Rhematoid Arthritis Clinical Trial
— ORAL STRATEGYOfficial title:
A Phase 3b/4 Randomized Double Blind Study Of 5 Mg Of Tofacitinib With And Without Methotrexate In Comparison To Adalimumab With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis
| Verified date | May 2018 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To assess the efficacy of tofacitinib monotherapy or tofacitinib with methotrexate as compared to adalimumab with methotrexate. To compare the efficacy of tofacitinib monotherapy compared to tofacitinib combined with methotrexate. To compare effects on all health outcomes measures in the study. To evaluate the safety and tolerability of tofacitinib and adalimumab. To evaluate the safety of the zoster vaccine given prior to the initiation of tofacitinb or adalimumab.
| Status | Completed |
| Enrollment | 1152 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Have moderate to severe rheumatoid arthritis - On methotrexate but inadequately controlled - Subjects must not have active tuberculosis or an inadequately treated tuberculosis infection - Subjects must use contraception Exclusion Criteria: - Subjects who have been previously treated with adalimumab or Tofacitinib - Subjects with any current malignancy or a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ. - Subjects with specific laboratory test abnormalities - Subjects with specific types of infections |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Organizacion Medica de Investigacion S.A - OMI | Buenos Aires | |
| Argentina | Atencion Integral en Reumatologia (AIR) | Caba | Buenos Aires |
| Argentina | CER San Juan, Centro Polivalente de Asistencia e Investigacion Clinica | San Juan | |
| Argentina | Centro Medico Privado de Reumatologia | San Miguel de Tucuman | Tucuman |
| Argentina | Centro Radiologico Luis Mendez Collado SRL | San Miguel de Tucuman | Tucuman |
| Australia | Royal Prince Alfred Hospital | Camperdown | New South Wales |
| Australia | Emeritus Research | Malvern East | Victoria |
| Australia | Pacific Private Clinic | Southport | Queensland |
| Australia | QML Pathology | Southport | Queensland |
| Australia | RK Will Pty Ltd | Victoria Park | Western Australia |
| Australia | The Queen Elizabeth Hospital | Woodville South | South Australia |
| Bosnia and Herzegovina | University Hospital Clinical Center Banja Luka | Banja Luka | Republika Srpska |
| Bosnia and Herzegovina | University Clinical Center Tuzla | Tuzla | |
| Bulgaria | UMHAT "Dr. Georgi Stranski" EAD | Pleven | |
| Bulgaria | MHAT "Kaspela" EOOD | Plovdiv | |
| Bulgaria | MHAT EUROHOSPITAL Plovdiv | Plovdiv | |
| Bulgaria | MHAT Akta Medika OOD | Ruse | |
| Bulgaria | MHAT Ruse AD | Ruse | |
| Bulgaria | MHAT Shumen AD | Shumen | |
| Bulgaria | MHAT Lyulin EAD | Sofia | |
| Bulgaria | NMTH Tsar Boris Clinic of Internal Diseases | Sofia | |
| Bulgaria | MHAT "Targovishte" AD | Targovisthe | |
| Canada | Kw Musculoskeletal Research Inc | Kitchener | Ontario |
| Canada | Centre de Recherche Musculo-Squelettique | Trois-Rivieres | Quebec |
| Chile | Quantum Research | Puerto Varas | X Region |
| Chile | Quantum Research Ltda | Puerto Varas | X Region |
| Chile | Prosalud | Santiago | Metropolitana |
| Chile | Estudios Clinicos Quinta Region Ltda. | Vina del Mar | Valparaiso |
| Czechia | Revmatologie s.r.o. | Brno | |
| Czechia | Revmacentrum MUDr. Mostera, s.r.o. | Brno - Zidenice | Czech Republic |
| Czechia | Revmatologicka ambulance | Ceska Lipa | |
| Czechia | Vesalion, s.r.o. | Ostrava- Moravska Ostrava | |
| Czechia | Revmatologie | Praha 4 | |
| Estonia | Foundation Parnu Hospital | Parnu | |
| Estonia | East-Tallinn Central Hospital Ltd | Tallinn | |
| Estonia | North Estonia Medical Centre Foundation | Tallinn | |
| Israel | Bnai Zion Medical Center | Haifa | |
| Israel | Rambam Health Care Campus | Haifa | |
| Israel | Hadassah Medical Center | Jerusalem | |
| Israel | The Chaim Sheba Medical Center | Tel-Hashomer | |
| Korea, Republic of | Daegu Catholic University Medical Center | Daegu | |
| Korea, Republic of | Kyungpook National University Hospital | Daegu | |
| Korea, Republic of | Chonnam National University Hospital | Gwangju | |
| Korea, Republic of | Inha University Hospital | Jung-Gu | Incheon |
| Korea, Republic of | Hanyang University Seoul Hospital | Seoul | |
| Korea, Republic of | Konkuk University Medical Center | Seoul | |
| Latvia | Health Center 4 | Riga | |
| Latvia | ORTO clinic Ltd | Riga | |
| Lithuania | Alytaus District S. Kudirkos Hospital | Alytus | |
| Lithuania | VAKK "Clinic of Dr. Kilda" | Kaunas | |
| Lithuania | PI Republican Siauliai Hospital | Siauliai | |
| Mexico | Investigacion y Biomedica de Chihuahua, SC | Chihuahua | |
| Mexico | Centro de Investigacion de Tratamientos Innovadores de Sinaloa S.C. | Culiacan | Sinaloa |
| Mexico | Centro de Investigacion en Tratamientos Innovadores de Sinaloa S.C. | Culiacan | Sinaloa |
| Mexico | Centro Integral en Reumatologia, SA de CV | Guadalajara | Jalisco |
| Mexico | Centro de Integral en Reumatologia SA de CV | Jalisco | |
| Mexico | Centro Multidisciplinario para el Desarrollo Especializado de la Invetigacion Clinica en Yucatan | Merida | Yucatan |
| Mexico | Departamento de Imagen de Hospital Star Medica Merida | Merida | Yucatan |
| Mexico | Laboratorio clínico del Hospital Star Medica Merida | Merida | Yucatan |
| Mexico | Storage for lab kits and study materials | Merida | Yucatan |
| Mexico | CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C. Consultorio Medico de Reumatologia | Mexico | Distrito Federal |
| Mexico | Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C. | San Luis Potosi | |
| Mexico | Unidad de Investigaciones Reumatologicas A.C. | San Luis Potosi | |
| Mexico | Unidad de Enfermedades Reumaticas y Cronico Degenerativas S. C. | Torreon | Coahuila |
| Peru | Unidad de Investigacion en Medicina Interna y Enfermedades criticas-Hogar Clinica San Juan de Dios | Arequipa | |
| Peru | ABK REUMAR S.R.L. de Medicentro Biociencias_ BIO CIENCIAS PERU S.R.L. | Lima | |
| Peru | Instituto Peruano del Hueso y la Articulacion | Lima | |
| Peru | Investigaciones Clinicas S.A.C. | Lima | |
| Philippines | Perpetual Succour Hospital | Cebu City | |
| Philippines | Brokenshire Integrated Health Ministries, Inc. | Davao | Davao DEL SUR |
| Philippines | Davao Doctors Hospital | Davao | |
| Philippines | Iloilo Doctors' Hospital, Inc | Iloilo City | Iloilo |
| Philippines | St. Paul's Hospital of Iloilo, Inc. | Iloilo City | |
| Philippines | Mary Mediatrix Medical Center | Lipa City | Batangas |
| Philippines | Jose R. Reyes Memorial Medical Center-Rayuma Klinik | Manila | Metro Manila |
| Philippines | University of the Philippines Manila-Philippine General Hospital | Manila | Metro Manila |
| Philippines | Far Eastern University - NRMF Medical Center | Quezon City | Metro Manila |
| Philippines | St. Luke's Medical Center | Quezon City | Metro Manila |
| Poland | Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy, | Bydgoszcz | |
| Poland | Centrum Medyczne SILESIANA Sp. z o.o. | Bytom | |
| Poland | Nzoz Bif-Med | Bytom | |
| Poland | Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka | Elblag | |
| Poland | Synexus Polska Sp. z o.o. Oddzial w Gdyni | Gdynia | |
| Poland | Synexus Polska Sp. z o.o. Oddzial w Katowicach | Katowice | |
| Poland | Medica Pro Familia Sp. z o.o. S.K.A. Oddzial Krakow | Krakow | Malopolska |
| Poland | Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna | Lodz | |
| Poland | Lecznica MAK-MED, NZOZ | Nadarzyn | |
| Poland | Prywatna Praktyka Lekarska | Poznan | |
| Poland | Centrum Medyczne Amed | Warszawa | WOJ Mazowieckie |
| 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 | |
| Romania | S.C. Clinica Somesan S.R.L. | Baia Mare | Maramures |
| Romania | Spitalul Judetean de Urgenta "Dr. Constantin Opris" | Baia Mare | Maramures |
| Romania | Centrul Clinic de Boli Reumatismale "Dr. Ion Stoia" | Bucuresti | |
| Romania | Ianuli Med Consult SRL, Reumatologie | Bucuresti | |
| Romania | Spitalul Clinic "Dr. I. Cantacuzino" | Bucuresti | |
| Romania | Spitalul Clinic Sf. Maria | Bucuresti | |
| Romania | Spitalul Clinic Sf. Maria, Medicina interna - Reumatologie | Bucuresti | |
| Romania | Spitalul Clinic Judetean de Urgenta Cluj Napoca Reumatologie | Cluj Napoca | Cluj |
| Romania | Spitalul Clinic Judetean de Urgenta - "Sf.Apostol Andrei" Galati | Galati | |
| Romania | Spitalul Clinic de Recuperare Iasi | Iasi | |
| Romania | Covamed Serv SRL | Sfantu Gheorghe | Covasna |
| Russian Federation | SAHI of KR "Kemerovo Regional Clinical Hospital" | Kemerovo | |
| Russian Federation | CJSC "European Medical Center" | Moscow | |
| Russian Federation | SBEI HPE First Moscow State Medical University n.a.I.M.Sechenov of MoH of RF based on UCH#1 | Moscow | |
| Russian Federation | SBEI HPE Novosibirsk State Medical University of MoH of RF | Novosibirsk | |
| Russian Federation | State Budgetary Healthcare Institution "Orenburg Regional Clinical Hospital" | Orenburg | |
| Russian Federation | Republic Hospital n.a. V.A. