A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis

Spondyloarthritis Clinical Trial

— SELECT-AXIS 2  

Official title:

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects With Axial Spondyloarthritis Followed by a Remission-Withdrawal Period

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04169373
• Other study ID #: M19-944
• Secondary ID: 2022-501018-78-0
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 26, 2019
• Est. completion date: May 31, 2025

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This protocol includes 2 standalone studies with randomization, data collection, analysis and reporting conducted independently.

The main objectives of this protocol are:

• To evaluate the efficacy of upadacitinib compared with placebo on reduction of signs and symptoms in adults with active axial spondyloarthritis (axSpA) including biologic disease-modifying antirheumatic drug inadequate responders (bDMARD-IR) ankylosing spondylitis (AS) (Study 1) and non-radiographic axial spondyloarthritis (nr-axSpA) (Study 2).

• To assess the safety and tolerability of upadacitinib in adults with active axSpA including bDMARD-IR AS (Study 1) and nr-axSpA (Study 2).

• To evaluate the safety and tolerability of upadacitinib in extended treatment in adult participants with active axSpA including bDMARD-IR AS who have completed the Double-Blind Period (Study 1) and nr-axSpA who have completed the Double-Blind Period (Study 2).

• To evaluate the maintenance of disease control after withdrawal of upadacitinib.

Description:

Study 1 (bDMARD-IR AS) is comprised of a 14-week randomized, double-blind, parallel-group, placebo-controlled period (the Double-Blind Period); a 90-week open-label, long-term extension period (the Open-Label Extension Period); and a 30-day Follow-Up Visit (F/U Visit).

Study 2 (nr-axSpA) is comprised of a 52-week randomized, double-blind, parallel-group, placebo-controlled period (the Double-Blind Period); a 52-week open-label, long-term extension period (the Open-Label Extension Period); and a 30-day F/U Visit.

In the Double-Blind Period for both studies, participants are randomized in a 1:1 ratio to receive either upadacitinib or placebo once daily (QD).

Participants in the placebo group switch to upadacitinib 15 mg QD at Week 14 in the Open-Label Extension Period for Study 1 (bDMARD-IR AS) and Week 52 in the Open-Label Extension Period for Study 2 (nr-axSpA).

Participants in remission at Week 104 have the option to enroll in a remission-withdrawal period.

Study M19-944 protocol uses a common screening platform for determining eligibility into Study 1 and Study 2. Each study has its own objectives, hypothesis testing, randomization, data collection, and adequate power for primary and secondary endpoints. Analysis and reporting are conducted separately and independently for each study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 734
• Est. completion date: May 31, 2025
• Est. primary completion date: September 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Study 1:

• Must have a clinical diagnosis of ankylosing spondylitis (AS) and meet the modified New York Criteria for AS,

• Must not have total spinal ankylosis

• Must have been previously exposed to 1 or 2 bDMARDs (at least 1 tumor necrosis factor [TNF] inhibitor or 1 interleukin [IL]-17 inhibitor [IL-17i]), and must have discontinued the bDMARD therapy due to either lack of efficacy (after at least 12 weeks of treatment with a bDMARD at an adequate dose) or intolerance (irrespective of treatment duration). Prior exposure to two bDMARDs was allowed for no more than 30% of patients; among patients with prior exposure to two bDMARDs, a lack of efficacy to one bDMARD and intolerance to another was permitted, but a patient could not have a lack of efficacy to two bDMARDs

• Study 2:

• Must have a clinical diagnosis of nr-axSpA fulfilling the 2009 Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA but not meeting the radiologic criterion of the modified New York criteria for AS

• Must have objective signs of active inflammation consistent with axSpA on magnetic resonance imaging (MRI) of sacroiliac (SI) joints or based on high sensitivity C-reactive protein (hsCRP) > the upper limit of normal (ULN).

• Prior treatment with at most one bDMARD (either TNF inhibitor or IL-17i) is allowed for at least 20% but no more than 35% of enrolled patients who had to discontinue the prior bDMARD due to either lack of efficacy (after = 12 weeks at an adequate dose) or intolerance (regardless of treatment duration).

• Must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score = 4 at the Screening and Baseline Visits.

• Must have a Total Back Pain score = 4 based on a 0 - 10 numerical rating scale at the Screening and Baseline Visits.

• Has had an inadequate response to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or has an intolerance to or contraindication for NSAIDs as defined by the Investigator.

Exclusion Criteria:

• Must not have been exposed to any Janus kinase (JAK) inhibitor (including but not limited to upadacitinib [Rinvoq®], tofacitinib [Xeljanz®], baricitinib [Olumiant®], filgotinib, ruxolitinib [Jakafi®], abrocitinib [PF-04965842], and peficitinib [Smyraf®]).

• Prior bDMARD therapy must be washed out.

• Participant must not have a history of an allergic reaction or significant sensitivity to constituents of the study drug.

