A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD)

Psoriatic Arthritis Clinical Trial

— SELECT - PsA 1  

Official title:

A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) - SELECT - PsA 1

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03104400
• Other study ID #: M15-572
• Secondary ID: 2016-004130-24
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 27, 2017
• Est. completion date: August 29, 2024

Study information

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

Clinical Trial Summary

This study includes two periods. The main objective of Period 1 is to compare the efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo and versus adalimumab (Humira®) in participants with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response to non-biologic DMARDs (DMARD-IR). Period 1 is also designed to compare the efficacy of upadacitinib 15 mg and 30 mg QD versus placebo for the prevention of structural progression.

The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg and 30 mg QD in participants who have completed Period 1.

Description:

The study includes a 35-day screening period, a 56-week blinded period (Period 1), a long-term extension period of up to a total treatment duration of approximately 5 years (Period 2), a 30-day follow-up call or visit, and a 70-day follow-up call.

Period 1 includes 24 weeks of randomized, double-blind, placebo-controlled and active comparator-controlled treatment followed by 32 weeks of active comparator-controlled upadacitinib; at Week 24 participants assigned to placebo will be switched to upadacitinib according to their randomization assignment.

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

• Group 1: Upadacitinib 15 mg QD

• Group 2: Upadacitinib 30 mg QD

• Group 3: Adalimumab 40 mg every other week (EOW)

• Group 4: Placebo followed by upadacitinib 15 mg QD

• Group 5: Placebo followed by upadacitinib 30 mg QD

Randomization will be stratified by extent of psoriasis (≥ 3% body surface area [BSA] or < 3% BSA), current use of at least 1 non-biologic DMARD, presence of dactylitis, and presence of enthesitis, except for participants from China and Japan, where randomization for each country will be stratified by extent of psoriasis (≥ 3% BSA or < 3% BSA) only.

Participants who complete the Week 56 visit (end of Period 1) will enter the long-term extension portion of the study, Period 2 (total treatment up to approximately 5 years), and continue study treatment as assigned in Period 1 in a blinded manner until the last subject completes the last visit of Period 1 (Week 56), when study drug assignment in both periods will be unblinded and participants will be dispensed study drug in an open-label fashion until the completion of Period 2.

At Week 16, rescue therapy will be offered to participants classified as non-responders (defined as not achieving at least 20% improvement in tender joint count (TJC) and / or swollen joint count (SJC) at both Week 12 and Week 16). Starting at Week 36, participants who fail to demonstrate at least 20% improvement in either or both TJC and SJC compared to Baseline at 2 consecutive visits will be discontinued from study drug treatment. Additionally, in participants continuing on study drug, starting at the Week 36 visit, initiation of or change in background PsA medication(s) is allowed as per local label.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1705
• Est. completion date: August 29, 2024
• Est. primary completion date: September 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) criteria.

• Participant has active disease at Baseline defined as >= 3 tender joints (based on 68 joint counts) and >= 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits.

• Presence of either at Screening:

1. >= 1 erosion on x-ray as determined by central imaging review or;

2. high-sensitivity C-reactive protein (hs-CRP) > laboratory defined upper limit of normal (ULN).

• Diagnosis of active plaque psoriasis or documented history of plaque psoriasis.

• Participant has had an inadequate response (lack of efficacy after a minimum 12 week duration of therapy) to previous or current treatment with at least 1 non-biologic DMARD at maximally tolerated dose (methotrexate (MTX), sulfasalazine (SSZ), leflunomide (LEF), cyclosporine, apremilast, bucillamin or iguratimod), or participant has an intolerance to or contraindication for DMARDs as defined by the investigator.

• Participant who is on current treatment with concomitant non-biologic DMARDs at study entry must be on <= 2 non-biologic DMARDs (except the combination of MTX and leflunomide). The following non-biologic DMARDs are allowed: MTX, sulfasalazine, leflunomide, apremilast, hydroxychloroquine (HCQ) , bucillamine or iguratimod, and have been ongoing for >= 12 weeks and at stable dose for >= 4 weeks prior to the Baseline Visit. No other DMARDs are permitted during the study.

i. Participants who need to discontinue DMARDs prior to the Baseline Visit to comply with this inclusion criterion must follow the procedure specified below or at least five times the mean terminal elimination half-life of a drug:

1. >= 8 weeks for LEF if no elimination procedure was followed, or adhere to an elimination procedure (i.e., 11 days with cholestyramine, or 30 days washout with activated charcoal or as per local label);

2. >= 4 weeks for all others.

Exclusion Criteria:

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

• Current treatment with > 2 non-biologic DMARDs; or use of DMARDs other than methotrexate, sulfasalazine, leflunomide, apremilast, hydroxychloroquine, bucillamine, or iguratimod; or use of methotrexate in combination with leflunomide.

