A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs

Rheumatoid Arthritis Clinical Trial

— SELECT-BEYOND  

Official title:

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02706847
• Other study ID #: M13-542
• Secondary ID: 2015-003335-35
• Status: Completed
• Phase: Phase 3
• Start date: March 15, 2016
• Est. completion date: February 8, 2022

Study information

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

Clinical Trial Summary

The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD.

The study objective of Period 2 (Week 24 to Week 260) is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants with RA who completed Period 1.

Description:

This study includes a 35-day screening period; a 24-week randomized, double-blind, parallel-group, placebo controlled treatment period (Period 1); a 236-week blinded long-term extension period (Period 2); and a 30-day follow-up period (call or visit).

Period 1 consists of a 12-week double-blind, placebo-controlled treatment phase plus a 12-week double-blind phase where all participants were to receive upadacitinib; at Week 12 participants assigned to placebo will be switched to upadacitinib according to their randomization assignment.

Participants who meet eligibility criteria will be randomized in a 2:2:1:1 ratio to one of four treatment groups:

• Group 1: Upadacitinib 30 mg QD (Day 1 to Week 12) → upadacitinib 30 mg QD (Week 12 and thereafter)

• Group 2: Upadacitinib 15 mg QD (Day 1 to Week 12) → upadacitinib 15 mg QD (Week 12 and thereafter)

• Group 3: Placebo (Day 1 to Week 12) → upadacitinib 30 mg QD (Week 12 and thereafter)

• Group 4: Placebo (Day 1 to Week 12) → upadacitinib 15 mg QD (Week 12 and thereafter)

Participants will continue stable dose of csDMARD therapy for the first 24 weeks of the study.

Participants who complete the Week 24 visit (end of Period 1) will enter the blinded long-term extension portion of the study, Period 2 and continue to receive the same dose of upadacitinib per original randomization assignment in a blinded manner. Starting at Week 24, at least 20% improvement in both swollen joint count (SJC) and tender joint count (TJC) compared to Baseline is required to remain on study drug. Starting at Week 24, initiation of or change in corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, or adding or increasing doses in up to 2 csDMARDs (concomitant use of up to 2 csDMARDs except the combination of methotrexate and leflunomide) is allowed as per local label.

With the implementation of Protocol Amendment 4, all participants in the extension period will receive open-label upadacitinib 15 mg QD, including those currently on upadacitinib 30 mg QD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 499
• Est. completion date: February 8, 2022
• Est. primary completion date: April 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Diagnosis of rheumatoid arthritis (RA) for= 3 months.

• Treated for = 3 months with = 1 bDMARD therapy, but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration prior to the first dose of study drug.

• Participant has been receiving csDMARD therapy = 3 months and on a stable dose for = 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide. A combination of up to two background csDMARDs is allowed except the combination of MTX and leflunomide.

• Meets both of the following criteria:

• = 6 swollen joints (based on 66 joint counts) and = 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.

• hsCRP = 3mg/L at Screening Visit.

Exclusion Criteria:

• Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).

• 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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Placebo
Tablet; Oral
• Upadacitinib
Tablet; Oral

