A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone

Rheumatoid Arthritis Clinical Trial

— SELECT-NEXT  

Official title:

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02675426
• Other study ID #: M13-549
• Secondary ID: 2015-003332-13
• Status: Completed
• Phase: Phase 3
• Start date: December 17, 2015
• Est. completion date: March 10, 2022

Study information

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

Clinical Trial Summary

The primary objectives of this study are to compare the efficacy, safety, and tolerability of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs.

Description:

This Phase 3 multicenter study includes two periods. Period 1 is a 12-week, randomized, double-blind, parallel-group, placebo-controlled period designed to compare the safety and efficacy of upadacitinib 30 mg once daily and upadacitinib 15 mg once daily versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis (RA) who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs.

Period 2 is a 248-week blinded long-term extension period to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 30 mg once daily and upadacitinib 15 mg once daily in participants who completed Period 1.

Participants were to be randomized in a 2:2:1:1 ratio using interactive response technology (IRT) to receive double-blind study drug in one of the following treatment groups:

• Group 1: Upadacitinib 30 mg QD in Period 1 → Upadacitinib 30 mg QD in Period 2

• Group 2: Upadacitinib 15 mg QD in Period 1 → Upadacitinib 15 mg QD in Period 2

• Group 3: Placebo in Period 1 → Upadacitinib 30 mg QD in Period 2

• Group 4: Placebo in Period 1 → Upadacitinib 15 mg QD in Period 2

Randomization was stratified by prior exposure to biological disease-modifying anti-rheumatic drug (bDMARD) (yes/no) and geographic region.

Following Protocol Amendment 6.0 approval in December 2019, all participants still on study received open-label upadacitinib 15 mg QD, including those on upadacitinib 30 mg QD, with the earliest switch occurring at the Week 168 visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 661
• Est. completion date: March 10, 2022
• Est. primary completion date: April 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult male or female, at least 18 years old.

• Diagnosis of rheumatoid arthritis (RA) for greater than or equal to 3 months.

• Subjects have been receiving conventional synthetic DMARD (csDMARD) therapy for greater than or equal to 3 months and on a stable dose for greater than or equal to 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide.

• Meets the following minimum disease activity criteria: greater than or equal to 6 swollen joints (based on 66 joint counts) and greater than or equal to 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.

• Subjects with prior exposure to at most one biologic DMARD (bDMARD) may be enrolled (up to 20% of study population) if they have documented evidence of intolerance to bDMARDs or limited exposure (less than 3 months) and have satisfied required washout periods.

Exclusion Criteria:

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

• History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.