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis
• Spondylitis
• Spondyloarthritis

Intervention

Drug:
• Upadacitinib
Upadacitinib tablet administered orally
• Placebo
Placebo for upadacitinib tablet administered orally

Locations

Country	Name	City	State
Argentina	Organizacion Medica de Investigacion (OMI) /ID# 214557	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires
Argentina	Hospital Cordoba /ID# 215846	Cordoba
Argentina	Instituto Medico Strusberg /ID# 215239	Cordoba
Argentina	Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 214556	Rosario	Santa Fe
Argentina	Instituto CAICI /ID# 215242	Rosario	Santa Fe
Argentina	Centro de Investigaciones Medicas Tucuman /ID# 214559	San Miguel de Tucuman	Tucuman
Argentina	Cimer /Id# 215240	San Miguel de Tucuman
Australia	Emeritus Research Sydney /ID# 215507	Botany	New South Wales
Australia	Emeritus Research /ID# 215506	Camberwell	Victoria
Australia	Monash Medical Centre /ID# 215509	Clayton	Victoria
Australia	Barwon Rheumatology Services /ID# 215508	Geelong	Victoria
Australia	BJC Health /ID# 215510	Paramatta	New South Wales
Belgium	ReumaClinic /ID# 215005	Genk
Belgium	UZ Gent /ID# 215004	Gent	Oost-Vlaanderen
Belgium	Universitair Ziekenhuis Leuven /ID# 215006	Leuven	Vlaams-Brabant
Brazil	EDUMED Educacao em Saude S/S L /ID# 215111	Curitiba	Parana
Brazil	CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 215277	Juiz de Fora	Minas Gerais
Brazil	LMK Sevicos Medicos S/S /ID# 215112	Porto Alegre	Rio Grande Do Sul
Brazil	Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 215176	Sao Jose Do Rio Preto	Sao Paulo
Brazil	CPCLIN - Centro de Pesquisas Clínicas /ID# 215175	Sao Paulo
Bulgaria	Medical center Unimed /ID# 214816	Plovdiv
Bulgaria	MHAT Plovdiv /ID# 214815	Plovdiv
Bulgaria	UMHAT Kaspela EOOD /ID# 214803	Plovdiv
Bulgaria	Medical center Teodora /ID# 214813	Ruse
Bulgaria	Diagnostic consultative center 17 Sofia /ID# 214808	Sofia
Bulgaria	Medical center Excelsior /ID# 214805	Sofia
Bulgaria	UMHAT Sveti Ivan Rilski /ID# 214804	Sofia
Bulgaria	UMHAT Sveti Ivan Rilski /ID# 214806	Sofia
Canada	Applied Medical Informatics Research Inc. (AMIR) /ID# 215303	Montréal	Quebec
Canada	Centre de recherche du CHUQ /ID# 215038	Quebec
Canada	Toronto Western Hospital /ID# 215041	Toronto	Ontario
Canada	Centre de Recherche Musculo-Squelettique /ID# 215096	Trois-rivières	Quebec
Canada	Percuro Clinical Research, Ltd /ID# 215302	Victoria	British Columbia
China	The First Affiliated Hospital of BaoTou Medical College, Inner Mongolia Universi /ID# 216612	Baotou	Inner Mongolia
China	Peking Union Medical College Hospital /ID# 216545	Beijing	Beijing
China	The first affiliated hospital of bengbu medical college /ID# 216609	Bengbu	Anhui
China	Guangdong Provincial People's Hospital /ID# 216645	Guangzhou	Guangdong
China	Anhui Provincial Hospital /ID# 216631	Hefei	Anhui
China	First Affiliated Hospital of Kunming Medical University /ID# 217945	Kunming
China	Huashan Hospital, Fudan University /ID# 216646	Shanghai	Shanghai
China	The First Affiliated Hospital of Shantou University Medical College /ID# 217883	Shantou	Guangdong
China	Shenzhen People's Hospital /ID# 225438	Shenzhen	Guangdong
China	The First Affiliated Hospital of Soochow University /ID# 216607	Suzhou	Jiangsu
China	Zhuzhou Central Hospital /ID# 216644	Zhuzhou	Hunan
Czechia	Revmacentrum MUDr. Mostera, s.r.o. /ID# 215161	Brno
Czechia	REVMACLINIC s.r.o. /ID# 215153	Brno
Czechia	Revmatologie, s.r.o. /ID# 215309	Brno
Czechia	CCR Ostrava, s.r.o. /ID# 215226	Ostrava
Czechia	ARTHROHELP, s.r.o. /ID# 215224	Pardubice
Czechia	Fakultni Nemocnice v Motole /ID# 215160	Praha
Czechia	PV MEDICAL Services s.r.o. /ID# 215119	Praha
Czechia	Revmatologicka ambulance - MUDr. Zuzana Urbanova /ID# 215652	Praha
Czechia	Revmatologicky ustav v Praze /ID# 215154	Praha
Czechia	Thomayerova nemocnice /ID# 215118	Praha
Czechia	MEDICAL PLUS, s.r.o. /ID# 215324	Uherske Hradiste
France	CHU Bordeaux - Hopital Pellegrin /ID# 214784	Bordeaux
France	Hopital Ambroise Pare /ID# 214783	Boulogne Billancourt
France	AP-HP - Hopital Cochin /ID# 214782	Paris
France	CHU Toulouse /ID# 214780	Toulouse	Occitanie
Germany	Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 214211	Berlin
Germany	Rheumatologische Schwerpunktpraxis Brandt-Juergens /ID# 214282	Berlin
Germany	Rheuma Research Lausitz, Dr. Mario Sutowicz /ID# 214218	Cottbus
Germany	Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 214207	Dresden
Germany	Praxisgemeinschaft Rheumatologie Nephrologie Erlangen /ID# 214212	Erlangen
Germany	Universitaetsklinikum Erlangen /ID# 214281	Erlangen	Bayern
Germany	MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 214208	Hamburg
Germany	Medizinische Hochschule Hannover /ID# 214209	Hannover
Germany	MVZ für Rheumatologie Dr. M. Welcker GmbH /ID# 214261	Planegg
Hungary	Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 215183	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont /ID# 215187	Debrecen	Hajdu-Bihar
Hungary	Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 215186	Gyula
Hungary	Hevizgyogyfurdo es Szent Andras Reumakorhaz /ID# 215184	Heviz
Hungary	Pest Megyei Flor Ferenc Korhaz /ID# 214501	Kistarcsa
Hungary	Rehavita Kft HU /ID# 215188	Kormend	Zala
Hungary	CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 215181	Szekesfehervar