Locations

Country	Name	City	State
Australia	Emeritus Research /ID# 142416	Camberwell	Victoria
Australia	The Queen Elizabeth Hospital /ID# 142419	Woodville	South Australia
Austria	Universitaetsklinik fuer Inner /ID# 142423	Graz
Austria	Medizinische Universität Wien /ID# 142424	Vienna	Wien
Austria	Rheuma Zentrum Favoriten GmbH /ID# 142421	Vienna
Austria	Rheuma-Zentrum Wien-Oberlaa /ID# 142425	Wien
Austria	Wilhelminenspital der Stadt Wien /ID# 142422	Wien
Belgium	Rhumaconsult SPRL /ID# 151378	Charleroi	Hainaut
Belgium	ReumaClinic Genk /ID# 142431	Genk
Belgium	UZ Gent /ID# 142429	Gent	Oost-Vlaanderen
Belgium	AZ Damiaan /ID# 142427	Oostende
Belgium	Cliniques Universitaires Saint Luc /ID# 142426	Woluwe-Saint-Lambert	Bruxelles-Capitale
Canada	Ciads /Id# 142526	Winnipeg	Manitoba
Czechia	Revmatologie MUDr. Klara Sirova /ID# 142536	Ostrava
Czechia	Medical Plus, s.r.o. /ID# 148345	Uherské Hradište
Estonia	East Tallinn Central Hospital /ID# 142543	Tallinn
Estonia	MediTrials /ID# 151777	Tartu	Tartumaa
Finland	Kiljava Medical Research /ID# 142546	Hyvinkaa
Finland	Paijat-Hame Central Hospital /ID# 149185	Lahti
France	CHU Bordeaux-Hopital Pellegrin /ID# 144700	Bordeaux
France	Centre Hospitalier Jean Rougie /ID# 142556	Cahors
France	Centre Hospitalier Le Mans /ID# 145956	Le Mans CEDEX 9	Sarthe
France	Hopital Edouard Herriot /ID# 144698	Lyon
France	Hopital Saint Eloi /ID# 142552	Montpellier CEDEX 5	Herault
France	CHR Orleans - Hopital de la Source /ID# 142557	Orleans CEDEX 2	Centre-Val De Loire
France	Hopital Universitaire Purpan /ID# 144697	Toulouse	Haute-Garonne
Germany	Charité Universitätsmedizin Campus Mitte /ID# 142559	Berlin
Germany	Asklepios Klinik Altona /ID# 142561	Hamburg
Germany	Rheumaforschungszentrum II /ID# 142560	Hamburg
Germany	Schoen Klinikum Hamburg Eilbek /ID# 142566	Hamburg
Germany	Rheumazentrum Ruhrgebiet /ID# 145600	Herne	Nordrhein-Westfalen
Germany	Uniklinik Koln /ID# 142563	Köln	Nordrhein-Westfalen
Germany	LMU Klinikum der Universität München /ID# 142564	Munich
Germany	MVZ Planegg /ID# 142565	Planegg
Germany	Knappschaftsklinikum Saar /ID# 142562	Püttlingen
Greece	General Hospital of Athens Laiko /ID# 142579	Athens	Attiki
Hungary	Revita Reumatologiai Rendelo /ID# 142590	Budapest
Hungary	Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 142587	Debrecen
Hungary	Bekes Megyei Pandy Kalman Korh /ID# 142588	Gyula
Hungary	Vital Medical Center Orvosi es /ID# 142586	Veszprém	Veszprem
Ireland	St Vincent's University Hosp /ID# 142593	Dublin
Israel	Bnai Zion Medical Center /ID# 151945	Haifa
Israel	The Lady Davis Carmel MC /ID# 142599	Haifa
Israel	Tel Aviv Sourasky Medical Ctr /ID# 142597	Tel Aviv-Yafo	Tel-Aviv
Korea, Republic of	Inha University Hospital /ID# 150881	Incheon
Korea, Republic of	Hanyang University Seoul Hospi /ID# 150883	Seoul	Seongdong-gu
Korea, Republic of	Seoul National University Hospital /ID# 142622	Seoul
Latvia	LTD M+M Centers /ID# 142624	Adazi
Latvia	Arthritis Clinic Ltd /ID# 153560	Riga
Latvia	P. Stradins Clinical Univ Hosp /ID# 142623	Riga
New Zealand	Timaru Medical Specialists Ltd /ID# 142657	Timaru
Poland	Centrum Medyczne Pratia Gdynia /ID# 142666	Gdynia	Pomorskie
Poland	Pratia MCM Krakow /ID# 142664	Krakow	Malopolskie
Poland	Centrum Medyczne Pratia Warszawa /ID# 142667	Warsaw	Mazowieckie
Poland	Centrum Medyczne AMED Warszawa Targowek /ID# 142663	Warszawa	Mazowieckie
Poland	WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 142665	Wroclaw	Dolnoslaskie
Portugal	Centro Hospitalar Lisboa Norte, EPE /ID# 142668	Lisboa
Portugal	Centro Hospitalar De Vila Nova /ID# 142670	Vila Nova De Gaia	Porto
Puerto Rico	GCM Medical Group /ID# 142671	San Juan
Russian Federation	Family Outpatient clinic#4,LLC /ID# 150910	Korolev	Moskva
Slovakia	ARTROMAC n.o. /ID# 142692	Kosice
Slovakia	Nemocnica Kosice Saca, a.s. /ID# 142693	Kosice
