A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).

Rheumatoid Arthritis Clinical Trial

Official title:

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02480153
• Other study ID #: B5381002
• Secondary ID: B5381002, REFLEC
• Status: Completed
• Phase: Phase 3
• Start date: June 25, 2015
• Est. completion date: December 6, 2017

Study information

• Verified date: January 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will assess the efficacy, safety, and immunogenicity of PF-06410293 and adalimumab in combination with methotrexate in subjects with moderately to severly active rheumatoid arthritis who have had an inadequate response to methotrexate.

In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study treatment (PF-06410293) at home.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 597
• Est. completion date: December 6, 2017
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4 months.

• At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline.

• Hs-CRP equal or greater than 8 mg/L.

• Must have received methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose.

Exclusion Criteria:

• Evidence of untreated or inadequately treated latent or active TB.

• Evidence of uncontrolled, clinically significant diseases, including moderate or severe heart failure (NYHA Class III/IV) or malignancy in the previous 5 years.

• History of infection requiring hospitalization or parenteral antimicrobial therapy within 6 months prior to first dose of study drug.

• May have received no more than 2 doses of one biologic therapy (other than adalimumab or lymphocyte depleting therapy).

• Any second DMARD must be washed out prior to the first study dose.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• PF-06410293
PF-06410293 will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.
• Adalimumab
Adalimumab will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.

Locations

Country	Name	City	State
Australia	Paradise Arthritis & Rheumatology Pty Ltd	Southport	Queensland
Australia	RK Will Pty Ltd	Victoria Park	Western Australia
Australia	The Queen Elizabeth Hospital	Woodville South	South Australia
Brazil	EDUMED Educação em Saúde S/S Ltda	Curitiba	Paraná
Bulgaria	MHAT Plovdiv AD	Plovdiv
Bulgaria	University Multiprofile Hospital for Active Treatment (UMHAT) Kaspela EOOD	Plovdiv
Bulgaria	UMHAT "Sv. Ivan Rilski" EAD	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski" EAD	Sofia
Colombia	Fundacion Instituto de Reumatologia Fernando Chalem	Bogota
Czechia	Lekarna Na vrsku	Bruntal
Czechia	Revmatologie Bruntal, s.r.o.	Bruntal
Czechia	L.K.N. Arthrocentrum, s.r.o.	Hlucin
Czechia	Lekarna Vesalion	Ostrava
Czechia	Benu Lekarna	Pardubice
Czechia	CCBR-SYNARC, a.s.	Pardubice
Czechia	Revmatologicky ustav	Praha 2
Czechia	Lekarna Hradebni s.r.o.	Uherske Hradiste
Czechia	MEDICAL PLUS, s.r.o.	Uherske Hradiste
Estonia	East Tallinn Central Hospital	Tallinn
Estonia	Innomedica OÜ	Tallinn
Georgia	LTD "Unimed Adjara"	Batumi	Ajaria
Georgia	JSC Medical Corporation Evex	Tbilisi
Georgia	LTD Altravita	Tbilisi
Georgia	LTD Cardio-Reanimation Center	Tbilisi
Georgia	LTD Israeli-Georgian Medical Research Clinic Helsicore"	Tbilisi
Georgia	LTD.MediClubGeorgia	Tbilisi
Georgia	Tbilisi Heart and Vascular Clinic LTD	Tbilisi
Georgia	V.Tsitlanadze Scientifically-Practical Rheumatology Center	Tbilisi
Georgia	V.Tsitlanadze Scientifically-Practical Rheumatology Center LTD	Tbilisi
Georgia	Unimedi Kakheti Ltd, Telavi Referral Hospital	Telavi	Kakheti
Germany	Schlosspark-Klinik	Berlin
Germany	Gemeinschaftspraxis Dr. von Hinüber/Dr. Demary	Hildesheim
Germany	Klinikum der Universität München	München
Germany	Praxiszentrum St. Bonifatius	München
Germany	Rheumapraxis Dr. Martin Welcker und Kollegen	Planegg
Germany	Knappschaftsklinikum Saar GmbH	Püttlingen
Germany	Rheumazentrum Ratingen	Ratingen
Hungary	Qualiclinic Kft.	Budapest
Hungary	Debreceni Egyetem Klinikai Központ	Debrecen	Hajdú-bihar
Hungary	Vital Medical Center Orvosi es Fogorvosi Kozpont	Veszprem
Japan	Anjo Kosei Hospital	Anjo-shi	Aichi
Japan	Katayama Orthopaedic Rheumatology Clinic	Asahikawa	Hokkaido
Japan	National Hospital Organization Asahikawa Medical Center	Asahikawa	Hokkaido
Japan	Kondo clinic for rheumatism and orthopaedics	Fukuoka
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka
Japan	Matsubara Mayflower Hospital	Kato	Hyogo
Japan	Saitama Medical Center	Kawagoe	Saitama
Japan	National Hospital Organization Nagasaki Medical Center	Omura	Nagasaki
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Sapporo City General Hospital	Sapporo	Hokkaido
Japan	Inoue Hospital	Takasaki	Gunma
Japan	Hirose Clinic	Tokorozawa	Saitama
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Hanyang University Seoul Hospital	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Lithuania	LSMUL Kauno klinikos	Kaunas
Lithuania	Klaipedos universitetine ligonine	Klaipeda
Lithuania	Vilniaus universiteto ligonines Santariskiu klinikos	Vilnius
Mexico	Consultorio de Reumatologia	Ciudad de Mexico
Mexico	Consultorio Medico Privado de Reumatologia	Mexicali	BAJA California
New Zealand	Waikato Hospital	Hamilton
New Zealand	MedLab	Timaru	South Canterbury
New Zealand	Timaru Hospital	Timaru	South Canterbury
New Zealand	Timaru Rheumatology Studies	Timaru	South Canterbury
New Zealand	Wellington Hospital, Capital Coast District Health Board	Wellington
Peru	Unidad de Investigacion en Medicina Interna y Enfermedades Criticas	Arequipa
Peru	Oficina administrativa	Arequipa, Arequipa
Peru	ABK REUMA SRL-Medicentro Biociencias Peru SRL	Lima
Peru	Centro de Investigación para el Estudio de Enfermedades Reumáticas	Lima
Peru	Clinica Medica Cayetano Heredia	Lima
Peru	Instituto de Ginecología y Reproducción & Cirugía Mínimamente Invasiva	Lima
Peru	Oficina Administrativa	Lima, Lima
Poland	Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk	Bialystok
Poland	NZOZ Zdrowie Osteo-Medic s.c.	Bialystok
Poland	Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska	Elblag
Poland	NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. med. Barbara Bazela	Elblag
Poland	Synexus Polska Sp. z o.o. Oddzial w Gdyni	Gdynia
Poland	Centrum Medyczne Pratia Katowice	Katowice
Poland	Synexus Polska Sp. z o.o. Oddzial w Katowicach	Katowice
Poland	Zespol Poradni Specjalistycznych "REUMED" Filia nr 2	Lublin
Poland	NZOZ Lecznica MAK-MED. S.C.	Nadarzyn
Poland	Prywatna Praktyka Lekarska Prof. UM Dr Hab. Med. Pawel Hrycaj	Poznan
Poland	Niepubliczny Zaklad Opieki Zdrowotnej ''Nasz Lekarz''	Torun
Poland	''Rheuma Medicus'' Zaklad Opieki Zdrowotnej	Warszawa
Poland	Centrum Medyczne AMED	Warszawa
Poland	MTZ Clinical Research Sp. z o.o.	Warszawa
Poland	Synexus Polska Sp. z o.o. Oddzial w Warszawie	Warszawa
Poland	Synexus Polska Sp. z o.o. Oddzial we Wroclawiu	Wroclaw
Russian Federation	LLC Alliance Biomedical Ural group	Izhevsk
Russian Federation	GAUZ of Kemerovo Region "Regional clinical hospital for war veterans"	Kemerovo
Russian Federation	GMU Kursk Regional Clinical Hospital of the Healthcare Committee of the Kursk Region	Kursk
Russian Federation	GBUZ of city of Moscow City clinical hospital n.a. A.K.Eramishantsev of Ministry of Healthcare of	Moscow
Russian Federation	Municipal Clinical Hospital No. 1 Named after N.I. Pirogov	Moscow
Russian Federation	Orenburg State Medical Academy	Orenburg
Russian Federation	Regional Clinical Hospital	Orenburg
