Up to 12 weeks
Secondary	Percentage of Participants Achieving American College of Rheumatology 20 % (ACR20) Response	Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria: = 20% improvement in 68-tender joint count; = 20% improvement in 66-swollen joint count; and; = 20% improvement in at least 3 of the 5 following parameters: Physician's Global Assessment of Disease Activity (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).	At 12 weeks
Secondary	Percentage of Participants Achieving American College of Rheumatology 70 % (ACR70) Response	Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria: = 70% improvement in 68-tender joint count; = 70% improvement in 66-swollen joint count; and; = 70% improvement in at least 3 of the 5 following parameters: Physician's Global Assessment of Disease Activity (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).	At 12 weeks
Secondary	Percentage of Participants Achieving Low Disease Activity (LDA) Defined by DAS28 (CRP) <= 3.2	Low disease activity (LDA) was defined as a DAS28 score less than or equal to 3.2. The DAS28 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 Physician's Global Assessment of Disease Activity (NRS), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.	At 12 weeks
Secondary	Percentage of Participants Achieving LDA Defined by CDAI <= 10	Low disease activity based on CDAI is defined as a CDAI score less than or equal to 10. CDAI is a composite index for assessing disease activity based on the sum of the total 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 Physician's Global Assessment of Disease Activity (NRS). The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity.	At 12 weeks
Secondary	Percentage of Participants Achieving Clinical Remission (CR) Defined by DAS28 (CRP) < 2.6	Clinical remission was defined as a DAS28 (CRP) score less than 2.6. The DAS28 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 hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.	At 12 weeks
Secondary	Percentage of Participants Achieving CR Defined by CDAI <= 2.8	Clinical Remission was defined by CDAI as a score less than or equal to 2.8. CDAI is a composite index for assessing disease activity based on the summation of the total 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 Physician's Global Assessment of Disease Activity (NRS). The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity.	At 12 weeks
Secondary	Change in the Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline	The Health Assessment Questionnaire - Disability Index is a participant-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.; A negative change from Baseline in the overall score indicates improvement.	Up to 12 weeks