• History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than PsA (including, but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus). Prior history of reactive arthritis or axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritis is permitted if documentation of change in diagnosis to PsA or additional diagnosis of PsA is made. Prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis
• Rheumatic Diseases

Intervention

Drug:
• Adalimumab
Administered by subcutaneous injection
• Upadacitinib
Oral tablet
• Placebo to Upadacitinib
Oral tablet
• Placebo to Adalimumab
Administered by subcutaneous injection

Locations

Country	Name	City	State
Argentina	Hospital General de Agudos Ram /ID# 164378	Buenos Aires
Argentina	Organizacion Medica de Investigacion (OMI) /ID# 160118	Buenos Aires
Argentina	Psoriahue Med Interdisciplinar /ID# 160506	Buenos Aires
Argentina	Inst. de Rehab. Psicofisica /ID# 165154	Caba
Argentina	Instituto CAICI /ID# 160119	Rosario, Santa FE
Argentina	Centro Integral de Medicina Respiratoria (CIMER) /ID# 211237	San Miguel de Tucuman	Tucuman
Argentina	Centro Medico Privado/Reuma /ID# 159775	San Miguel de Tucuman	Ciuadad Autonoma De Buenos Aires
Argentina	Centro Integral de Medicina Re /ID# 160258	SAN Miguel DE Tucuman, Latam
Argentina	Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 165795	Santa Fe
Australia	Emeritus Research Sydney /ID# 166780	Botany	New South Wales
Australia	Barwon Rheumatology /ID# 166782	Geelong	Victoria
Australia	Heidelberg Repatriation Hospital /ID# 167450	Heidelberg West	Victoria
Australia	The Queen Elizabeth Hospital /ID# 169333	Woodville	South Australia
Belarus	Brest Regional Hospital /ID# 164535	Brest
Belarus	Healthcare Institution /ID# 164536	Grodno
Belarus	First City Clinical Hospital /ID# 164534	Minsk
Belgium	Reuma clinic /ID# 164243	Genk
Bosnia and Herzegovina	University Clinical Centre of the Republic of Srpska /ID# 164503	Banja Luka	Republika Srpska
Bosnia and Herzegovina	University Clinical Hospital Mostar /ID# 165799	Mostar
Bosnia and Herzegovina	Clinical Center University of Sarajevo /ID# 164502	Sarajevo
Brazil	Instituto de Ciencias Farmacêuticas /ID# 163274	Aparecida de Goiania	Goias
Brazil	EDUMED Educacao em Saude S/S L /ID# 161816	Curitiba	Parana
Brazil	CIP - Centro Internacional de Pesquisa /ID# 161821	Goiânia	Goias
Brazil	CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 161819	Juiz de Fora	Minas Gerais
Brazil	Hospital de Clinicas de Porto Alegre /ID# 161820	Porto Alegre	Rio Grande Do Sul
Brazil	Instituto de Educação e Pesquisa do Hospital Moinhos de Vento /ID# 161813	Porto Alegre	Rio Grande Do Sul
Brazil	LMK Sevicos Medicos S/S /ID# 161812	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 163273	Ribeirao Preto	Sao Paulo
Brazil	CEMEC - Centro Multidisciplinar de Estudos Clínicos do ABC /ID# 161810	Santo André	Sao Paulo
Brazil	Faculdade de Medicina do ABC /ID# 163491	Santo André	Sao Paulo
Brazil	CPCLIN - Centro de Pesquisas Clínicas /ID# 161818	Sao Paulo
Bulgaria	Department of Rheumatology, Mu /ID# 169606	Plovdiv
Bulgaria	Excelsior Medical Center /ID# 169609	Sofia
Bulgaria	Medical Centre Synexus Sofia /ID# 202394	Sofia
Bulgaria	Multiprofile Hospital for Active Treatment - Sofia at Military Medical Academy /ID# 169608	Sofia
Bulgaria	UMHAT Sv. Ivan Rilski /ID# 202393	Sofia
Bulgaria	Medical Centre Synexus Sofia, branch Stara Zagora /ID# 202524	Stara Zagora
Bulgaria	Diagnostic Consultative Center /ID# 169607	Varna
Canada	The Waterside Clinic /ID# 157826	Barrie	Ontario
Canada	Groupe de Recherche en Maladies Osseuses Inc /ID# 157824	Sainte-foy	Quebec
Canada	Ctr. de Recherche Musculo-Sque /ID# 207069	Trois-rivières	Quebec
Canada	Percuro Clinical Research, Ltd /ID# 157823	Victoria	British Columbia
Canada	Ciads /Id# 157831	Winnipeg	Manitoba
Canada	Manitoba Clinic /ID# 157829	Winnipeg	Manitoba
Chile	M y F Estudios Clínicos Ltda. /ID# 168722	Ñuñoa	Region Metropolitana De Santiago
Chile	CTR Estudios SpA /ID# 206217	Providencia
Chile	Centro Inter Estud Clin CIEC /ID# 168725	Santiago
Chile	Prosalud Ltda. /ID# 169546	Santiago
Chile	Clinica Dermacross S.A /ID# 168726	Vitacura Santiago
China	The First Affiliated Hospital of Baotou Medical College, Inner Monggolia Univers /ID# 171204	Baotou	Inner Mongolia
China	Peking University Third Hospital /ID# 201973	Beijing	Beijing
China	1st Aff Hosp of Bengbu Medical College /ID# 201021	Bengbu	Anhui
China	West China Hospital /ID# 200199	Chengdu	Sichuan
China	The Aff Hosp Inner Mongolia /ID# 207787	Huhehaote
China	First Affiliated Hospital of Kunming Medical University /ID# 201264	Kunming
