Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX

Arthritis, Rheumatoid Clinical Trial

— ORAL1069  

Official title:

Phase 3 Randomized, Double-blind Study Of The Efficacy And Safety Of 2 Doses Of Cp-690,550 Compared To Methotrexate In Methotrexate Navie Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01039688
• Other study ID #: A3921069
• Secondary ID: 2009-016987-34
• Status: Completed
• Phase: Phase 3
• First received: December 23, 2009
• Last updated: March 8, 2018
• Start date: January 2010
• Est. completion date: March 2013

Study information

• Verified date: March 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This study will also compare the safety of CP-690,550 with methotrexate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 956
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated with methotrexate.

• Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.

• Active disease as defined by both >=6 tender or painful joints on motion and >= 6 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL

Exclusion Criteria:

• Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L

• History of any other rheumatic autoimmune disease other than Sjogren's syndrome

• No malignancy or history of malignancy

• History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug

• No chronic liver disease, recent or active hepatitis or other contraindication to methotrexate therapy

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• CP-690,550
Oral tablets administered at a dose of 5 mg BID for 24 months
• CP-690,550
Oral tablets administered at a dose of 10 mg BID for 24 months
• Disease-modifying antirheumatic drug
Oral capsules,administered as 10 mg per week for 4 weeks titrated to 15 mg per week for 4 weeks, then titrated to 20 mg week for 24 months