Hungary	Vital Medical Center Orvosi es Fogaszati Kozpont /ID# 215182	Veszprém	Veszprem
Israel	Bnai Zion Medical Center /ID# 215856	Haifa
Israel	Meir Medical Center /ID# 217255	Kfar Saba
Israel	The Chaim Sheba Medical Center /ID# 215854	Ramat Gan	Tel-Aviv
Israel	Tel Aviv Sourasky Medical Center /ID# 216956	Tel Aviv-Yafo	Tel-Aviv
Japan	National Hospital Organization Asahikawa Medical Center /ID# 214930	Asahikawa-shi	Hokkaido
Japan	Juntendo University Hospital /ID# 214929	Bunkyo-ku	Tokyo
Japan	St.Luke's International Hospital /ID# 215414	Chuo-ku	Tokyo
Japan	National Hospital Organization Osaka Minami Medical Center /ID# 214205	Kawachinagano Shi	Osaka
Japan	Kobe University Hospital /ID# 214598	Kobe-shi	Hyogo
Japan	Kuwana City Medical Center /ID# 215196	Kuwana-shi	Mie
Japan	Matsuyama Red Cross Hospital /ID# 216021	Matsuyama-shi	Ehime
Japan	Nagasaki University Hospital /ID# 215947	Nagasaki-shi	Nagasaki
Japan	Daido Clinic /ID# 214735	Nagoya-shi	Aichi
Japan	Hyogo College of Medicine College Hospital /Id# 215638	Nishinomiya-shi	Hyogo
Japan	Japanese Red Cross Okayama Hospital /ID# 214732	Okayama-shi	Okayama
Japan	Kita-harima Medical Center /ID# 216069	Ono-shi	Hyogo
Japan	Osaka City General Hospital /ID# 215640	Osaka-shi	Osaka
Japan	Hokkaido University Hospital /ID# 215221	Sapporo-shi	Hokkaido
Japan	Sasebo Chuo Hospital /ID# 214703	Sasebo-shi	Nagasaki
Japan	Okinawa Prefectural Chubu Hospital /ID# 215575	Uruma-shi	Okinawa
Korea, Republic of	Gachon University Gil Medical Center /ID# 214534	Incheon
Korea, Republic of	Asan Medical Center /ID# 214294	Seoul
Korea, Republic of	Hanyang University Seoul Hospital /ID# 214297	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Kyunghee University Hospital at Gangdong /ID# 214296	Seoul
Korea, Republic of	Seoul National University Hospital /ID# 214532	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 214295	Seoul
Korea, Republic of	Ajou University Hospital /ID# 214533	Suwon	Gyeonggido
Mexico	CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 215217	Mexico City	Ciudad De Mexico
New Zealand	Waikato Hospital /ID# 215503	Hamilton	Waikato
New Zealand	Middlemore Clinical Trials /ID# 215502	Papatoetoe	Auckland
Poland	Osteo-Medic S.C. /ID# 214351	Bialystok	Podlaskie
Poland	REUMED Sp.z o.o. Filia nr 1 /ID# 214353	Lublin	Lubelskie
Poland	ETYKA-Osrodek Badan Klinicznych /ID# 215572	Olsztyn	Warminsko-mazurskie
Poland	AI Centrum Medyczne Sp. z o.o. sp.k. /ID# 214354	Poznan	Wielkopolskie
Poland	Nasz Lekarz Przychodnie Medyczne /ID# 214352	Torun	Kujawsko-pomorskie
Poland	WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 215093	Wroclaw	Dolnoslaskie
Russian Federation	Chelyabinsk Regional Clinical Hospital /ID# 214463	Chelyabinsk	Chelyabinskaya Oblast
Russian Federation	Alliance Biomedical Ural Group /ID# 214457	Izhevsk	Udmurtskaya Respublika
Russian Federation	Immanuel Kant Baltic Federal University /ID# 218259	Kaliningrad	Kaliningradskaya Oblast
Russian Federation	Kazan State Medical University /ID# 214421	Kazan	Tatarstan, Respublika
Russian Federation	LLC Family Outpatient Clinic ? /ID# 214455	Korolev	Moskva
Russian Federation	City Clinical Hospital n.a. O.M. Filatov /ID# 214486	Moscow
Russian Federation	Olla-Med Clinic /ID# 214460	Moscow
Russian Federation	Research Institute of Rheumatology named after V.A. Nasonova /ID# 214459	Moscow	Moskva
Russian Federation	LLC Medical Center /ID# 214410	Novosibirsk	Novosibirskaya Oblast
Russian Federation	Omsk Regional Clinic Hospital /ID# 214464	Omsk
Russian Federation	Orenburg State Medical University /ID# 214408	Orenburg
Russian Federation	LLC Novaya Klinika /ID# 214420	Pyatigorsk	Stavropol Skiy Kray
Russian Federation	Ryazan State Medical University named after academician I.P. Pavlov /ID# 214418	Ryazan
Russian Federation	RZD-Medicine Saratov /ID# 214465	Saratov
Russian Federation	Clinical Rheumatologic Hospital No 25 /ID# 214488	St. Petersburg
Russian Federation	Nort-Western State Medical University n.a. Mechnikov /ID# 214454	St. Petersburg	Sankt-Peterburg
Russian Federation	Ulyanovsk Regional Clinical Hospital /ID# 214458	Ulyanovsk
Russian Federation	Central City Hospital #7 /ID# 214741	Yekaterinburg	Sverdlovskaya Oblast
Russian Federation	Family Clinic /ID# 214737	Yekaterinburg	Sverdlovskaya Oblast
Slovakia	Univerzitna nemocnica Bratislava Nemocnica Stare Mesto /ID# 214675	Bratislava
Slovakia	Reum.hapi s.r.o. /ID# 224268	Nove Mesto nad Vahom
Slovakia	Narodny ustav reumatickych chorob /ID# 214674	Piestany
Slovakia	MUDr. Zuzana Cizmarikova s.r.o. /ID# 215220	Poprad
Slovakia	ALBAMED s.r.o. /ID# 215248	Zvolen
Spain	Hospital Universitario Reina Sofia /ID# 214968	Cordoba
Spain	Hospital Universitario La Paz /ID# 216032	Madrid
Spain	Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 214967	Sabadell	Barcelona
Spain	Hospital Unversitario Marques de Valdecilla /ID# 214965	Santander	Cantabria
Spain	Hospital Universitario y Politecnico La Fe /ID# 214966	Valencia
Spain	Hospital Meixoeiro (CHUVI) /ID# 214969	Vigo	Pontevedra
Spain	Hospital Marina Baixa /ID# 215970	Villajoyosa	Alicante
Taiwan	Kaohsiung Veterans General Hos /ID# 214332	Kaohsiung	Taichung
Taiwan	Far Eastern Memorial Hospital /ID# 215384	New Taipei City
Taiwan	Chung Shan Medical University Hospital /ID# 214018	Taichung