Slovakia	Narodny ustav reumatickych chorob Piestany /ID# 142691	Pieštany
Spain	Comple Hosp Univ de A Coruna /ID# 142708	A Coruna
Spain	Hospital Clin Univ San Carlos /ID# 142711	Madrid
Spain	Hospital Regional de Malaga /ID# 142707	Málaga	Malaga
Spain	H. Un. Marques de Valdecilla /ID# 142706	Santander	Cantabria
Spain	Clinica Gaias /ID# 142709	Santiago de Compostela
Spain	Hospital Universitario La Fe /ID# 142716	Valencia
Sweden	Sahlgrenska University Hosp /ID# 142720	Goteborg
Sweden	Capio Movement Halmstad /ID# 148236	Halmstad
Sweden	Orebro Universitetssjukhuset /ID# 142718	Orebro
Sweden	Vastmanlands Sjukhus /ID# 142721	Vasteras
Switzerland	Universitaetsspital Basel /ID# 145610	Basel
Switzerland	HFR Fribourg - Hopital Canton /ID# 142723	Fribourg
Turkey	Ankara Ataturk Training & Res /ID# 142727	Ankara
Turkey	Hacettepe University Medical Faculty /ID# 142729	Ankara
Turkey	Ondokuz mayis University Facul /ID# 142728	Samsun
United Kingdom	Mid Essex Hospitals NHS Trust /ID# 148992	Chelmsford
United Kingdom	Western General Hospital /ID# 142732	Edinburgh
United Kingdom	West Suffolk Hospital /ID# 148993	Ipswich
United Kingdom	The Royal Free Hospital /ID# 142733	London	London, City Of
United Kingdom	Whipps Cross Univ Hospital /ID# 145957	London	London, City Of
United Kingdom	Queen Alexandra Hospital /ID# 142735	Portsmouth
United Kingdom	Arrowe Park Hospital /ID# 148991	Wirral
United States	The Center for Rheumatology /ID# 142784	Albany	New York
United States	Tekton Research, Inc. /ID# 142805	Austin	Texas
United States	Diagnostic Group Integrated He /ID# 148340	Beaumont	Texas
United States	East Penn Rheumatology Assoc /ID# 142790	Bethlehem	Pennsylvania
United States	St. Luke's Clinic - Rheumatolo /ID# 150923	Boise	Idaho
United States	Western Washington Arthritis C /ID# 142776	Bothell	Washington
United States	New England Research Associates, LLC /ID# 142763	Bridgeport	Connecticut
United States	DJL Clinical Research, PLLC /ID# 142769	Charlotte	North Carolina
United States	Joint & Muscle Research Instit /ID# 142797	Charlotte	North Carolina
United States	Great Lakes Clinical Trials /ID# 148341	Chicago	Illinois
United States	Cincinnati Rheumatic Disease Study Group, Inc. /ID# 142791	Cincinnati	Ohio
United States	Arth and Osteo Clin Brazo Valley /ID# 148343	College Station	Texas
United States	Arthritis Assoc & Osteo Ctr /ID# 142809	Colorado Springs	Colorado
United States	Columbia Arthritis Center /ID# 153728	Columbia	South Carolina
United States	Covina Arthritis Clinic /ID# 142794	Covina	California
United States	Arthritis Care and Diagnostic /ID# 151344	Dallas	Texas
United States	Metroplex Clinical Research /ID# 142758	Dallas	Texas
United States	Jefrey D. Lieberman, MD, P.C. /ID# 151713	Decatur	Georgia
United States	Denver Arthritis Clinic /ID# 142771	Denver	Colorado
United States	Rheumatology Ctr of San Diego /ID# 153576	Escondido	California
United States	Aurora Rheumatology and Immunotherapy Center /ID# 142820	Franklin	Wisconsin
United States	St. Joseph Heritage Healthcare /ID# 149273	Fullerton	California
United States	Baylor College of Medicine /ID# 142753	Houston	Texas
United States	Houston Institute for Clin Res /ID# 142768	Houston	Texas
United States	Pioneer Research Solutions, Inc. /ID# 151346	Houston	Texas
United States	Rheumatic Disease Clin Res Ctr /ID# 150914	Houston	Texas
United States	Rheumatology Clinic of Houston /ID# 150915	Houston	Texas
United States	Rheum Assoc of North Alabama /ID# 145959	Huntsville	Alabama
United States	Institute of Arthritis Res /ID# 142810	Idaho Falls	Idaho
United States	West Tennessee Research Inst /ID# 142739	Jackson	Tennessee
United States	NEA Baptist Clinic /ID# 149280	Jonesboro	Arkansas
United States	Arthritis Associates, PLLC /ID# 142774	Kingsport	Tennessee