Locations

Country	Name	City	State
Argentina	Consultorios Reumatológicos Pampa	Buenos Aires
Argentina	OMI - Organización Médica de Investigación	Buenos Aires
Argentina	Saint Dennis Medical Group S.A.	Buenos Aires
Australia	Emeritus Research	Malvern East	Victoria
Australia	Rheumatology Research Unit Sunshine Coast	Maroochydore	Queensland
Australia	The Queen Elizabeth Hospital, Department of Rheumatology	Woodville	South Australia
Belgium	Universitair Ziekenhuis Gent - Reumatologie	Gent
Brazil	Centro de Estudos em Terapias Inovadoras	Curitiba	PR
Brazil	CIP - Centro Internacional de Pesquisas	Goiania	GO
Brazil	Clinica de Raios X Nabyh Salum S/S - Clinica Sao Matheus	Goiania	GO
Brazil	Hospital Sao Lucas da PUCRS	Porto Alegre	RS
Brazil	CCBR Brasil Centro de Pesquisas e Analises Clinicas Ltda	Rio de Janeiro
Brazil	CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda	Sao Paulo	SP
Bulgaria	Revmatologichno Otdelenie, MBAL - Plovdiv	Plovdiv
Bulgaria	MBAL-Ruse, AD, IV Terapevtichno i kardiologichno otdelenie	Ruse
Bulgaria	DKTs "Sveta Anna", Sofia; Konsultativen kabinet po Revmatologia	Sofia
Bulgaria	MBAL na Voennomeditsinska Akademia - Sofia, Klinika po Revmatologia i Kardiologia	Sofia
Bulgaria	MBAL Sveti Ivan Rilski Sofia; Klinika po Revmatologia	Sofia
Bulgaria	MOBAL "D-r Stefan Cherkezov" AD, Revmokardiologichno otdelenie s intenziven sektor	Veliko Tarnovo
Canada	Burlington Rheumatology and Osteoporosis Clinic	Burlington	Ontario
Canada	Rheumatology Research Associates Ltd.	Edmonton	Alberta
Canada	Dr. William G. Bensen Medicine Professional Corporation	Hamilton	Ontario
Canada	MAC Research Inc.	Hamilton	Ontario
Canada	Office of Dr. Fernando Bianchi	Hamilton	Ontario
Canada	KW Musculoskeletal Research Inc.	Kitchener	Ontario
Canada	Rheumatology Research Associates	Ottawa	Ontario
Canada	Niagara Peninsula Arthritis Centre	St. Catharines	Ontario
Canada	PerCuro Clinical Research Ltd.	Victoria	British Columbia
Canada	Clinical Research and Arthritis Centre	Windsor	Ontario
Canada	Windsor Radiological Associates	Windsor	Ontario
Canada	Manitoba Clinic	Winnipeg	Manitoba
Chile	Hospital Regional de Rancagua	Rancagua
Chile	Centro de Estudios Reumatologicos	Santiago	RM
Chile	Consulta Privada Dra. Marta Aliste	Santiago	RM
Chile	Consulta Privada Dra. Lucia Ponce	Temuco	IX Region
Chile	Estudios Clinicos V Region	Vina del Mar	V Region
Colombia	Centro de Reumatologia y Ortopedia	Barranquilla	Atlantico
Colombia	Centro Integral de Reumatologia e Inmunologia CIREI	Bogota	Cundinamarca
Colombia	Servimed E.U	Bucaramanga	Santander
Costa Rica	Centro de Reumatología y Osteoporosis, Cartago	Cartago
Costa Rica	Hospital Cima San Jose	San Jose
Czechia	Fakultni nemocnice Brno	Brno
Czechia	Revmacentrum MUDr. Mostera, s.r.o.	Brno - Zidenice
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czechia	Revmatologicka ambulance	Ostrava-Poruba
Czechia	Revmatologicky ustav	Praha 2
Czechia	Revmatologicka ambulance	Praha 4
Dominican Republic	Patricia Alvarez Site	Santo Domingo
Germany	Privat-Praxis, Rheumatologie (P515)	Aachen
Germany	Schlosspark-Klinik	Berlin
Germany	Studienambulanz, Medizinische Klinik 3 Universitaetsklinikum Erlangen	Erlangen
Germany	Schwerpunktpraxis Rheumatologie FAE Innere Medizin	Halle
Germany	Schoen Klinik Hamburg-Eilbek, Abt. Rheumatologie und Klin. Immunologie	Hamburg
Germany	Arztpraxis, Internist - Rheumatologie	Nuernberg
Germany	Rheumaforschung - Studienambulanz Dr. Wassenberg	Ratingen
Germany	Schwerpunktpraxis fuer Rheumatologie	Rheine
Hungary	Drug Research Center Kft. Reumatologiai Szakrendeles	Balatonfüred
Hungary	Revita Reumatologiai Rendelo	Budapest
Hungary	Synexus Magyarorszag Kft.	Budapest
Hungary	Mozgasszervi Rehabilitacios Kozpont, Reumatologiai szakrendeles	Mezokovesd
Hungary	MAV Korhaz es Rendelointezet	Szolnok
India	Rheumatic Disease Clinic	Ahmedabad	Gujarat
India	Shalby Hospital	Ahmedabad
India	Shirdi Sai Hospital	Bangalore	Karnataka
India	Mahavir Hospital & Research Center	Hyderabad	Andhra Pradesh
India	Arthritis Research and Care Foundation	Pune	Maharashtra
India	Jehangir Clinical Development Centre Pvt. Ltd.	Pune	Maharashtra
India	Department of Rheumatology	Secunderabad	Andhra Pradesh
Korea, Republic of	Asan Medical Center, Rheumatology, Internal Medicine	Seoul
Korea, Republic of	Seoul National University Hospital, Rheumatology, Internal Medicine	Seoul
Korea, Republic of	Yonsei University College of Medicine, Severance Hospital, Rheumatology, Internal Medicine	Seoul
Malaysia	Sarawak General Hospital	Kuching
Malaysia	Sunway Medical Centre	Petaling Jaya	Selangor Darul Ehsan
Malaysia	Hospital Tuanku Ja'afar	Seremban	Negeri Sembilan
Mexico	Instituto Jaliscience de Investigación Clínica SA de CV	Guadalajara	Jalisco
Mexico	Unidad de Investigacion en Enfermedades Cronico Degenerativas	Guadalajara	Jalisco
Mexico	Hospital Universitario Jose Eleuterio Gonzalez	Monterrey	Nuevo LEON
Mexico	Unidad de Enfermedades Reumaticas y Cronico Degenerativas SC	Torreon	Coahuila