Russian Federation	GBUZ Republican hospital n.a. V.A. Baranov	Petrozavodsk	Republic OF Karelia
Russian Federation	GBOU VPO Ryazan State Medical University Named after Academician I.P. Pavlov	Ryazan
Russian Federation	GBU of Ryazan region Regional clinical cardiology dispanser	Ryazan
Russian Federation	Spb GBUZ "Clinical rheumatology hospital # 25" City CDC prevention of osteoporosis	Saint-Petersburg
Russian Federation	GUZ " Regional clinical hospital"	Saratov
Russian Federation	GBUZ VO Regional clinical hospital	Vladimir
Russian Federation	GBKUZ of Yaroslavl region "City hospital n. a. N.A. Semashko"	Yaroslavl
Serbia	Institute of Rheumatology	Belgrade
Serbia	Military Medical Academy,	Belgrade
Serbia	Institute for Treatment and Rehabilitation Niska Banja	Niska Banja
Serbia	Special Hospital for Rheumatic Diseases Novi Sad	Novi Sad
South Africa	Arthritis Clinical Research Trials, Dr. C.E Spargo and Dr. R.B Bhorat Practice	Cape Town	Western CAPE
South Africa	Panorama Medical Centre	Cape Town	Western CAPE
South Africa	St. Augustine's Hospital	Durban	Kwa-zulu Natal
South Africa	Charlotte Maxeke Johannesburg Academic Hospital	Johannesburg	Gauteng
South Africa	Clinresco Centres (Pty) Ltd	Kempton Park	Gauteng
Spain	Hospital Universitario A Coruña	A Coruña
Spain	Hospital Universitario Cruces	Barakaldo	Vizcaya
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Infanta Luisa	Sevilla
Taiwan	China Medical University Hospital	Taichung
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	Taipei Medical University Hospital	Taipei
Ukraine	Kyivska miska klinichna likarnia #6	Kyiv
Ukraine	Komunalna 4-a miska klinichna likarnia m. Lvova,	Lviv
Ukraine	Lvivskyi oblasnyi klinichnyi diahnostychnyi tsentr,	Lviv
Ukraine	Komunalnyi zaklad okhorony zdorovia "Kharkivska miska klinichna likarnia #8"	M. Kharkiv
Ukraine	Komunalnyi zaklad Kyivskoi oblasnoi rady "Kyivska oblasna klinichna likarnia",	M. Kyiv,
Ukraine	Bahatoprofilnyi medychnyi tsentr (Universytetska klinika #1)	Odesa
Ukraine	Komunalnyi zaklad Sumskoi oblasnoi rady "Sumska oblasna klinichna	Sumy
Ukraine	Vinnytska oblasna klinichna likarnia im. M.I.Pyrohova revmatolohichne viddilennia	Vinnytsia
Ukraine	Komunalna ustanova "Zaporizka oblasna klinichna likarnia" Zaporizkoi oblasnoi rady	Zaporizhzhia
United Kingdom	Basingstoke and North Hampshire Hospital, Hampshire Hospitals NHS Foundation Trust	Basingstoke	Hampshire
United Kingdom	Royal United Hospital Bath NHS Foundation Trust ,Royal National Hospital for Rheumatic Diseases	Bath	Somerset
United Kingdom	The Leeds Institute of Rheumatic and Musculoskeletal Medicine	Leeds	WEST Yorkshire
United Kingdom	Arrowe Park Hospital, Wirral University Teaching Hospitals NHS Foundation Trust	Wirral	Merseyside
United States	Amarillo Center for Clinical Research, Ltd.	Amarillo	Texas
United States	Austin Regional Clinic	Austin	Texas
United States	Arthritis and Rheumatic Disease Specialties	Aventura	Florida
United States	Bronson Internal Medicine and Rheumatology	Battle Creek	Michigan
United States	Rheumatology and Pulmonary Clinic	Beckley	West Virginia
United States	St Luke's Intermountain Research Center	Boise	Idaho
United States	Graves-Gilbert Clinic Bowling Green	Bowling Green	Kentucky
United States	Physician's Clinic of Iowa, P.C.	Cedar Rapids	Iowa
United States	Low Country Rheumatology, PA	Charleston	South Carolina
United States	Center for Arthritis and Rheumatic Diseases, P.C.	Chesapeake	Virginia
United States	Cincinnati Rheumatic Disease Study Group, Inc.	Cincinnati	Ohio
United States	Robert W. Levin, MD, PA	Clearwater	Florida
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	International Medical Research	Daytona Beach	Florida
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare	Fullerton	California
United States	SIMED Arthritis Center	Gainesville	Florida
United States	Southeastern Integrated Medical, PL, d/b/a Florida Medical Research	Gainesville	Florida
United States	ArthroCare, Arthritis Care & Research P.C.	Gilbert	Arizona
United States	Arizona Arthritis & Rheumatology Associates, PC	Glendale	Arizona
United States	Physicians East PA	Greenville	North Carolina
United States	The Clinical Research Institute of Houston, LLC	Houston	Texas
United States	West Tennessee Research Institute	Jackson	Tennessee
United States	Accurate Clinical Research	League City	Texas
United States	Physician Research Collaboration, LLC	Lincoln	Nebraska
United States	Ramesh C Gupta, M.D.	Memphis	Tennessee
United States	St Luke' s Clinic	Meridian	Idaho
United States	Southwest Rheumatology Research, LLC	Mesquite	Texas
United States	Manhattan Medical Research	New York	New York
United States	Javed Rheumatology Associates, Inc	Newark	Delaware
United States	Westroads Clinical Research, Inc.	Omaha	Nebraska
United States	Buffalo Rheumatology and Medicine PLLC	Orchard Park	New York
United States	Rheumatology Associates of Central Florida, P.A.	Orlando	Florida
United States	Arizona Arthritis & Rheumatology Associates, PC	Phoenix	Arizona
United States	Regional Health Clinical Research	Rapid City	South Dakota
United States	Regional Medical Clinic - Rheumatology	Rapid City	South Dakota
United States	East Bay Rheumatology Medical Group, Inc.	San Leandro	California
United States	Sarasota Arthritis Research Center	Sarasota	Florida
United States	Northwest Diagnostic Clinic, PA	Shenandoah	Texas
United States	Westlake Medical Research	Thousand Oaks	California