China	The First People's Hospital of Linyi /ID# 201970	Linyi	Shandong
China	Affiliated hospital of nantong university /ID# 208234	Nantong
China	Ningbo First Hospital /ID# 201874	Ningbo	Zhejiang
China	Huashan Hospital of Fudan University /ID# 202191	Shanghai	Shanghai
China	Shanghai Changhai Hospital /ID# 200202	Shanghai	Shanghai
China	The First Affiliated Hospital of Shantou University Medical College /ID# 203371	Shantou	Guangdong
China	The First Affiliated Hospital of Soochow University /ID# 201875	Soochow
China	People's Hospital of Xinjiang /ID# 201592	Urumqi
China	Zhuzhou Central Hospital /ID# 200201	Zhuzhou	Hunan
Colombia	Fundacion Centro de Investigac /Id# 168201	Antioquia
Colombia	Ctr Int de Reum del Caribe SAS /ID# 164051	Barranquilla
Colombia	Centro de Investigacion en Reumatologia CIREEM /ID# 166030	Bogota	Cundinamarca
Colombia	Preventive Care Sas /Id# 163781	Chia
Colombia	Hospital Pablo Tobon Uribe /ID# 164233	Medellín
Croatia	Klinicki bolnicki centar Rijeka /ID# 161159	Rijeka	Primorsko-goranska Zupanija
Croatia	Medical Center Kuna-Peric /ID# 161160	Zagreb
Croatia	Poliklinika Bonifarm /ID# 206662	Zagreb
Croatia	Poliklinika Repromed /ID# 203555	Zagreb	Grad Zagreb
Czechia	Revmatologie Bruntal, s.r.o /ID# 159636	Bruntál
Czechia	Artroscan s.r.o. /ID# 159634	Ostrava
Czechia	Revmatologicka ambulance /ID# 159637	Prague 4	Praha 4
Czechia	Revmatologicka ambulance /ID# 159671	Prague 4	Praha 4
Czechia	Medical Plus, s.r.o. /ID# 159635	Uherské Hradište
Estonia	Center of Clinical and Basic Research /ID# 163870	Tallinn	Harjumaa
Estonia	East Tallinn Central Hospital /ID# 163790	Tallinn
Estonia	MediTrials /ID# 163706	Tartu	Tartumaa
Germany	Immanuel-Krankenhaus /ID# 163931	Berlin-buch
Germany	University Clinic Carl Gustav /ID# 163926	Dresden
Germany	Polikilinik fuer Rheumatologie /ID# 163933	Duesseldorf
Germany	Cent fur Innovative Diagnostik /ID# 163927	Frankfurt
Germany	Hamburger Rheuma Forschungszentrum II im MVZ Rheumatologie und Autoimmunmedizin /ID# 204421	Hamburg
Germany	Rheumazentrum Ruhrgebiet /ID# 163930	Herne	Nordrhein-Westfalen
Germany	Dr. med. Jochen Walter FA fuer /ID# 168638	Rendsburg
Germany	Med. Universitaetsklinik Inner /ID# 163929	Tuebingen
Greece	General Hospital of Athens Laiko /ID# 163476	Athens	Attiki
Greece	General Hospital of Athens Laiko /ID# 163478	Athens	Attiki
Greece	Naval Hospital of Athens /ID# 163486	Athens
Greece	University General Hospital Attikon /ID# 163477	Athens	Attiki
Greece	University General Hospital of Heraklion PA.G.N.I /ID# 163472	Heraklion
Greece	Reg Gen Univ Hosp Larissa /ID# 163496	Larisa
Hong Kong	Prince of Wales Hospital /ID# 163506	Hong Kong
Hong Kong	Queen Mary Hospital /ID# 162492	Hong Kong
Hong Kong	Tuen Mun Hospital /ID# 162493	Tuen Mun
Hungary	Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz /ID# 170719	Budapest
Hungary	Obudai Egeszsegugyi Centrum Kft. /ID# 163279	Budapest
Hungary	Revita Reumatologiai Rendelo /ID# 163277	Budapest
Hungary	Synexus Magyarorszag Kft. /ID# 203012	Budapest
Hungary	Qualiclinic Kft. /ID# 163278	Budapest III	Pest
Hungary	Debreceni Egyetem Kenezy Gyula /ID# 163276	Debrecen
Hungary	Synexus Magyarorszag Kft. - Gyula DRS /ID# 202209	Gyula	Bekes
Hungary	Szabolcs-Szatmar-Bereg Megyei Korhazak & Egyetemi Oktatok.- Klinikai Kutatasi O. /ID# 202584	Nyíregyháza	Szabolcs-Szatmar-Bereg
Hungary	Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 163275	Veszprem
Hungary	Synexus Magyarorszag Kft. - Zalaegerszeg AS /ID# 201884	Zalaegerszeg	Zala
Ireland	St Vincent's University Hosp /ID# 161073	Dublin
Ireland	Croom Orthopaedic Hospital /ID# 164998	Limerick
Israel	The Lady Davis Carmel MC /ID# 170262	Haifa
Israel	Sheba Medical Center /ID# 202532	Ramat Gan
Israel	Tel Aviv Sourasky Medical Center /ID# 169845	Tel Aviv-Yafo	Tel-Aviv
Italy	Ospedali Riuniti Universita /ID# 161085	Ancona
Italy	Azienda Ospedaliera Universitaria Policlinico "G. Rodolico - San Marco" /Id# 161084	Catania
Italy	AOU Federico II /ID# 202411	Naples	Campania
Italy	Azienda Unita Sanitaria Locale/IRCCS c/o Arcispedale Santa Maria Nuova /ID# 161090	Reggio Emilia	Emilia-Romagna
Italy	Policlinico Universitario Campus Bio-Medico /ID# 162306	Rome	Lazio
Japan	St.Luke's International Hospital /ID# 162016	Chuo-ku	Tokyo
Japan	Fukuoka University Hospital /ID# 162086	Fukuoka-shi	Fukuoka
Japan	National Hospital Organization Osaka Minami Medical Center /ID# 162590	Kawachinagano-shi	Osaka
Japan	Hospital of the University of Occupational and Environmental Health /ID# 161473	Kitakyushu-shi	Fukuoka
Japan	Nagoya City University Hospital /ID# 162564	Nagoya-shi	Aichi
Japan	Mie University Hospital /ID# 162080	Tsu-shi	Mie
Korea, Republic of	Inha University Hospital /ID# 163890	Jung-gu	Incheon Gwang Yeogsi
Korea, Republic of	Ajou University Hospital /ID# 163891	Suwon-si	Gyeonggido
Latvia	M &M Centrs /Id# 161483	Adazi
Latvia	D.Saulites-Kandevicas PP in Cardiology and Rheumatology /ID# 161488	Liepaja
Latvia	Clinic ORTO /ID# 161486	Riga
Latvia	P. Stradins Clinical Univ Hosp /ID# 164442	Riga
Lithuania	VAKK dr. Kildos Clinic /ID# 167257	Kaunas
Lithuania	Klaipeda University Hospital /ID# 167258	Klaipeda
Lithuania	Public Institution Republican /ID# 165155	Siauliai
Lithuania	Vilnius University Hospital /ID# 165123	Vilnius
Malaysia	Hospital Raja Permaisuri Bainun /ID# 161099	Ipoh	Perak
Malaysia	Hospital Tuanku Ja afar /ID# 161096	Seremban
Mexico	Invest y Biomed de Chihuahua /ID# 164007	Chihuahua
Mexico	Instituto Jalisciense de Metabolismo SC /ID# 164005	Guadalajara	Jalisco
Mexico	CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 164006	Mexico City	Ciudad De Mexico
Netherlands	Medisch Centrum Leeuwarden /ID# 161575	Leeuwarden
Netherlands	Erasmus Medisch Centrum /ID# 161092	Rotterdam
Netherlands	Maasstad Ziekenhuis /ID# 160168	Rotterdam
New Zealand	Middlemore Hospital /ID# 166414	Auckland
New Zealand	North Shore Hospital /ID# 169409	Auckland
New Zealand	Waikato Hospital /ID# 166415	Hamilton	Waikato
New Zealand	Porter Rheumatology Ltd /ID# 200421	Nelson
New Zealand	Timaru Rheumatology Studies /ID# 166413	Timaru
Norway	Helse Forde /ID# 167853	Forde	Sogn Og Fjordane
Norway	St. Olavs Hospital HF /ID# 163321	Trondheim	Sor-Trondelag
Poland	Malopolskie Centrum Kliniczne /ID# 163777	Cracow	Malopolskie
Poland	Centrum Kliniczno-Badawcze /ID# 161830	Elblag
Poland	Synexus Polska Sp. z o.o. Oddzial w Gdansku /ID# 206299	Gdansk	Pomorskie
Poland	Synexus Polska Sp. z o.o. Oddzial w Gdyni /ID# 207157	Gdynia	Pomorskie
Poland	Synexus Polska Sp. z o.o. Oddzial Katowice /ID# 204510	Katowice	Slaskie
Poland	Krakowskie Centrum Medyczne /ID# 206302	Krakow
Poland	Salve Medica Sp. z o.o. S.K. /ID# 206300	Lodz	Lodzkie
Poland	ETYKA-Osrodek Badan Klinicznyc /ID# 163776	Olsztyn	Warminsko-mazurskie
Poland	Synexus Polska Sp. z o.o. Oddzial w Poznaniu /ID# 207158	Poznan
Poland	NZOZ Nasz Lekarz /ID# 163774	Torun	Kujawsko-pomorskie
Poland	Medycyna Kliniczna /ID# 166288	Warsaw
Poland	Reumatika - Centrum Reumatologii NZOZ /ID# 161831	Warsaw
Poland	Synexus Polska Sp. z.o.o. /ID# 203987	Warsaw
Poland	Synexus Polska Sp. z o.o. /ID# 204506	Wroclaw	Dolnoslaskie
Portugal	Centro Hospitalar Lisboa Norte, EPE /ID# 165860	Lisboa
Portugal	Centro Hospitalar Lisboa Ocidental, EPE /ID# 165861	Lisbon	Lisboa
Portugal	Hospital CUF Descobertas /ID# 165866	Lisbon
Portugal	Instituto Portugues De Reumatologia /ID# 165858	Lisbon	Lisboa
Portugal	Hospital Beatriz Angelo /ID# 165865	Loures
Portugal	Unidade Local De Saude Do Alto Minho /ID# 165863	Viana Do Castelo
Portugal	Centro Hospitalar de Vila Nova Gaia/Espinho, EPE /ID# 165862	Vila Nova De Gaia	Porto
Puerto Rico	Cruz-Santana, Carolina, PR /ID# 163307	Carolina
Puerto Rico	Ponce Medical School Foundation /ID# 163920	Ponce
Puerto Rico	GCM Medical Group, PSC /ID# 162160	San Juan
Russian Federation	Kazan State Medical University /ID# 164531	Kazan	Tatarstan, Respublika
Russian Federation	Family Outpatient clinic#4 LLC /ID# 164530	Korolev	Moskva
Russian Federation	Moscow S.P.Botkin City Clinica /ID# 164533	Moscow
Russian Federation	LLC Medical Center /ID# 164529	Novosibirsk	Novosibirskaya Oblast
Russian Federation	State budgetary institution /ID# 164532	St. Petersburg
Serbia	Institute for Rheumatology /ID# 166217	Belgrade	Beograd
Serbia	Institute for Rheumatology /ID# 166223	Belgrade	Beograd
Serbia	Institute for Rheumatology /ID# 166229	Belgrade	Beograd
Serbia	Institute for Rheumatology /ID# 166231	Belgrade	Beograd
Serbia	Military Medical Academy /ID# 166293	Belgrade	Beograd
Singapore	Singapore General Hospital /ID# 161094	Singapore	Central Singapore
Singapore	Tan Tock Seng Hospital /ID# 161095	Singapore
Slovakia	MEDMAN s.r.o. /ID# 165892	Martin
Slovakia	Reumatologická ambulancia Reum.hapi s.r.o. /ID# 166486	Nové Mesto Nad Váhom
Slovakia	Slovak research center Team Member, Thermium s.r.o. /ID# 166489	Pieštany
Slovenia	Univ Medical Ctr Ljubljana /ID# 164212	Ljubljana
Slovenia	University Medical Ctr Maribor /ID# 169260	Maribor
Slovenia	General Hospital Murska Sobota /ID# 164211	Murska Sobota
South Africa	Arthritis Clinical Research Tr /ID# 163855	Cape Town	Western Cape