Taiwan	China Medical University Hospital /ID# 214019	Taichung City
Taiwan	Cathay General Hospital /ID# 214183	Taipei
Turkey	Istanbul University Cerrahpasa Faculty of Medicine /ID# 214895	Cerrahpasa
Turkey	Mugla Sitki Kocman University Medical Faculty /ID# 215358	Mugla
Turkey	Hacettepe Universitesi Tip Fak /ID# 214898	Sihhiye	Ankara
Ukraine	MNPE Chernihiv Regional Hospital of the Chernihiv Region Council /ID# 214145	Chernihiv
Ukraine	CNCE of Kharkiv Regional Council Regional Clinical Hospital /ID# 214158	Kharkiv
Ukraine	MNI City Multidisciplinary Hospital #18 /ID# 214154	Kharkiv
Ukraine	State Institution L.T. Malaya Therapy National Institute of the NAMS of Ukraine /ID# 214155	Kharkiv
Ukraine	Khmelnytskyi Regional Hospital /ID# 214153	Khmelnytskyi
Ukraine	MI Kryvyi Rih City Clinical Hospital No.2 /ID# 214152	Kryvyi Rih
Ukraine	Kyiv Railway Clinical Hosp No.2 /ID# 214779	Kyiv
Ukraine	Medical Center CONSILIUM MEDICAL /ID# 216234	Kyiv
Ukraine	Medical Center LLC Institute of Rheumatology /ID# 214146	Kyiv
Ukraine	MNI KRC Kyiv Regional Clinical Hospital /ID# 214156	Kyiv
Ukraine	Multifield Medical Centre of ONMU /ID# 214149	Odesa
Ukraine	Municipal Non-Commercial Enterprise Odesa Regional Clinical Hospital of the Od /ID# 214159	Odesa
Ukraine	PI "Poltava Regional Clinical Hospital n.a. M.V.Sklifosovsky" /ID# 214151	Poltava
Ukraine	Ternopil University Hospital /ID# 214705	Ternopil
Ukraine	Clinic of Scientific Research Institute of Invalid Rehabilitation /ID# 214148	Vinnytsia
Ukraine	CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 214147	Vinnytsia
United Kingdom	Doncaster Royal Infirmary /ID# 214971	Armthorpe Road
United Kingdom	West Suffolk Hospital /ID# 215529	Bury St Edmunds	Suffolk
United Kingdom	Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 214865	Norwich	Norfolk
United Kingdom	Minerva Health Centre /ID# 216226	Preston	Lancashire
United States	Tekton Research, Inc. /ID# 214923	Austin	Texas
United States	Arthritis & Rheumatic Disease Specialties /ID# 215306	Aventura	Florida
United States	Rheumatology and Pulmonary Clinic /ID# 214946	Beckley	West Virginia
United States	Tufts Medical Center /ID# 215925	Boston	Massachusetts
United States	Trinity Universal Research Associates - Carrollton /ID# 214948	Carrollton	Texas
United States	Great Lakes Clinical Trials /ID# 215790	Chicago	Illinois
United States	Arthritis and Osteoporosis Clinic Of Brazos Valley /ID# 215805	College Station	Texas
United States	Denver Arthritis Clinic /ID# 215346	Denver	Colorado
United States	Wayne State University Health Center /ID# 215930	Detroit	Michigan
United States	Altoona Ctr Clinical Res /ID# 214770	Duncansville	Pennsylvania
United States	St. Paul Rheumatology /ID# 215537	Eagan	Minnesota
United States	Arizona Arthritis & Rheumatology Associates, P.C. /ID# 215282	Flagstaff	Arizona
United States	Tekton Research /ID# 215054	Fort Collins	Colorado
United States	JPS Rheumatology Clinic /ID# 215962	Fort Worth	Texas
United States	Klein and Associates MD /ID# 214767	Hagerstown	Maryland
United States	Sweet Hope Research Specialty Inc /ID# 215931	Hialeah	Florida
United States	Biopharma Informatic - Park Row /ID# 215907	Houston	Texas
United States	Biopharma Informatic, LLC /ID# 215885	Houston	Texas
United States	Memorial Rheumatology /ID# 216311	Houston	Texas
United States	Newport Huntington Medical Group /ID# 216281	Huntington Beach	California
United States	Advanced Rheumatology, PC /ID# 214973	Lansing	Michigan
United States	Cape Fear Arthritis Care /ID# 215927	Leland	North Carolina
United States	West Texas Clinical Research /ID# 215928	Lubbock	Texas
United States	Marietta Memorial Hospital /ID# 215929	Marietta	Ohio
United States	NYU Langone Orthopedic Center /ID# 215594	New York	New York
United States	Health Research of Oklahoma /ID# 215117	Oklahoma City	Oklahoma
United States	Innovation Medical Research Center /ID# 216068	Palmetto Bay	Florida
United States	AZ Arthritis and Rheumotology Research, PLLC /ID# 215113	Phoenix	Arizona
United States	Trinity Universal Research Associates, Inc /ID# 215189	Plano	Texas
United States	Oregon Health and Science University /ID# 216446	Portland	Oregon
United States	St. Lawrence Health System /ID# 215844	Potsdam	New York
United States	CenterPointe Institute of Research /ID# 215793	Saint Louis	Missouri
United States	Greater Chicago Specialty Physicians /ID# 216213	Schaumburg	Illinois
United States	Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 215055	Skokie	Illinois
United States	West Virginia Research Inst /ID# 214921	South Charleston	West Virginia
United States	STAT Research, Inc. /ID# 215264	Springboro	Ohio
United States	Clinvest Research LLC /ID# 215785	Springfield	Missouri
United States	Arizona Arthritis & Rheumatology Research, PLLC /ID# 214731	Tucson	Arizona
United States	Inland Rheum & Osteo Med Grp /ID# 215807	Upland	California
United States	Conquest Research /ID# 215804	Winter Park	Florida