United States	North Mississippi Medical Clinics, Inc. - Clinical Research	Tupelo	Mississippi
United States	Inland Rheumatology Clinical Trials, Inc.	Upland	California
United States	Alastair C. Kennedy, MD	Vero Beach	Florida
United States	Indian River Primary Care	Vero Beach	Florida
United States	Desert Valley Medical Group	Victorville	California
United States	Arthritis, Rheumatic & Back Disease Associates, P.A.	Voorhees	New Jersey
United States	Wenatchee Valley Hospitals & Clinics	Wenatchee	Washington
United States	The Center for Rheumatology and Bone Research	Wheaton	Maryland
United States	Clinical Research of Reading, LLC	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Bulgaria,  Colombia,  Czechia,  Estonia,  Georgia,  Germany,  Hungary,  Japan,  Korea, Republic of,  Lithuania,  Mexico,  New Zealand,  Peru,  Poland,  Russian Federation,  Serbia,  South Africa,  Spain,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants Who Achieved Delivery Success in Sub-study	A sub-study was conducted to determine whether participants or their non-healthcare professional caregivers could safely and effectively administer PF-06410293 with the sponsor's prefilled pen (PFP) device.	Weeks 56, 58, 60, 62, 64, 66
Primary	Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12: Period 1	ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).	Week 12
Secondary	Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Other Time Points Other Than Week 12: Period 1	ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).	Weeks 2, 4, 6, 8, 18 and 26 (pre-dose)
Secondary	Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 2	ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).	Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary	Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 3	ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).	Weeks 52, 56, 66, 76 and 78
Secondary	Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 1	ACR50 is a categorical variable indicating a 50% or greater improvement in tender and swollen joint counts and 50% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).	Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary	Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 2	ACR50 is a categorical variable indicating a 50% or greater improvement in tender and swollen joint counts and 50% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).	Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary	Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 3	ACR50 is a categorical variable indicating a 50% or greater improvement in tender and swollen joint counts and 50% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).	Weeks 52, 56, 66, 76 and 78
Secondary	Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 1	ACR70 is a categorical variable indicating a 70% or greater improvement in tender and swollen joint counts and 70% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).	Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary	Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 2	ACR70 is a categorical variable indicating a 70% or greater improvement in tender and swollen joint counts and 70% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).	Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary	Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 3	ACR70 is a categorical variable indicating a 70% or greater improvement in tender and swollen joint counts and 70% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).	Weeks 52, 56, 66, 76 and 78
Secondary	Change From Baseline in Tender Joint Count: Period 1	Sixty-eight (68) joints were assessed by an independent blinded joint assessor to determine the number of joints that were considered tender. The 68 joints assessed were: upper body including temporomandibular, sternoclavicular, acromioclavicular; upper extremity including shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as 1 unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (PIP II, III, IV, V), and distal interphalangeals (DIP II, III, IV, V); lower extremity including hip, knee, ankle, tarsus (subtalar, transverse tarsal and tarsometatarsal considered as 1 unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe interphalangeal, proximal and distal interphalangeals combined (PIP and DIP II, III, IV, V).	Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary	Change From Baseline in Tender Joint Count: Period 2	Sixty-eight (68) joints were assessed by an independent blinded joint assessor to determine the number of joints that were considered tender. The 68 joints assessed were: upper body including temporomandibular, sternoclavicular, acromioclavicular; upper extremity including shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as 1 unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (PIP II, III, IV, V), and distal interphalangeals (DIP II, III, IV, V); lower extremity including hip, knee, ankle, tarsus (subtalar, transverse tarsal and tarsometatarsal considered as 1 unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe interphalangeal, proximal and distal interphalangeals combined (PIP and DIP II, III, IV, V).	Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary	Change From Baseline in Tender Joint Count: Period 3	Sixty-eight (68) joints were assessed by an independent blinded joint assessor to determine the number of joints that were considered tender. The 68 joints assessed were: upper body including temporomandibular, sternoclavicular, acromioclavicular; upper extremity including shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as 1 unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (PIP II, III, IV, V), and distal interphalangeals (DIP II, III, IV, V); lower extremity including hip, knee, ankle, tarsus (subtalar, transverse tarsal and tarsometatarsal considered as 1 unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe interphalangeal, proximal and distal interphalangeals combined (PIP and DIP II, III, IV, V).	Baseline, Weeks 52, 56, 66, 76 and 78