New Zealand	The Canterbury Geriatric Medical Research Trust, c/- The Princess Margaret Hospital	Christchurch
New Zealand	Ryburns Building, Waikato Hospital	Hamilton
New Zealand	Centre for Clinical Research and Effective Practice (CCREP Middlemore Hospital	Otahuhu	Auckland
New Zealand	Timaru Hospital, Clinical Trials Unit	Timaru
Peru	Hospital Nacional IV Alberto Sabogal Sologuren	Callao
Peru	Centro Medico Corpac	Lima
Peru	Clinica Anglo Americana	Lima
Peru	Instituto Peruano del Hueso y la Articulacion SAC-Privado-Lima/Centro de Investigacion IPHAR	Lima
Philippines	Chong Hua Hospital	Cebu City
Philippines	Brokenshire Integrated Health Ministries, Inc. Brokenshire Memorial Hospital	Davao City
Philippines	Rayuma Klinik, OPD Department, Jose R. Reyes Memorial Medical Center	Manila
Poland	Centrum Leczenia Chorob Cywilizacyjnych Sp. z.o.o. SKA Oddzial Gdynia	Gdynia
Poland	Przychodnia Medyczna Lekarskiej Spoldzielni Pracy	Gdynia
Poland	Centrum Leczenia Chorob Cywilizacyjnych Sp. z o.o. SKA Oddzial Katowice	Katowice
Poland	Rheuma Medicus - Specjalistyczne Centrum Reumatologii i Osteoporozy	Warszawa
Poland	Synexus SCM Sp. z o.o. Oddzial Warszawa	Warszawa
Puerto Rico	Edificio Parra	Ponce
Puerto Rico	Ponce School of Medicine	Ponce
Russian Federation	State Healthcare Institution Regional Clinical Hospital	Barnaul
Russian Federation	Ltd. Medical Association "Novaya Bolnitsa" (X-Ray Only)	Ekaterinburg
Russian Federation	State Educational Institution of Higher Professional Education	Ekaterinburg
Russian Federation	State Healthcare Institution	Ekaterinburg
Russian Federation	State Healthcare Institution Regional Clinical Hospital for War Veterans	Kemerovo
Russian Federation	Federal State Institution named after Academician E.N. Meshalkin, Novosibirsk State Research	Novosibirsk
Russian Federation	Scientific Research Institute of Clinical and Experimental Lymphology of the Siberian Branch of RAMS	Novosibirsk
Russian Federation	Almazov Federal Heart, Blood and Endocrinology Centre	Saint Petersburg
Russian Federation	Smolensk State Medical Academy, Clinical Research Centre of Diagnostic Medicine and Drugs	Smolensk
Russian Federation	Clinical Hospital #122 named after L.G. Sokolov of the Federal Medical-Biological Agency	St. Petersburg
Russian Federation	St. Petersburg State Institution of Healthcare Consultative-diagnostic Center #85	St. Petersburg
Russian Federation	State Health Institution City Hospital # 25, City Rheumatology Center of St. Petersburg	St. Petersburg
Russian Federation	State Healthcare Institution City Hospital # 40 of Administrative Health Resort District	St. Petersburg
Russian Federation	Regional State Healthcare Institution of Tomsk Regional Clinical Hospital	Tomsk
Slovakia	Reumatolog s.r.o.	Bratislava
Slovakia	AAGS, s.r.o. , nestatne zdravotnicke zariadenie	Dunajska Streda
Slovakia	Reumatologicka ambulancia, Ecclesia, s.r.o.	Nove Zamky
Slovakia	Narodny ustav reumatickych chorob	Piestany
Slovakia	Nestatna reumatologicka ambulancia	Zilina
Spain	Hospital de Basurto	Bilbao	Vizcaya
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital Civil. Hospital Regional Universitario Carlos Haya	Malaga
Spain	Hospital Nuestra Señora de La Esperanza	Santiago de Compostela	A Coruña
Spain	Hospital Universitario Virgen Macarena	Sevilla
Sweden	Skanes Universitetssjukhus i Malmo	Malmo
Sweden	Sundsvalls sjukhus- Medicinkliniken	Sundsvall
Sweden	Akademiska sjukhuset, Reumatologmottagningen	Uppsala
Taiwan	Chung-Ho Memorial Hospital, Kaohsiung Medical University	Kaohsiung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Thailand	Rheumatology Unit, Department of Internal Medicine, Rajavithi Hospital	Bangkok
Thailand	Siriraj Hospital, Mahidol University	Bangkok
Thailand	Rheumatology Unit, Department of Internal Medicine, Phramongkutklao Hospital	Phayathai	Bangkok
Ukraine	State Institution "Republican Clinical Hospital of the Ministry of Health of Ukraine"	Kyiv
Ukraine	State Institution "Republican Clinical Hospital of the Ministry of Health of Ukraine"	Kyiv
Ukraine	Municipal City Clinical Hospital #4, Department of Rheumatology	Lviv
Ukraine	Municipal Establishment "City Clinical Hospital #9 n.a. O.I. Minakov", Department of Rheumatology	Odesa
Ukraine	CRI "Clinical Territorial Medical Association "University Clinic", Department of Rheumatology	Simferopol	Crimea
Ukraine	Vinnitsa Regional Clinical Hospital n.a. M.I. Pirogov	Vinnitsa
United States	The Center for Rheumatology	Albany	New York
United States	Austin Rheumatology Research	Austin	Texas
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Medical University of South Carolina - Rheumatology	Charleston	South Carolina
United States	Medical University of South Carolina Investigational Drug Services	Charleston	South Carolina
United States	Mountain State Clinical Research	Clarksburg	West Virginia
United States	United Hospital Center (Imaging Only)	Clarksburg	West Virginia
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	Medical Associates Clinic, PC	Dubuque	Iowa