United States	Clinical Pharmacology Study Group /ID# 215293	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Czechia,  France,  Germany,  Hungary,  Israel,  Japan,  Korea, Republic of,  Mexico,  New Zealand,  Poland,  Russian Federation,  Slovakia,  Spain,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study 1: Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 40 (ASAS40) Response at Week 14	ASAS40 response was defined as improvement of = 40% relative to Baseline and absolute improvement of = 2 units (on a scale from 0 to 10) in = 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units) in the potential remaining domain: Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity); Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).	Baseline and Week 14
Primary	Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 14	ASAS40 response was defined as improvement of = 40% relative to Baseline and absolute improvement of = 2 units (on a scale from 0 to 10) in = 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units) in the potential remaining domain: Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity); Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).	Baseline and Week 14
Secondary	Study 1: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 14	ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]); Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]); Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]); Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]); High-sensitivity C-reactive protein (hs-CRP) in mg/L.; The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS < 1.3) and very high disease (ASDAS > 3.5). A negative change from Baseline score indicates improvement in disease activity.	Baseline and Week 14
Secondary	Study 1: Change From Baseline in Magnetic Resonance Imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) Score for the Spine at Week 14	In the SPARCC MRI assessment of the spine, the entire spine was evaluated for active inflammation (bone marrow edema). Six discovertebral units (DVU) representing the 6 most abnormal DVUs were selected to calculate the MRI Spine SPARCC score. For each of the 6 DVUs, 3 consecutive sagittal slices were assessed in 4 quadrants to evaluate the extent of inflammation in all three dimensions.; Each quadrant was scored for the presence (1) or absence (0) of edema. If edema was present in at least one quadrant of a DVU slice, it was also scored for intensity and depth of the edema representing that slice: An additional score of 1 was assigned if an intense signal was seen in any quadrant on a DVU slice. Slices that included a lesion demonstrating continuous increased signal of depth = 1 cm extending from the endplate were scored as an additional 1 per slice.; The maximum (worst) overall score for all 6 DVUs is 108. A negative change from Baseline indicates improvement.	Baseline and Week 14
Secondary	Study 1: Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 14	The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For Questions 1 to 5 (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (= 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.; A BASDAI 50 response is defined as improvement of 50% or more from Baseline in BASDAI score.	Baseline and Week 14
Secondary	Study 1: Percentage of Participants With an ASAS20 Response at Week 14	ASAS20 response was defined as an improvement of = 20% and an absolute improvement of = 1 unit (on a scale of 0 to 10) from Baseline in at least 3 of the following 4 domains, with no deterioration (defined as a worsening of = 20% and a net worsening of = 1 units [on a scale of 0 to 10]) in the remaining domain: Patient's global assessment of disease activity, measured on a NRS from 0 (no activity) to 10 (severe activity); Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); Function, measured by the BASFI which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); Inflammation, measured by the mean of the 2 morning stiffness-related BASDAI NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).	Baseline and Week 14
Secondary	Study 1: Percentage of Participants With ASDAS Inactive Disease at Week 14	ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]); Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]); Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]); Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]); High-sensitivity C-reactive protein (hs-CRP) in mg/L.; The overall score ranges from 0 with no defined upper score. ASDAS Inactive Disease is defined as an ASDAS score < 1.3.	Week 14
Secondary	Study 1: Change From Baseline in Patient's Assessment of Total Back Pain at Week 14	Participants assessed their total back pain during the last week on a 0 to 10 numerical rating scale (NRS), where 0 represents no pain and 10 represents most severe pain.	Baseline and Week 14
Secondary	Study 1: Change From Baseline in Patient's Assessment of Nocturnal Back Pain at Week 14	Participants assessed the amount of back pain at night over the last week on a 0 to 10 NRS, where 0 represents no pain and 10 represents most severe pain.	Baseline and Week 14
Secondary	Study 1: Percentage of Participants With ASDAS Low Disease Activity at Week 14	ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]); Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]); Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]); Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]); High-sensitivity C-reactive protein (hs-CRP) in mg/L.; The overall score ranges from 0 with no defined upper score. ASDAS Low Disease Activity is defined as an ASDAS score < 2.1.	Week 14