Secondary	Change From Baseline in Swollen Joint Count: Period 1	Sixty-six (66) joints were assessed for swelling, the same as those listed for tender joint count, excluding the right and left hip joints.	Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary	Change From Baseline in Swollen Joint Count: Period 2	Sixty-six (66) joints were assessed for swelling, the same as those listed for tender joint count, excluding the right and left hip joints.	Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary	Change From Baseline in Swollen Joint Count: Period 3	Sixty-six (66) joints were assessed for swelling, the same as those listed for tender joint count, excluding the right and left hip joints.	Baseline, Weeks 52, 56, 66, 76 and 78
Secondary	Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 1	The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease symptoms, functional capacity and physical examination, and independent of the participant's reported assessments of PGA (patient's global assessment of arthritis) and PAAP (patient's assessment of arthritis pain). The investigator's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled "None" and the 100 mm end labeled "Extreme".	Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary	Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 2	The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease symptoms, functional capacity and physical examination, and independent of the participant's reported assessments of PGA (patient's global assessment of arthritis) and PAAP (patient's assessment of arthritis pain). The investigator's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled "None" and the 100 mm end labeled "Extreme".	Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary	Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 3	The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease symptoms, functional capacity and physical examination, and independent of the participant's reported assessments of PGA (patient's global assessment of arthritis) and PAAP (patient's assessment of arthritis pain). The investigator's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled "None" and the 100 mm end labeled "Extreme".	Baseline, Weeks 52, 56, 66, 76 and 78
Secondary	Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 1	Participants assessed the severity of their arthritis pain using a 100 mm Visual Analog Scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.	Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary	Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 2	Participants assessed the severity of their arthritis pain using a 100 mm Visual Analog Scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.	Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary	Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 3	Participants assessed the severity of their arthritis pain using a 100 mm Visual Analog Scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.	Baseline, Weeks 52, 56, 66, 76 and 78
Secondary	Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 1	Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participant's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled "Very Well" and the 100 mm end labeled "Very Poorly".	Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary	Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 2	Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participant's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled "Very Well" and the 100 mm end labeled "Very Poorly".	Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary	Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 3	Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participant's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled "Very Well" and the 100 mm end labeled "Very Poorly".	Baseline, Weeks 52, 56, 66, 76 and 78
Secondary	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 1	HAQ-DI assesses the degree of difficulty a participant had experienced during the past week in 8 domains of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing "no difficulty", 1 as "some difficulty", 2 as "much difficulty", and 3 as "unable to do". Any activity that required assistance from another individual or required the use of an assistive device would adjust to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of scores divided by the number of domains answered. Total possible score range was 0-3 with 0 representing "no difficulty", 1 as "some difficulty", 2 as "much difficulty", and 3 as "unable to do". Higher score indicate more difficulty in performing daily living activities.	Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 2	HAQ-DI assesses the degree of difficulty a participant had experienced during the past week in 8 domains of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing "no difficulty", 1 as "some difficulty", 2 as "much difficulty", and 3 as "unable to do". Any activity that required assistance from another individual or required the use of an assistive device would adjust to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of scores divided by the number of domains answered. Total possible score range was 0-3 with 0 representing "no difficulty", 1 as "some difficulty", 2 as "much difficulty", and 3 as "unable to do". Higher score indicate more difficulty in performing daily living activities.	Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 3	HAQ-DI assesses the degree of difficulty a participant had experienced during the past week in 8 domains of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing "no difficulty", 1 as "some difficulty", 2 as "much difficulty", and 3 as "unable to do". Any activity that required assistance from another individual or required the use of an assistive device would adjust to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of scores divided by the number of domains answered. Total possible score range was 0-3 with 0 representing "no difficulty", 1 as "some difficulty", 2 as "much difficulty", and 3 as "unable to do". Higher score indicate more difficulty in performing daily living activities.	Baseline, Weeks 52, 56, 66, 76 and 78
Secondary	Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 1	Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.	Baseline, Weeks1, 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary	Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 2	Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.	Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary	Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 3	Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.	Baseline, Weeks 52, 56, 66, 76 and 78
Secondary	Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 1	The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. Higher score indicate more disease activity. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L).	Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary	Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 2	The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. Higher score indicate more disease activity. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L).	Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary	Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 3	The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. Higher score indicate more disease activity. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L).	Baseline, Weeks 52, 56, 66, 76 and 78
Secondary	Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1	EULAR response was based on DAS28 EULAR response criteria. Good response was achieved if DAS28 improvement from baseline >1.2 and DAS28 =<3.2. Moderate response was achieved if DAS28 improvement from baseline >0.6 to =<1.2 and DAS28 =<5.1; or DAS improvement from baseline >1.2 and DAS28 >3.2. No response was achieved if DAS improvement from baseline =<0.6 (no matter present DAS28 score); or DAS improvement from baseline >0.6 to =<1.2 and DAS28 >5.1.	Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary	Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2	EULAR response was based on DAS28 EULAR response criteria. Good response was achieved if DAS28 improvement from baseline >1.2 and DAS28 =<3.2. Moderate response was achieved if DAS28 improvement from baseline >0.6 to =<1.2 and DAS28 =<5.1; or DAS improvement from baseline >1.2 and DAS28 >3.2. No response was achieved if DAS improvement from baseline =<0.6 (no matter present DAS28 score); or DAS improvement from baseline >0.6 to =<1.2 and DAS28 >5.1.	Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary	Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3	EULAR response was based on DAS28 EULAR response criteria. Good response was achieved if DAS28 improvement from baseline >1.2 and DAS28 =<3.2. Moderate response was achieved if DAS28 improvement from baseline >0.6 to =<1.2 and DAS28 =<5.1; or DAS improvement from baseline >1.2 and DAS28 >3.2. No response was achieved if DAS improvement from baseline =<0.6 (no matter present DAS28 score); or DAS improvement from baseline >0.6 to =<1.2 and DAS28 >5.1.	Weeks 52, 56, 66, 76 and 78
Secondary	Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 1	The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L). Higher score indicate more disease activity; DAS28-4 (CRP) <2.6 indicates remission.	Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary	Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 2	The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L). Higher score indicate more disease activity; DAS28-4 (CRP) <2.6 indicates remission.	Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary	Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 3	The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L). Higher score indicate more disease activity; DAS28-4 (CRP) <2.6 indicates remission.	Weeks 52, 56, 66, 76 and 78