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	University of North Texas Health Science Center at Fort Worth	Fort Worth	Texas
United States	Southeastern Arthritis Center	Gainesville	Florida
United States	Southeastern Imaging and Diagnostics	Gainesville	Florida
United States	Southeastern Integrated Medical, PL dba Florida Medical Research	Gainesville	Florida
United States	PMG Research of Hickory, LLC	Hickory	North Carolina
United States	PMG Research of Hickory, LLC	Hickory	North Carolina
United States	Diagnostic Rheumatology and Research, PC	Indianapolis	Indiana
United States	Arthritis Clinic	Jackson	Tennessee
United States	West Tennessee Research Institute	Jackson	Tennessee
United States	University of California San Diego Center for Innovative Therapy	La Jolla	California
United States	University of California San Diego Perlman Ambulatory Clinic	La Jolla	California
United States	Physician Research Collaboration, LLC	Lincoln	Nebraska
United States	Little Rock Diagnostic Clinic	Little Rock	Arkansas
United States	Keck Hospital of USC	Los Angeles	California
United States	Keck Hospital of USC, Lower Level Pharmacy	Los Angeles	California
United States	University of California Los Angeles (UCLA)	Los Angeles	California
United States	USC Keck School of Medicine	Los Angeles	California
United States	Center for Arthritis and Rheumatic Diseases	Miami	Florida
United States	Louisiana State University Health Sciences	New Orleans	Louisiana
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	AAIR Research Center	Rochester	New York
United States	Sarasota Arthritis Research Center	Sarasota	Florida
United States	Investigational Drug Service	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	West Broward Rheumatology Associates, Inc.	Tamarac	Florida
United States	Bernard F. Germain, MD	Tampa	Florida
United States	Burnette & Silverfield, MDS PLC	Tampa	Florida
United States	Catalina Pointe Clinical Research, Inc.	Tucson	Arizona
United States	The Center for Rheumatology and Bone Research	Wheaton	Maryland
United States	Clinical Pharmacology Study Group	Worcester	Massachusetts
United States	Clinical Research Center of Reading, LLP	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Colombia,  Costa Rica,  Czechia,  Dominican Republic,  Germany,  Hungary,  India,  Korea, Republic of,  Malaysia,  Mexico,  New Zealand,  Peru,  Philippines,  Poland,  Puerto Rico,  Russian Federation,  Slovakia,  Spain,  Sweden,  Taiwan,  Thailand,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Total Sharp Score (mTSS) at Month 6	mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).	Month 6
Primary	Change From Baseline at Month 6 in mTSS	mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.	Month 6
Primary	Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6	ACR70 response: greater than or equal to (=) 70 percent (%) improvement in tender joints count (TJC) or swollen joints count (SJC) and =70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of the Health Assessment Questionnaire [HAQ]), and 5) C-reactive protein (CRP).	Month 6
Primary	Absolute Blood Pressure (BP) Values (mmHg)	BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, and 24
Primary	Change From Baseline in BP Values (mmHg)	BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.	Months 1, 2, 3, 6, 9, 12, 15, 18, and 24
Secondary	mTSS Score at Baseline, Months 12 and 24	mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).	Baseline, Months 12 and 24
Secondary	Change From Baseline in mTSS Score at Months 12 and 24	mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.	Months 12 and 24
Secondary	Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24	mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). A increase of less than or equal to (=)0.5 in mTSS is considered to be no progression in the mTSS.	Months 6, 12, and 24
Secondary	Percentage of Participants With no Worsening in Erosion Score (Increase =0.5) at Months 6, 12, and 24	Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. An increase of =0.5 in Erosion Score is considered to be 'no worsening' in the Erosion Score.	Months 6, 12, and 24
Secondary	Erosion Scores	Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280.	Baseline, Months 6, 12, and 24
Secondary	JSN Scores	JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168.	Baseline, Months 6, 12, and 24
Secondary	Change From Baseline in Erosion Scores	Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. Change = score at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.	Months 6, 12, and 24
Secondary	Change From Baseline in JSN Scores	JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.	Months 6, 12, and 24
Secondary	Percentage of Participants Achieving an ACR70 Response	ACR70 response: =70% improvement in TJC or SJC and =70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.	Months 1, 2, 3, 9, 12, 15, 18, 21, and 24