Secondary	Study 1: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14	The Bath Ankylosing Spondylitis Functional Index is a validated index to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities such as putting on socks, bending, reaching, getting up from the floor or an armless chair, standing, climbing and other physical activities. Each item is scored on a NRS ranging from 0 (easy to perform an activity) to 10 (impossible to perform an activity). The overall score is the mean of the 10 items and ranges from 0 to 10 with higher scores indicating more functional limitations. A negative change from Baseline in BASFI indicates improvement.	Baseline and Week 14
Secondary	Study 1: Percentage of Participants With ASAS Partial Remission at Week 14	ASAS partial remission (PR) is defined as an absolute score of = 2 units on a 0 to 10 scale for each of the four following domains: Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity); Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).	Week 14
Secondary	Study 1: Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Week 14	The ASQoL consists of 18 items related to quality of life, including the impact of pain on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. Each item is answered as yes (scored as 1) or no (scored as 0).; Scores are summed to obtain the overall score which ranges from 0 to 18, where higher scores indicate a worse quality of life. A negative change from Baseline in ASQoL indicates improvement in quality of life.	Baseline and Week 14
Secondary	Study 1: Change From Baseline in ASAS Health Index at Week 14	The ASAS health index (HI) measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. Each of the 17 questions is answered by the participant as "I agree" (score = 1) or "I disagree" (score = 0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, where a higher score indicates a worse health status. A negative change from Baseline indicates improvement.	Baseline and Week 14
Secondary	Study 1: Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMI[Lin]) at Week 14	The BASMI is a composite score based on 5 direct measurements of spinal mobility: cervical rotation (measured in degrees),; tragus to wall distance (in centimeters [cm]); lumbar side flexion (in cm),; lumbar flexion (modified Schober's) (in cm) and; intermalleolar distance (in cm).; Each measurement is converted to a linear score between 0 and 10. The total BASMI(lin) score is the average of the 5 scores and ranges from 0 to 10; the higher the BASMI(lin) score the more severe the patient's limitation of movement due to their ankylosing spondylitis. A negative change from Baseline indicates improvement.	Baseline and Week 14
Secondary	Study 1: Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 14	The MASES evaluation was conducted to assess the presence or absence of enthesitis (inflammation of the entheses, or sites where tendons or ligaments insert into the bone) at 13 different sites (first costochondral joint left/right, seventh costochondral joint left/right, posterior superior iliac spine left/right, anterior superior iliac spine left/right, iliac crest left/right, fifth lumbar spinous process, and proximal insertion of Achilles tendon left/right. Each site was scored for presence (1) or absence (0) of enthesitis. The MASES is the sum of the 13 site scores, and ranges from 0 to 13, with higher scores indicating more inflammation of the entheses. A negative change from Baseline indicates improvement.	Baseline and Week 14
Secondary	Study 1: Change From Baseline in MRI SPARCC Score for Sacroiliac Joints at Week 14	In the SPARCC MRI assessment of the sacroiliac (SI) joints 6 consecutive sacroiliac joint image coronal slices representing the largest proportion of the synovial compartment of the SI joints were assessed for edema, intensity and depth of edema.; Each SI joint (left and right) was divided into quadrants for a total of 8 SI scoring locations. Each quadrant was scored for the presence (1) or absence (0) of edema, intensity of edema (a score of 1 was assigned for each SI joint (left and right) if an intense signal was seen in any quadrant of that joint for each slice), and a lesion was graded as deep (score of 1) if there was homogeneous and unequivocal increase in signal extending over a depth of at least 1 cm from the articular surface of the SI joint in any quadrant.; The total maximum (worst) score for all SI joints across 6 slices is 72. A negative change from Baseline indicates improvement.	Baseline and Week 14
Secondary	Study 2: Change From Baseline in ASDAS at Week 14	ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]); Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]); Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]); Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]); High-sensitivity C-reactive protein (hs-CRP) in mg/L.; The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS < 1.3) and very high disease (ASDAS > 3.5). A negative change from Baseline score indicates improvement in disease activity.	Baseline and Week 14