• Subjects who are considered inadequate responders to bDMARD therapy as determined by the Investigator.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
Argentina	Mautalen Salud e Investigacion /ID# 141419	Buenos Aires
Argentina	Inst. Rheumatologic Strusberg /ID# 145648	Cordoba
Australia	Emeritus Research /ID# 138773	Camberwell	Victoria
Australia	Coffs Clinical Trials /ID# 138747	Coffs Harbour	New South Wales
Australia	Barwon Rheumatology /ID# 138772	Geelong	Victoria
Australia	Optimus Clinical Research Pty. /ID# 138769	Kogarah	New South Wales
Austria	Rheuma Zentrum Favoriten GmbH /ID# 138787	Vienna
Austria	Wilhelminenspital der Stadt Wien /ID# 138788	Wien
Belgium	AZ Sint Lucas /ID# 141338	Brugge
Belgium	Rhumaconsult SPRL /ID# 138813	Charleroi	Hainaut
Belgium	UZ Gent /ID# 138806	Gent	Oost-Vlaanderen
Bosnia and Herzegovina	University Clinical Centre of the Republic of Srpska /ID# 138819	Banja Luka	Republika Srpska
Bosnia and Herzegovina	University Clinical Centre of the Republic of Srpska /ID# 140372	Banja Luka	Republika Srpska
Bulgaria	Diag Consult Ctr 17 Sofia EOOD /ID# 141006	Sofia
Bulgaria	Diagnostic Consultative Center /ID# 138882	Sofia
Canada	Groupe de Recherche en Maladies Osseuses /ID# 138906	Sainte-foy	Quebec
Canada	Dr. Latha Naik /ID# 139089	Saskatoon	Saskatchewan
Canada	Eastern Health /ID# 140431	St. John's	Newfoundland and Labrador
Canada	Manitoba Clinic /ID# 139086	Winnipeg	Manitoba
Croatia	Klinicki bolnicki centar Rijeka /ID# 138649	Rijeka	Primorsko-goranska Zupanija
Croatia	Klinicka bolnica Sveti Duh /ID# 152812	Zagreb
Croatia	Medical Center Kuna-Peric /ID# 140365	Zagreb
Croatia	Poliklinika Bonifarm /ID# 141415	Zagreb
Czechia	Revmatologie, s.r.o. /ID# 138899	Brno
Czechia	L.K.N. Arthrocentrum, s.r.o /ID# 141340	Hlucín	Moravskoslezsky Kraj
Czechia	Artroscan s.r.o. /ID# 138833	Ostrava
Czechia	Nemocnice Slany /ID# 141112	Slany
Czechia	PV-MEDICAL s.r.o. /ID# 138913	Zlin
Estonia	Paernu Hospital /ID# 138961	Pärnu
Estonia	Center of Clinical and Basic Research /ID# 141116	Tallinn	Harjumaa
Estonia	East Tallinn Central Hospital /ID# 140618	Tallinn
Finland	Helsinki Univ Central Hospital /ID# 140381	Helsinki
Finland	Kiljava Medical Research /ID# 139260	Hyvinkaa
Finland	South Karelia Central Hospital /ID# 139973	Lappeenranta
France	CHRU Tours - Hopital Trousseau /ID# 138969	Chambray Les Tours
France	Hopital Saint Joseph /ID# 149188	Marseille CEDEX 08	Bouches-du-Rhone
Germany	Charité Universitätsmedizin Campus Mitte /ID# 139052	Berlin
Germany	Immanuel-Krankenhaus /ID# 139059	Berlin
Germany	Asklepios Klinik Altona /ID# 140466	Hamburg
Germany	Uniklinik Koln /ID# 139084	Köln	Nordrhein-Westfalen
Germany	Welcker, Planegg, DE /ID# 140467	Planegg
Greece	University General Hospital of Heraklion "PA.G.N.I" /ID# 139115	Heraklion
Hong Kong	Prince of Wales Hospital /ID# 139314	Sha Tin
Hungary	Revita Reumatologiai Rendelo /ID# 140761	Budapest
Hungary	Fejer Megyei Szent Gyorgy Korh /ID# 138554	Szekesfehervar
Ireland	St Vincent's University Hosp /ID# 138562	Dublin
Italy	Universita di Catanzaro Magna Graecia /ID# 139316	Catanzaro	Calabria
Kazakhstan	JSC Nat Scientific Med Res Ctr /ID# 140575	Astana
Korea, Republic of	Daegu Catholic University Med /ID# 139249	Daegu
Korea, Republic of	Chungnam National University Hospital /ID# 138653	Daejeon
Korea, Republic of	Chonnam National University Hospital /ID# 138651	Gwangju	Jeonranamdo
Korea, Republic of	Inha University Hospital /ID# 149310	Incheon	Gwang Yeogsi
Korea, Republic of	Asan Medical Center /ID# 140579	Seoul
Korea, Republic of	Cath Univ Seoul St Mary's Hosp /ID# 138652	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Hanyang University Seoul Hospi /ID# 138655	Seoul	Seongdong-gu
Korea, Republic of	Seoul National University Hospital /ID# 138659	Seoul
Korea, Republic of	Ajou University Hospital /ID# 149311	Suwon-si	Gyeonggido
Latvia	LTD M+M Centers /ID# 138818	Adazi
Lithuania	Klaipeda University Hospital /ID# 141416	Klaipeda
Lithuania	Vilnius University Hospital /ID# 141348	Vilnius
Mexico	Centro Peninsular de Investigación Clínica SCP /ID# 148160	Colonia Centro	Yucatan
Mexico	Unidad de Investigacion de las Enfermedades Reumatologicas SA de CV /ID# 138841	Mexico City
New Zealand	Porter Rheumatology Ltd /ID# 138347	Nelson
Poland	Osteo-Medic spolka cywilna /ID# 138371	Bialystok	Podlaskie
Poland	NZOZ Centrum Reumatologiczne /ID# 138353	Elblag	Warminsko-mazurskie
Poland	McBk Sc /Id# 138360	Grodzisk Mazowiecki	Mazowieckie
Poland	NZOZ Nasz Lekarz /ID# 138374	Torun	Kujawsko-pomorskie
Poland	Rheuma Medicus /ID# 138372	Warsaw