United States	Arthritis Associates, PLLC /ID# 155462	Kingsport	Tennessee
United States	TriWest Research Associates- La Mesa /ID# 142792	La Mesa	California
United States	Arthritis & Osteo Medical Ctr /ID# 142770	La Palma	California
United States	June DO, PC /ID# 142756	Lansing	Michigan
United States	Dartmouth-Hitchcock Medical Center /ID# 145958	Lebanon	New Hampshire
United States	Cape Fear Arthritis Care /ID# 148344	Leland	North Carolina
United States	Delaware Arthritis /ID# 142803	Lewes	Delaware
United States	Valerius Med Grp & Res Ctr /ID# 142799	Los Alamitos	California
United States	Pacific Arthritis Ctr Med Grp /ID# 142783	Los Angeles	California
United States	University of California, Los Angeles /ID# 148348	Los Angeles	California
United States	Arthritis & Osteoporosis Assoc /ID# 147567	Lubbock	Texas
United States	P&I Clinical Research /ID# 151345	Lufkin	Texas
United States	Mansfield Health Center /ID# 147628	Mansfield	Massachusetts
United States	Marietta Rheumatology Assoc /ID# 151347	Marietta	Georgia
United States	Dr. Ramesh Gupta /ID# 142767	Memphis	Tennessee
United States	Advanced Clinical Research /ID# 153089	Meridian	Idaho
United States	AZ Arthritis and Rheum Assoc /ID# 148593	Mesa	Arizona
United States	SW Rheumatology Res. LLC /ID# 142813	Mesquite	Texas
United States	Lakes Research, LLC /ID# 142755	Miami	Florida
United States	Trinity Health Med Arts Clinic /ID# 142754	Minot	North Dakota
United States	The Arthritis & Diabetes Clinic, Inc. /ID# 142793	Monroe	Louisiana
United States	Medallion Clinical Research Institute, LLC /ID# 142740	Naples	Florida
United States	Coastal Carolina Health Care /ID# 148351	New Bern	North Carolina
United States	North Shore University Hospital /ID# 142772	New Hyde Park	New York
United States	Health Research Oklahoma /ID# 142751	Oklahoma City	Oklahoma
United States	Westroads Clinical Research /ID# 142802	Omaha	Nebraska
United States	Buffalo Rheumatology /ID# 142766	Orchard Park	New York
United States	Omega Research Consultants /ID# 142780	Orlando	Florida
United States	Millennium Research /ID# 142782	Ormond Beach	Florida
United States	Desert Medical Advances /ID# 142765	Palm Desert	California
United States	Arthritis Center, Inc. /ID# 142822	Palm Harbor	Florida
United States	Arthritis Research of Florida /ID# 142811	Palm Harbor	Florida
United States	Arizona Research Center, Inc. /ID# 142741	Phoenix	Arizona
United States	AZ Arthritis and Rheum Researc /ID# 142816	Phoenix	Arizona
United States	AZ Arthritis and Rheum Researc /ID# 146075	Phoenix	Arizona
United States	AZ Arthritis and Rheum Researc /ID# 148592	Phoenix	Arizona
United States	Advent Clinical Research /ID# 142817	Pinellas Park	Florida
United States	Trinity Universal Research Association /ID# 149278	Plano	Texas
United States	MMP Women's Health /ID# 145612	Portland	Maine
United States	AZ Arthr & Rheum Research /ID# 155256	Prescott	Arizona
United States	Shanahan Rheuma & Immuno /ID# 142812	Raleigh	North Carolina
United States	Barbara Caciolo, MD /ID# 142749	Saint Louis	Missouri
United States	Clayton Medical Associates dba Saint Louis Rheumatology /ID# 142745	Saint Louis	Missouri
United States	St. Anthony Comprehsve Res Ins /ID# 148349	Saint Petersburg	Florida
United States	Arthritis & Osteo Ctr of S. TX /ID# 142773	San Antonio	Texas
United States	Arthritis Clinic of Central TX /ID# 148346	San Marcos	Texas
United States	Vanguard Medical Research, LLC /ID# 153123	Shreveport	Louisiana
United States	Clinical Investigation Special /ID# 149270	Skokie	Illinois
United States	West Virginia Research Inst /ID# 153087	South Charleston	West Virginia
United States	Arthritis Northwest, PLLC /ID# 150924	Spokane	Washington
United States	Springfield Clinic /ID# 142818	Springfield	Illinois
United States	Stanford University School of Med /ID# 142761	Stanford	California