South Africa	Wits Clinical Research Site /ID# 163919	Johannesburg	Gauteng
South Africa	Greenacres Hospital /ID# 164190	Port Elizabeth	Eastern Cape
South Africa	Jakaranda Hospital /ID# 164242	Pretoria	Gauteng
South Africa	University of Pretoria /ID# 163852	Pretoria	Gauteng
South Africa	Winelands Medical Research Ctr /ID# 163853	Stellenbosch	Western Cape
Spain	Hospital Universitario A Coruña - CHUAC /ID# 161129	A Coruña	A Coruna
Spain	Hospital Campus de la Salud /ID# 170760	Granada
Spain	Hospital Universitario 12 de Octubre /ID# 163198	Madrid
Spain	Hospital Universitario Ramon y Cajal /ID# 161130	Madrid
Switzerland	HFR Fribourg - Hopital Canton /ID# 162090	Fribourg
Switzerland	Kantonsspital St. Gallen /ID# 158131	St. Gallen	Sankt Gallen
Taiwan	Chung Shan Medical University /ID# 159403	Taichung
Taiwan	China Medical University Hosp /ID# 159402	Taichung City	Taichung
Taiwan	National Taiwan University Hospital /ID# 160878	Taipei City
Taiwan	Taipei Veterans General Hosp /ID# 166222	Taipei City
Taiwan	Linkou Chang Gung Memorial Ho /ID# 166221	Taoyuan City
Turkey	Bakirkoy Dr. Sadi Konuk Training & Research Hospital /ID# 162517	Istanbul
Turkey	Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 163383	Istanbul
Turkey	Necmettin Erbakan Universitesi /ID# 163382	Meram Konya
Turkey	Sakarya Universitesi Egitim /ID# 163397	Sakarya
Turkey	Cukurova Universitesi Tip Fakultesi /ID# 162516	Saricam Adana	Adana
Turkey	Hacettepe Universitesi Tip Fak /ID# 162518	Sihhiye	Ankara
Ukraine	Kharkiv Regional Council Regional Clinical Hospital /ID# 210189	Kharkiv
Ukraine	State Institution L. T. Malaya Therapy National Institution of NAMS of Ukraine /ID# 164170	Kharkiv	Kharkivska Oblast
Ukraine	NSC Strazhesko Ist Cardiology /ID# 164043	Kiev
Ukraine	Kyiv Railway Clinical Hosp No.2 /ID# 208951	Kyiv
Ukraine	LLC Revmocentr /ID# 164177	Kyiv
Ukraine	Med Ctr of Private High Ed Ins /ID# 208527	Kyiv
Ukraine	Medical Center of LLC Medbud-Clinic /ID# 208528	Kyiv
Ukraine	MNI KRC Kyiv Regional Clinical Hospital /ID# 210188	Kyiv
Ukraine	Lviv Regional Clinical Hospita /ID# 164178	Lviv	Lvivska Oblast
Ukraine	Odessa National Medical Univ /ID# 164244	Odesa
Ukraine	Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 164245	Vinnytsia
United Kingdom	Christchurch Hospital /ID# 162702	Christchurch
United Kingdom	UH Coventry & Warwickshire /ID# 162701	Coventry
United Kingdom	Glasgow Royal Infirmary /ID# 162703	Glasgow
United Kingdom	Guy's and St Thomas' NHS Found /ID# 161065	London	London, City Of
United Kingdom	Whipps Cross Univ Hospital /ID# 161055	London	London, City Of
United Kingdom	Luton & Dunstable University Hospital /ID# 162704	Luton
United States	Univ of Michigan Hospitals /ID# 164014	Ann Arbor	Michigan
United States	Arthritis Clinic of N. VA, P.C /ID# 159849	Arlington	Virginia
United States	Johns Hopkins University /ID# 167665	Baltimore	Maryland
United States	Accurate Clinical Management /ID# 159905	Baytown	Texas
United States	Diagnostic Group Integrated He /ID# 159794	Beaumont	Texas
United States	Tufts Medical Center /ID# 165144	Boston	Massachusetts
United States	Graves Gilbert Clinic /ID# 161285	Bowling Green	Kentucky
United States	American Health Research /ID# 164354	Charlotte	North Carolina
United States	DJL Clinical Research, PLLC /ID# 161390	Charlotte	North Carolina
United States	Ctr for Arth and Rheum Disease /ID# 159830	Chesapeake	Virginia
United States	Great Lakes Clinical Trials /ID# 163435	Chicago	Illinois
United States	Clinical Res of West FL, Inc. /ID# 159829	Clearwater	Florida
United States	MetroHealth Medical Center /ID# 159888	Cleveland	Ohio
United States	Arth and Osteo Clin Brazo Valley /ID# 163436	College Station	Texas
United States	PCCR Solution /ID# 205723	Colleyville	Texas
United States	The Ohio State University /ID# 159892	Columbus	Ohio
United States	Adriana Pop-Moody MD Clinic PA /ID# 159984	Corpus Christi	Texas
United States	Covina Arthritis Clinic /ID# 159891	Covina	California
United States	Klein & Associates, M.D., P.A. /ID# 164013	Cumberland	Maryland
United States	Metroplex Clinical Research /ID# 159785	Dallas	Texas
United States	International Medical Research - Daytona /ID# 160040	Daytona Beach	Florida
United States	Omega Research Maitland, LLC /ID# 164193	DeBary	Florida
United States	Denver Arthritis Clinic /ID# 159873	Denver	Colorado
United States	St. Luke's Hospital of Duluth /ID# 165671	Duluth	Minnesota
United States	Altoona Ctr Clinical Res /ID# 159852	Duncansville	Pennsylvania
United States	M3-Emerging Medical Research, LLC /ID# 161391	Durham	North Carolina
United States	Arthritis and Rheum Clin N. CO /ID# 160039	Fort Collins	Colorado
United States	Aurora Rheumatology and Immunotherapy Center /ID# 160043	Franklin	Wisconsin
United States	Arthritis and Osteoporosis Associates /ID# 159802	Freehold	New Jersey
United States	St. Joseph Heritage Healthcare /ID# 159980	Fullerton	California
United States	Aa Mrc Llc /Id# 159846	Grand Blanc	Michigan
United States	Physicians East, PA /ID# 159872	Greenville	North Carolina
United States	C.V. Mehta MD, Med Corporation /ID# 161216	Hemet	California
United States	"DMCR-Texas Cent for Drug Dev /ID# 164191	Houston	Texas
United States	Rheumatic Disease Clin Res Ctr /ID# 161240	Houston	Texas
United States	Rheumatology Clinic of Houston /ID# 161234	Houston	Texas
United States	Care Access Research, Huntingt /ID# 160038	Huntington Beach	California
United States	Rheum Assoc of North Alabama /ID# 163231	Huntsville	Alabama
United States	Institute of Arthritis Researc /ID# 165873	Idaho Falls	Idaho
United States	West Tennessee Research Inst /ID# 159871	Jackson	Tennessee
United States	Glacier View Research Institut /ID# 167023	Kalispell	Montana
United States	Rheumatology Consultants, PLLC /ID# 159796	Knoxville	Tennessee
United States	Kotha and Kotha /ID# 159823	La Mesa	California
United States	TriWest Research Associates- La Mesa /ID# 159887	La Mesa	California
United States	Arthritis & Osteo Medical Ctr /ID# 166760	La Palma	California
United States	NYU Langone Rheum Assoc /ID# 159985	Lake Success	New York
United States	Colorado Arthritis Associates /ID# 159847	Lakewood	Colorado
United States	Advanced Rheumatology, PC /ID# 159893	Lansing	Michigan
United States	Beals Institute PC /ID# 163128	Lansing	Michigan
United States	Arthritis and Osteo Assoc /ID# 159994	Las Cruces	New Mexico
United States	Dartmouth-Hitchcock Medical Center /ID# 161235	Lebanon	New Hampshire
United States	Cape Fear Arthritis Care /ID# 161224	Leland	North Carolina
United States	Little Rock Diagnostics Clinic /ID# 165161	Little Rock	Arkansas
United States	University of California, Los Angeles /ID# 164542	Los Angeles	California
United States	West Texas Clinical Research /ID# 205722	Lubbock	Texas
United States	P&I Clinical Research /ID# 159826	Lufkin	Texas
United States	Mansfield Health Center /ID# 159805	Mansfield	Massachusetts
United States	VA Sacramento Medical Center /ID# 164196	Mather	California
United States	Dr. Ramesh Gupta /ID# 160061	Memphis	Tennessee
United States	Advanced Clinical Research /ID# 159894	Meridian	Idaho
United States	SW Rheumatology Res. LLC /ID# 159993	Mesquite	Texas
United States	LeJenue Research Associates /ID# 170965	Miami	Florida
United States	Precision Research Org, LLC /ID# 161287	Miami Lakes	Florida
United States	Trinity Health Med Arts Clinic /ID# 159800	Minot	North Dakota
United States	Medallion Clinical Research Institute, LLC /ID# 161228	Naples	Florida
United States	Ochsner Clinic Foundation-New Orleans /ID# 165672	New Orleans	Louisiana
United States	NYU Langone Medical Center /ID# 163230	New York	New York
United States	Health Research of Oklahoma /ID# 159880	Oklahoma City	Oklahoma
United States	Westroads Clinical Research /ID# 159979	Omaha	Nebraska
United States	Millennium Research /ID# 159822	Ormond Beach	Florida
United States	Four Rivers Clinical Research /ID# 159982	Paducah	Kentucky
United States	Arthritis Center, Inc. /ID# 163465	Palm Harbor	Florida
United States	Gulf Region Clinical Res Inst /ID# 159851	Pensacola	Florida
United States	SunValley Arthritis Center, Lt /ID# 161221	Peoria	Arizona
United States	Clinical Research Source, Inc. /ID# 164545	Perrysburg	Ohio
United States	AZ Arthritis & Rheuma Research /ID# 160037	Phoenix	Arizona
United States	AZ Arthritis and Rheumotology Research, PLLC /ID# 159981	Phoenix	Arizona
United States	AZ Arthritis and Rheumotology Research, PLLC /ID# 160033	Phoenix	Arizona
United States	AZ Arthritis and Rheumotology Research, PLLC /ID# 160036	Phoenix	Arizona
United States	Trinity Universal Research Association /ID# 205721	Plano	Texas
United States	St. Lawrence Health System /ID# 159848	Potsdam	New York
United States	Shanahan Rheuma & Immuno /ID# 159987	Raleigh	North Carolina
United States	OrthoIllinois /ID# 164546	Rockford	Illinois
United States	Shores Rheumatology, PC /ID# 159889	Saint Clair Shores	Michigan
United States	Clayton Medical Associates dba Saint Louis Rheumatology /ID# 159878	Saint Louis	Missouri
United States	BayCare Medical Group /ID# 159792	Saint Petersburg	Florida
United States	Arthritis & Osteo Ctr of S. TX /ID# 163784	San Antonio	Texas