Portugal	Centro Hospitalar Lisboa Ocidental, EPE /ID# 140594	Lisbon	Lisboa
Portugal	Instituto Portugues De Reumatologia /ID# 148315	Lisbon	Lisboa
Puerto Rico	School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 139328	San Juan
Romania	Spitalul Clinic Judetean de Urgenta /ID# 138407	Cluj
Romania	Spitalul Municipal Ploiesti /ID# 138405	Ploiesti
Romania	Spitalul Clinic Judetean de Ur /ID# 138393	Sibiu
Russian Federation	Kazan State Medical University /ID# 138413	Kazan	Tatarstan, Respublika
Russian Federation	Republican Clin Hos n.a. Baran /ID# 139273	Petrozavodsk
Russian Federation	LLC Novaya Klinika /ID# 139269	Pyatigorsk	Stavropol Skiy Kray
Russian Federation	Samara Regional Clinical Hosp /ID# 148642	Samara
Russian Federation	Ulyanovsk Regional Clin Hosp /ID# 139279	Ulyanovsk
Russian Federation	Voronezh State Medical Univers /ID# 148431	Voronezh
Russian Federation	Yaroslavi State Medical Univer /ID# 139908	Yaroslavl
Slovakia	ARTROMAC n.o. /ID# 138428	Kosice
Slovakia	Nemocnica Kosice Saca, a.s. /ID# 138918	Kosice
Slovakia	Narodny ustav reumatickych chorob Piestany /ID# 138427	Pieštany
Slovakia	Slovak research center Team Member, Thermium s.r.o. /ID# 139924	Pieštany
Slovakia	REUMA-GLOBAL, s.r.o. /ID# 139912	Trnava
South Africa	St. Augustine's Medical Centre /ID# 141352	Berea	Kwazulu-Natal
South Africa	Arthritis Clinical Research Tr /ID# 138945	Cape Town	Western Cape
South Africa	Winelands Medical Research Ctr /ID# 138944	Stellenbosch	Western Cape
Spain	Hospital General Univ de Elche /ID# 138991	Elche
Spain	Hospital Clin Univ San Carlos /ID# 138993	Madrid
Spain	Hospital Regional de Malaga /ID# 138975	Málaga	Malaga
Spain	Hosp Nuestra Senora Esperanza /ID# 138997	Santiago de Compostela
Switzerland	HFR Fribourg - Hopital Canton /ID# 139155	Fribourg
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 140869	Kaohsiung
Taiwan	Far Eastern Memorial Hospital /ID# 140871	New Taipei City
Taiwan	China Medical University Hosp /ID# 139232	Taichung City	Taichung
Taiwan	National Cheng Kung University Hospital /ID# 140868	Tainan City	Tainan
Taiwan	National Taiwan Univ Hosp /ID# 141443	Taipei City	Taipei
Taiwan	Taipei Veterans General Hosp /ID# 139234	Taipei City
Turkey	Ankara Numune Training and Res /ID# 139237	Ankara
Ukraine	LLC Revmocentr /ID# 139872	Kyiv
Ukraine	MNCE "Lviv City Clinical Hospital #4" /ID# 139873	Lviv
Ukraine	Odessa National Medical Univ /ID# 139179	Odesa
United Kingdom	Western General Hospital /ID# 139524	Edinburgh
United Kingdom	Leicester Royal Infirmary /ID# 139184	Leicester	England
United Kingdom	The Royal Free Hospital /ID# 139191	London	London, City Of
United Kingdom	Whipps Cross Univ Hospital /ID# 139523	London	London, City Of
United Kingdom	Southampton General Hospital /ID# 139169	Southampton
United Kingdom	Warrington + Halton Hosp NHS /ID# 139195	Warrington
United States	The Center for Rheumatology /ID# 138746	Albany	New York
United States	Tekton Research, Inc. /ID# 141428	Austin	Texas
United States	Western Washington Arthritis C /ID# 138728	Bothell	Washington
United States	Trinity Universal Res Assoc /ID# 149271	Carrollton	Texas
United States	Cincinnati Rheumatic Disease Study Group, Inc. /ID# 138868	Cincinnati	Ohio
United States	Clinical Res of West FL, Inc. /ID# 138854	Clearwater	Florida
United States	Arth and Osteo Clin Brazo Valley /ID# 147809	College Station	Texas
United States	Covina Arthritis Clinic /ID# 139881	Covina	California
United States	Metroplex Clinical Research /ID# 138698	Dallas	Texas
United States	Denver Arthritis Clinic /ID# 139876	Denver	Colorado
United States	Altoona Ctr Clinical Res /ID# 138741	Duncansville	Pennsylvania
United States	T. Joseph Raoof, MD, Inc. /ID# 140964	Encino	California
United States	Aurora Rheumatology and Immunotherapy Center /ID# 139306	Franklin	Wisconsin
United States	Comprehensive Arthritis Care, a division of Comprehensive Rheumatology Care PLLC /ID# 141021	Hendersonville	Tennessee
United States	Baylor College of Medicine /ID# 138682	Houston	Texas
United States	Houston Institute for Clin Res /ID# 138716	Houston	Texas
United States	Institute of Arthritis Res /ID# 138548	Idaho Falls	Idaho
United States	Indiana Univ School of Med /ID# 140077	Indianapolis	Indiana
United States	Arthritis Consultants, P.A. /ID# 141138	Killeen	Texas
United States	Allergy and Rheum Med Clin /ID# 146082	La Jolla	California
United States	Advanced Rheumatology, PC /ID# 140071	Lansing	Michigan
United States	Justus J. Fiechtner, MD, PC /ID# 138697	Lansing	Michigan
United States	Bluegrass Community Research /ID# 138295	Lexington	Kentucky