Secondary	Percentage of Participants Achieving an ACR20 Response	ACR20 response: =20% improvement in TJC or SJC and =20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Percentage of Participants Achieving an ACR50 Response	ACR50 response: =50% improvement in TJC or SJC and =50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Tender Joints Count (TJC)	Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Change From Baseline in TJC	Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Swollen Joints Count (SJC)	Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Change From Baseline in SJC	Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Patient Assessment of Arthritis Pain	Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm=no pain and 100 mm=most severe pain.	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Change From Baseline in Patient Assessment of Arthritis Pain	Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm=no pain and 100 mm=most severe pain.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Physician Global Assessment of Arthritis	Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad.	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Change From Baseline in Physician Global Assessment of Arthritis	Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Patient Global Assessment of Arthritis	Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly.	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Change From Baseline in Patient Global Assessment of Arthritis	Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	C-Reactive Protein	CRP measured in milligrams per liter (mg/L)	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Change From Baseline in CRP	Change from Baseline in CRP measured in mg/L.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP	DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) less than or equal to (=)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) less than (<)2.6 = remission.	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])	DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter/hour [mm/hour]) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) =3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Change From Baseline in DAS28-3(CRP)	DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) =3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Change From Baseline in DAS28-4(ESR)	DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) =3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Percentage of Participants With DAS28-3(CRP) =3.2	DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) =3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Percentage of Participants With DAS28-4(ESR) =3.2	DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) =3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Percentage of Participants With DAS28-3(CRP) <2.6	DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) =3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Percentage of Participants With DAS28-4(ESR) <2.6	DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) =3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement)	DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement)	DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from BL), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Percentage of Participants With an ACR70 Response Sustained at Least 6 Months	ACR70 response: =70% improvement in TJC or SJC and =70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.	Months 6, 9, 12, 15, 18, 21, and 24
Secondary	Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits	ACR20 response: =20% improvement in TJC or SJC and =20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.	Months 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits	ACR50 response: =50% improvement in TJC or SJC and =50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.	Months 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits	ACR70 response: =70% improvement in TJC or SJC and =70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.	Months 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits	DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) =3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.	Months 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits	DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) =3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.	