United States	East Bay Rheumatology Medical /ID# 166382	San Leandro	California
United States	Arthritis Clinic of Central TX /ID# 164049	San Marcos	Texas
United States	Santa Fe Rheumatology /ID# 163783	Santa Fe	New Mexico
United States	Swedish Medical Center /ID# 159890	Seattle	Washington
United States	Clinical Investigation Specialists - Skokie /ID# 160062	Skokie	Illinois
United States	West Virginia Research Inst /ID# 159791	South Charleston	West Virginia
United States	Arthritis Northwest, PLLC /ID# 166380	Spokane	Washington
United States	Clinvest Research LLC /ID# 161227	Springfield	Missouri
United States	Stamford Therapeutics Consorti /ID# 165131	Stamford	Connecticut
United States	Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 163464	Summerville	South Carolina
United States	W. Broward Rheum Assoc Inc. /ID# 161388	Tamarac	Florida
United States	BayCare Medical Group, Inc. /ID# 159879	Tampa	Florida
United States	Clinical Research of West Florida, Inc /ID# 160063	Tampa	Florida
United States	University of South Florida /ID# 161286	Tampa	Florida
United States	DM Clinical Research /ID# 161735	Tomball	Texas
United States	Atlantic Coast Research /ID# 159799	Toms River	New Jersey
United States	Ocean Rheumatology, PA /ID# 163898	Toms River	New Jersey
United States	AZ Arth & Rheum Res /ID# 166381	Tucson	Arizona
United States	Inland Rheum Clin Trials Inc. /ID# 159828	Upland	California
United States	STAT Research, Inc. /ID# 161392	Vandalia	Ohio
United States	Deerbrook Medical Associates /ID# 159804	Vernon Hills	Illinois
United States	Arthritis & Osteoporosis Clinic /ID# 159786	Waco	Texas
United States	The Center for Rheumatology & Bone Research /ID# 159874	Wheaton	Maryland
United States	Medvin Clinical Research /ID# 160034	Whittier	California
United States	Clinical Pharmacology Study Gr /ID# 158700	Worcester	Massachusetts
United States	PA Regional Center /ID# 165670	Wyomissing	Pennsylvania
United States	Florida Medical Clinic /ID# 159992	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belarus,  Belgium,  Bosnia and Herzegovina,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Croatia,  Czechia,  Estonia,  Germany,  Greece,  Hong Kong,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Puerto Rico,  Russian Federation,  Serbia,  Singapore,  Slovakia,  Slovenia,  South Africa,  Spain,  Switzerland,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response 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
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	Percentage of Participants Achieving a Static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at Least a 2-point Improvement From Baseline (sIGA 0/1) at Week 16	The sIGA is a 5 point scale ranging from 0 to 4, based on the investigator's assessment of the average elevation, erythema, and scaling of all psoriatic lesions at the current visit. A lower score indicates less severe psoriasis (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe).	Baseline and Week 16
Secondary	Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at Week 16	PASI is a composite score based on the percentage of the body surface area (BSA) affected by psoriasis and the intensity of erythema (reddening), induration (thickening or hardening of the skin), and desquamation (peeling of the skin) of lesions assessed at 4 anatomic sites (head, upper extremities, trunk, and lower extremities). At each location, the percentage of BSA involvement is assigned a score from 0 (no involvement) to 6 (90% to 100% involvement), and erythema, induration, and desquamation are scored on a scale from 0 (no symptoms) to 4 (very marked).; The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from Baseline in PASI score, and was assessed in participants with Baseline psoriasis BSA involvement = 3%.	Baseline and Week 16
Secondary	Change From Baseline in Modified PsA Total Sharp/Van Der Heijde Score (mTSS) at Week 24	The Sharp-van der Heijde modified scoring method for PsA measures the level of joint damage from radiographs of the hands and feet, and was assessed by 2 independent, blinded readers.; Joint erosion severity was assessed in 20 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 320 (worst).; Joint space narrowing (JSN) was assessed in 20 joints of each hand and wrist, and 6 joints of each foot, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 208 (worst).; Joints with gross osteolysis or pencil in cup were assigned the maximum score for both erosions and JSN.; The total mTSS score is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 528 (worst). A negative change from Baseline indicates improvement in joint damage.	Baseline and Week 24
Secondary	Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24	A participant was classified as achieving MDA if 5 of the following 7 criteria were met: Tender joint count (out of 68 joints) = 1; Swollen joint count (out of 66 joints) = 1; PASI score = 1 (score ranges from 0 - 72) or percent BSA involved with psoriasis = 3%; Patient's assessment of pain = 1.5 (NRS from 0 to 10); Patient's Global Assessment of disease activity = 2 (NRS from 0 to 10); HAQ-DI score = 0.5 (index score ranges from 0 to 3); Leeds Enthesitis Index = 1 (assesses the presence or absence of enthesitis at 3 bilateral sites, with an overall score range from 0 to 6)	Week 24
Secondary	Percentage of Participants With Resolution of Enthesitis at Week 24	Resolution of enthesitis is defined as a Leeds Enthesitis Index (LEI) score = 0.; LEI is an enthesitis measure developed specifically for PsA and assesses the presence or absence of tenderness at the following 3 bilateral enthesial sites: medial femoral condyles, lateral epicondyles of the humerus, and Achilles tendon insertions. Tenderness on examination is recorded as either present (coded as 1), absent (coded as 0), or not assessed for each of the 6 sites. The LEI is calculated by taking the sum of the scores from the 6 sites. The LEI ranges from 0 to 6 (worst).	Week 24
Secondary	Percentage of Participants With an ACR20 Response at Week 12 - Non-inferiority Versus Adalimumab	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
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	Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12	The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue (e.g., I feel tired), functional fatigue (e.g., trouble finishing things), emotional fatigue (e.g., frustration), and social consequences of fatigue (e.g., limits social activity). Participants respond to the questions on a scale from 0 'not at all' to 4 'very much'. The FACIT Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement.	Baseline and Week 12
Secondary	Percentage of Participants With an ACR20 Response at Week 12 - Superiority Versus Adalimumab	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
Secondary	Percentage of Participants With Resolution of Dactylitis at Week 24	Resolution of dactylitis is defined as a Leeds Dactylitis Index (LDI) score = 0.; The Leeds Dactylitis Index (LDI) is a score based on finger circumference and tenderness, assessed and summed across all dactylitic digits (fingers and toes). The presence of a dactylitic digit is defined as at least one affected AND tender digit with circumference increase over reference digit = 10%. The reference digit circumference is either the contralateral digit (unaffected digit on opposite hand or foot) if available, or from a standard reference table if otherwise. Tenderness of affected digits is assessed on a scale from 0 [none] to 3 [worst].; The ratio of circumference between an affected digit and reference digit is multiplied by the tenderness score for each affected digit. The results from each involved digit are summed to provide the final LDI. A higher LDI indicates worse dactylitis.	Week 24
Secondary	Change From Baseline in Patient's Assessment of Pain - Superiority Versus Adalimumab	Participants were asked to indicate the severity of their arthritis pain within the previous week on a numerical rating scale (NRS) from 0 to 10. A score of 0 indicates "no pain" and a score of 10 indicates "worst possible pain." A negative change from Baseline indicates improvement.	Baseline and Week 12
Secondary	Change From Baseline in HAQ-DI - Superiority Versus Adalimumab	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 Self-Assessment of Psoriasis Symptoms (SAPS) Questionnaire at Week 16	The SAPS is an 11-item self-assessment of psoriasis symptoms that includes questions on: pain, itching, redness, scaling, flaking, bleeding, burning, stinging, tenderness, pain due to skin cracking, and joint pain. Each item is scored from 0 to 10, with 0 being least severe and 10 being most severe. The total score is generated by summing the 11 items and ranges from 0 to 110 (worst). A negative change from Baseline in the total score indicates improvement.	Baseline and Week 16
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 2	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 2

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•   This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.