United States	Physician Res. Collaboration /ID# 138533	Lincoln	Nebraska
United States	Pacific Arthritis Ctr Med Grp /ID# 138744	Los Angeles	California
United States	Mansfield Health Center /ID# 141357	Mansfield	Massachusetts
United States	AZ Arthritis and Rheum Assoc /ID# 148651	Mesa	Arizona
United States	Ctr Arthritis & Rheumatic Dise /ID# 141696	Miami	Florida
United States	Medallion Clinical Research Institute, LLC /ID# 140074	Naples	Florida
United States	Suncoast Clinical Research /ID# 138633	New Port Richey	Florida
United States	Health Research Oklahoma /ID# 138535	Oklahoma City	Oklahoma
United States	Westroads Clinical Research /ID# 138304	Omaha	Nebraska
United States	Omega Research Consultants /ID# 139877	Orlando	Florida
United States	Four Rivers Clinical Research /ID# 141134	Paducah	Kentucky
United States	Arthritis Center, Inc. /ID# 141363	Palm Harbor	Florida
United States	SunValley Arthritis Center, Lt /ID# 140452	Peoria	Arizona
United States	Arizona Research Center, Inc. /ID# 140448	Phoenix	Arizona
United States	AZ Arthritis & Rheuma Research /ID# 138598	Phoenix	Arizona
United States	AZ Arthritis and Rheum Researc /ID# 138500	Phoenix	Arizona
United States	AZ Arthritis and Rheum Researc /ID# 139286	Phoenix	Arizona
United States	Trinity Universal Research Association /ID# 148649	Plano	Texas
United States	MMP Women's Health /ID# 141542	Portland	Maine
United States	OrthoIllinois /ID# 139695	Rockford	Illinois
United States	PMG Research of Salisbury /ID# 141023	Salisbury	North Carolina
United States	Accurate Clinical Management /ID# 139338	San Antonio	Texas
United States	Clinical Investigation Special /ID# 139696	Skokie	Illinois
United States	Arthritis Northwest, PLLC /ID# 138539	Spokane	Washington
United States	Springfield Clinic /ID# 138602	Springfield	Illinois
United States	Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 138689	Summerville	South Carolina
United States	Arthritis Assoc of NW Ohio /ID# 140953	Toledo	Ohio
United States	University of Arizona Cancer Center - North Campus /ID# 140451	Tucson	Arizona
United States	Robin K. Dore MD, Inc /ID# 138688	Tustin	California
United States	Inland Rheum Clin Trials Inc. /ID# 138853	Upland	California
United States	Deerbrook Medical Associates /ID# 139694	Vernon Hills	Illinois
United States	Arthritis & Osteoporosis Clinic /ID# 138703	Waco	Texas
United States	The Center for Rheumatology & /ID# 139203	Wheaton	Maryland
United States	PMG Research of Wilmington LLC /ID# 140951	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Bosnia and Herzegovina,  Bulgaria,  Canada,  Croatia,  Czechia,  Estonia,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Ireland,  Italy,  Kazakhstan,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  New Zealand,  Poland,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  Slovakia,  South Africa,  Spain,  Switzerland,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

References & Publications (1)

Burmester GR, Kremer JM, Van den Bosch F, Kivitz A, Bessette L, Li Y, Zhou Y, Othman AA, Pangan AL, Camp HS. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. 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), 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), 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 Summary (PCS) Score 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 summary 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 Achieving Clinical Remission Based on DAS28 (CRP) at Week 12	Clinical remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than 2.6.; 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 (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.	Week 12
Secondary	Percentage of Participants Achieving Low Disease Activity Based on CDAI at Week 12	Low disease activity based on the clinical disease activity index (CDAI) is defined as a CDAI score = 10.; 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 global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.	Week 12
Secondary	Change From Baseline in Duration of Morning Stiffness at Week 12	Participants were asked to indicate the time it took for them to get as limber as possible after awakening with morning stiffness over the past 7 days.	Baseline and Week 12
Secondary	Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 12	The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a five point Likert scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from Baseline indicates 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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