Secondary	Study 2: Change From Baseline in MRI SPARCC Score for SI Joints at Week 14	In the SPARCC MRI assessment of the sacroiliac (SI) joints 6 consecutive sacroiliac joint image coronal slices representing the largest proportion of the synovial compartment of the SI joints were assessed for edema, intensity and depth of edema.; Each SI joint (left and right) was divided into quadrants for a total of 8 SI scoring locations. Each quadrant was scored for the presence (1) or absence (0) of edema, intensity of edema (a score of 1 was assigned for each SI joint (left and right) if an intense signal was seen in any quadrant of that joint for each slice), and a lesion was graded as deep (score of 1) if there was homogeneous and unequivocal increase in signal extending over a depth of at least 1 cm from the articular surface of the SI joint in any quadrant.; The total maximum (worst) score for all SI joints across 6 slices is 72. A negative change from Baseline indicates improvement.	Baseline and Week 14
Secondary	Study 2: Percentage of Participants With BASDAI 50 Response at Week 14	The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For Questions 1 to 5 (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (= 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.; A BASDAI 50 response is defined as improvement of 50% or more from Baseline in BASDAI score.	Baseline and Week 14
Secondary	Study 2: Percentage of Participants With ASDAS Inactive Disease at Week 14	ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]); Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]); Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]); Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]); High-sensitivity C-reactive protein (hs-CRP) in mg/L.; The overall score ranges from 0 with no defined upper score. ASDAS Inactive Disease is defined as an ASDAS score < 1.3.	Week 14
Secondary	Study 2: Change From Baseline in Patient's Assessment of Total Back Pain at Week 14	Participants assessed their total back pain during the last week on a 0 to 10 numerical rating scale (NRS), where 0 represents no pain and 10 represents most severe pain.	Baseline and Week 14
Secondary	Study 2: Change From Baseline in Patient's Assessment of Nocturnal Back Pain at Week 14	Participants assessed the amount of back pain at night over the last week on a 0 to 10 NRS, where 0 represents no pain and 10 represents most severe pain.	Baseline and Week 14
Secondary	Study 2: Percentage of Participants With ASDAS Low Disease Activity at Week 14	ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]); Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]); Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]); Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]); High-sensitivity C-reactive protein (hs-CRP) in mg/L.; The overall score ranges from 0 with no defined upper score. ASDAS Low Disease Activity is defined as an ASDAS score < 2.1.	Week 14
Secondary	Study 2: Percentage of Participants With ASAS Partial Remission at Week 14	ASAS partial remission (PR) is defined as an absolute score of = 2 units on a 0 to 10 scale for each of the four following domains: Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity); Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).	Week 14
Secondary	Study 2: Change From Baseline in BASFI at Week 14	The Bath Ankylosing Spondylitis Functional Index is a validated index to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities such as putting on socks, bending, reaching, getting up from the floor or an armless chair, standing, climbing and other physical activities. Each item is scored on a NRS ranging from 0 (easy to perform an activity) to 10 (impossible to perform an activity). The overall score is the mean of the 10 items and ranges from 0 to 10 with higher scores indicating more functional limitations. A negative change from Baseline in BASFI indicates improvement.	Baseline and Week 14
Secondary	Study 2: Change From Baseline in ASQoL at Week 14	The ASQoL consists of 18 items related to quality of life, including the impact of pain on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. Each item is answered as yes (scored as 1) or no (scored as 0).; Scores are summed to obtain the overall score which ranges from 0 to 18, where higher scores indicate a worse quality of life. A negative change from Baseline in ASQoL indicates improvement in quality of life.	Baseline and Week 14
Secondary	Study 2: Change From Baseline in ASAS Health Index at Week 14	The ASAS HI measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. Each of the 17 questions is answered by the participant as "I agree" (score = 1) or "I disagree" (score = 0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, where a higher score indicates a worse health status. A negative change from Baseline indicates improvement.	Baseline and Week 14
Secondary	Study 2: Percentage of Participants Achieving an ASAS20 Response at Week 14	ASAS20 response was defined as an improvement of = 20% and an absolute improvement of = 1 unit (on a scale of 0 to 10) from Baseline in at least 3 of the following 4 domains, with no deterioration (defined as a worsening of = 20% and a net worsening of = 1 units [on a scale of 0 to 10]) in the remaining domain: Patient's global assessment of disease activity, measured on a NRS from 0 (no activity) to 10 (severe activity); Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); Function, measured by the BASFI which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); Inflammation, measured by the mean of the 2 morning stiffness-related BASDAI NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).	Baseline and Week 14
Secondary	Study 2: Change From Baseline in BASMI(Lin) at Week 14	The BASMI is a composite score based on 5 direct measurements of spinal mobility: cervical rotation (measured in degrees),; tragus to wall distance (in centimeters [cm]); lumbar side flexion (in cm),; lumbar flexion (modified Schober's) (in cm) and; intermalleolar distance (in cm).; Each measurement is converted to a linear score between 0 and 10. The total BASMI(lin) score is the average of the 5 scores and ranges from 0 to 10; the higher the BASMI(lin) score the more severe the patient's limitation of movement due to their ankylosing spondylitis. A negative change from Baseline indicates improvement.	Baseline and Week 14
Secondary	Study 2: Change From Baseline in MASES at Week 14	The MASES evaluation was conducted to assess the presence or absence of enthesitis (inflammation of the entheses, or sites where tendons or ligaments insert into the bone) at 13 different sites (first costochondral joint left/right, seventh costochondral joint left/right, posterior superior iliac spine left/right, anterior superior iliac spine left/right, iliac crest left/right, fifth lumbar spinous process, and proximal insertion of Achilles tendon left/right. Each site was scored for presence (1) or absence (0) of enthesitis. The MASES is the sum of the 13 site scores, and ranges from 0 to 13, with higher scores indicating more inflammation of the entheses. A negative change from Baseline indicates improvement.	Baseline and Week 14
Secondary	Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 52	ASAS40 response was defined as improvement of = 40% relative to Baseline and absolute improvement of = 2 units (on a scale from 0 to 10) in = 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units) in the potential remaining domain: Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity); Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).	Baseline and Week 52
Secondary	Study 2: Change From Baseline in MRI SPARCC Score for the Spine at Week 14	In the SPARCC MRI assessment of the spine, the entire spine is evaluated for active inflammation (bone marrow edema). Six discovertebral units (DVU) representing the 6 most abnormal DVUs were selected to calculate the MRI Spine SPARCC score. For each of the 6 DVUs, 3 consecutive sagittal slices were assessed in 4 quadrants to evaluate the extent of inflammation in all three dimensions.; Each quadrant was scored for the presence (1) or absence (0) of edema. If edema was present in at least one quadrant of a DVU slice, it was also scored for intensity and depth of the edema representing that slice: An additional score of 1 was assigned if an intense signal was seen in any quadrant on a DVU slice. Slices that included a lesion demonstrating continuous increased signal of depth = 1 cm extending from the endplate were scored as an additional 1 per slice.; The maximum (worst) overall score for all 6 DVUs is 108. A negative change from Baseline indicates improvement.	Baseline and Week 14
Secondary	Study 2: Percentage of Participants Who Initiated Rescue Treatment Between Week 24 and Week 52	Participants who did not achieve an ASAS20 response at any 2 consecutive scheduled visits from Week 24 through Week 52 were to be rescued with standard of care treatment as described in the protocol.	Week 24, Week 32, Week 40, and Week 52
Secondary	Study 2: Percentage of Participants With ASDAS Major Improvement at Week 52	ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]); Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]); Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]); Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]); High-sensitivity C-reactive protein (hs-CRP) in mg/L.; The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS < 1.3) and very high disease (ASDAS > 3.5). Major Improvement is defined as a change from Baseline of = -2.0.	Baseline and Week 52
Secondary	Study 2: Percentage of Participants With ASDAS Inactive Disease at Week 52	ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]); Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]); Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]); Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]); High-sensitivity C-reactive protein (hs-CRP) in mg/L.; The overall score ranges from 0 with no defined upper score. ASDAS Inactive Disease is defined as an ASDAS score < 1.3.	Week 52
Secondary	Study 2: Percentage of Participants With ASDAS Low Disease Activity at Week 52	ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]); Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]); Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]); Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]); High-sensitivity C-reactive protein (hs-CRP) in mg/L.; The overall score ranges from 0 with no defined upper score. ASDAS Low Disease Activity is defined as an ASDAS score < 2.1.	Week 52

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