Months 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Health Assessment Questionnaire Disability Index (HAQ-DI)	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Change From Baseline in HAQ-DI Score	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Percentage of Participants With at Least 0.5 Improvement in HAQ-DI	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Short Form 36 (SF-36) Mental Component Score	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	SF-36 Physical Component Score	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Change From Baseline in SF-36 Mental Component Score	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Change From Baseline in SF-36 Physical Component Score	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	SF-36 Domain Scores	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Change From Baseline in SF-36 Domain Scores	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Work Limitation Questionnaire (WLQ) Score	WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Change From Baseline in WLQ Scores	WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	WLQ Work Loss Index Score	WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 [no loss] to 100 [complete loss of work]).	Baseline and Months 3, 6, and 12
Secondary	Change From Baseline in WLQ Work Loss Index Score	WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 [no loss] to 100 [complete loss of work]).	Months 3, 6, 12, 15, 18, 21, and 24
Secondary	European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.	Baseline and Months 3, 6, 12, 18, and 24
Secondary	Change From Baseline in EQ-5D Health State Profile Utility Score	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.	Months 3, 6, 12, 18, and 24
Secondary	Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6	Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.	Baseline and Months 3 and 6
Secondary	Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24	RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.	Months 12, 18, and 24
Secondary	Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.	Baseline and Months 3 and 6
Secondary	Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.	Months 12, 18, and 24
Secondary	Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.	Baseline and Months 3 and 6
Secondary	Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.	Months 12, 18, and 24
Secondary	Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6	RA-HCRU assessed healthcare (HC) usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.	Baseline and Months 3 and 6
Secondary	Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24	RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.	Months 12, 18, and 24
Secondary	Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU	Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.	Baseline, Months 3, 6, 12, 18, and 24
Secondary	Change From Baseline in Work Productivity and HCRU at Months 3 and 6	RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.	Months 3 and 6
Secondary	Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24	RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.	Months 12, 18, and 24
Secondary	Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.	Months 3 and 6
Secondary	Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24	RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.	Months 12, 18, and 24
Secondary	Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6	RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.	Months 3 and 6
Secondary	Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24	RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.	Months 12, 18, and 24
Secondary	Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6	RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.	Months 3 and 6
Secondary	Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24	RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.	Months 12, 18, and 24
Secondary	Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU	Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.	Months 3, 6, 12, 18, and 24
Secondary	Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3	Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.	Baseline and Months 1, 2, and 3
Secondary	Percentage of Participants With Optimal Sleep Assessed Using MOS-SS	MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported	Months 1, 2, 3, 6, 12, 18, and 24
Secondary	Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24	Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.	Months 6, 12, 18, and 24
Secondary	Change From Baseline in MOS-SS at Months 1, 2, and 3	Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.	Months 1, 2, and 3
Secondary	Change From Baseline in MOS-SS at Months 6, 12, 18, and 24	Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.	Months 6, 12, 18, and 24
Secondary	Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale	FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status	Baseline and Months 1, 2, 3, 6, 12, 18, and 24
Secondary	Change From Baseline in FACIT-Fatigue Scale	FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status	Months 1, 2, 3, 6, 12, 18, and 24
Secondary	Change From Baseline in Heart Rate		Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary	Change From Baseline in Temperature		Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

External Links

•   To obtain contact information for a study center near you, click here.