United States	AZ Arthritis & Rheum Research /ID# 156090	Sun City	Arizona
United States	BayCare Medical Group, Inc. /ID# 142747	Tampa	Florida
United States	University of South Florida /ID# 145611	Tampa	Florida
United States	DM Clinical Research /ID# 151007	Tomball	Texas
United States	Atlantic Coast Research /ID# 148347	Toms River	New Jersey
United States	Ocean Rheumatology, PA /ID# 142785	Toms River	New Jersey
United States	Healthcare Research Consultant /ID# 142815	Tulsa	Oklahoma
United States	North Mississippi Med Clinics /ID# 142781	Tupelo	Mississippi
United States	Robin K. Dore MD, Inc /ID# 150908	Tustin	California
United States	Inland Rheum Clin Trials Inc. /ID# 142787	Upland	California
United States	The Vancouver Clinic, INC. PS /ID# 147946	Vancouver	Washington
United States	STAT Research, Inc. /ID# 142821	Vandalia	Ohio
United States	Lovelace Scientific Resources /ID# 142779	Venice	Florida
United States	Deerbrook Medical Associates /ID# 151712	Vernon Hills	Illinois
United States	Arthritis & Osteoporosis Clinic /ID# 142760	Waco	Texas
United States	The Center for Rheumatology & /ID# 142742	Wheaton	Maryland
United States	Medvin Clinical Research /ID# 142814	Whittier	California
United States	Clinical Pharmacology Study Gr /ID# 142744	Worcester	Massachusetts
United States	Clinical Research Ctr Reading /ID# 151714	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czechia,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Israel,  Korea, Republic of,  Latvia,  New Zealand,  Poland,  Portugal,  Puerto Rico,  Russian Federation,  Slovakia,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

References & Publications (1)

Genovese MC, Fleischmann R, Combe B, Hall S, Rubbert-Roth A, Zhang Y, Zhou Y, Mohamed MF, Meerwein S, Pangan AL. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2513-2524. doi: 10.1016/S0140-6736(18)31116-4. Epub 2018 Jun 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12	The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 20% response (ACR20) at Week 12. 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 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
Primary	Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12	The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was low disease activity, based on a Disease Activity Score 28 (DAS28)-CRP score of = 3.2 at Week 12.; 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 (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.; A DAS28 score less than or equal to 3.2 indicates low disease activity.	Week 12
Secondary	Change From Baseline in in Disease Activity Score 28 (CRP) at Week 12	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 (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline in DAS28 (CRP) indicates improvement in disease activity.	Baseline and Week 12
Secondary	Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12	The Health Assessment Questionnaire - Disability Index is a patient-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.	Baseline and Week 12
Secondary	Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12	The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).; The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.	Baseline and Week 12
Secondary	Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12	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 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	Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12	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 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	Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1	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 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 1

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