Secondary	Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response:Period 1	Participants were considered to be in ACR/EULAR remission when either of the following criteria was met: scores on the tender joint count, swollen joint count, hs-CRP (mg/dL) and PGA (0-10 cm scale) were all =<1; or the score on the simplified disease activity index (SDAI) was =<3.3. SDAI score was the sum of tender joint count (28), swollen joint count (28), PGA (0-10 cm scale), physician's global assessment of arthritis (PGAA, 0-10 cm scale) and hs-CRP (mg/dL).	Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary	Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 2	Participants were considered to be in ACR/EULAR remission when either of the following criteria was met: scores on the tender joint count, swollen joint count, hs-CRP (mg/dL) and PGA (0-10 cm scale) were all =<1; or the score on the simplified disease activity index (SDAI) was =<3.3. SDAI score was the sum of tender joint count (28), swollen joint count (28), PGA (0-10 cm scale), physician's global assessment of arthritis (PGAA, 0-10 cm scale) and hs-CRP (mg/dL).	Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary	Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 3	Participants were considered to be in ACR/EULAR remission when either of the following criteria was met: scores on the tender joint count, swollen joint count, hs-CRP (mg/dL) and PGA (0-10 cm scale) were all =<1; or the score on the simplified disease activity index (SDAI) was =<3.3. SDAI score was the sum of tender joint count (28), swollen joint count (28), PGA (0-10 cm scale), physician's global assessment of arthritis (PGAA, 0-10 cm scale) and hs-CRP (mg/dL).	Weeks 52, 56, 66, 76 and 78
Secondary	Serum Concentration Versus Time Summary: Period 1		Pre-dose on Days 1, 15, 43, 85 and 183, and at any time during Day 8 visit
Secondary	Serum Concentration Versus Time Summary: Period 2		Pre-dose on Days 183, 211, 253 and 365
Secondary	Serum Concentration Versus Time Summary: Period 3		Pre-dose on Days 365, 393, 463, 547 and 575
Secondary	Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 1	Serum samples were analyzed for the presence or absence of ADA using a semi-quantitative electrochemiluminescent (ECL) assay, and ADA positive was defined as ADA titer >=1.88. Serum samples tested positive for ADA were further analyzed for the presence or absence of NAb using a semi-quantitative cell-based assay, and NAb positive was defined as NAb titer >=0.70.	Baseline up to Week 26 (pre-dose)
Secondary	Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 2	Serum samples were analyzed for the presence or absence of ADA using a semi-quantitative electrochemiluminescent (ECL) assay, and ADA positive was defined as ADA titer >=1.88. Serum samples tested positive for ADA were further analyzed for the presence or absence of NAb using a semi-quantitative cell-based assay, and NAb positive was defined as NAb titer >=0.70.	Week 26 dosing up to Week 52 (pre-dose)
Secondary	Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 3	Serum samples were analyzed for the presence or absence of ADA using a semi-quantitative electrochemiluminescent (ECL) assay, and ADA positive was defined as ADA titer >=1.88. Serum samples tested positive for ADA were further analyzed for the presence or absence of NAb using a semi-quantitative cell-based assay, and NAb positive was defined as NAb titer >=0.70.	Week 52 dosing up to follow-up visit (Week 92)
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs for Period 1 were events between first dose of study drug in Period 1 and up to Week 26 pre-dose assessments that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug. AEs included both serious and non-serious AEs.	Baseline (Day 1) up to Week 26 (pre-dose)
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs for Period 2 were events between first dose of study drug in Period 2 and up to Week 52 pre-dose assessments that were absent before treatment or that worsened relative to prior state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug. AEs included both serious and non-serious AEs.	Week 26 dosing up to Week 52 (pre-dose)
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs for Period 3 were events between first dose of study drug in Period 3 and up to Week 92 visit that were absent before treatment or that worsened relative to prior state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug. AEs included both serious and non-serious AEs.	Week 52 dosing up to follow-up visit (Week 92)
Secondary	Number of Participants With Laboratory Abnormalities: Period 1	Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Each parameter was evaluated against commonly used and widely accepted criteria. Number of participants with any laboratory abnormality during Period 1 (without regard to baseline abnormality) is presented.	Baseline (Day 1) up to Week 26 (pre-dose)
Secondary	Number of Participants With Laboratory Abnormalities: Period 2	Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Each parameter was evaluated against commonly used and widely accepted criteria. Number of participants with any laboratory abnormality during Period 2 (without regard to baseline abnormality) is presented.	Week 26 dosing up to Week 52 (pre-dose)
Secondary	Number of Participants With Laboratory Abnormalities: Period 3	Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Each parameter was evaluated against commonly used and widely accepted criteria. Number of participants with any laboratory abnormality during Period 3 (without regard to baseline abnormality) is presented.	Week 52 dosing up to follow-up visit (Week 92)

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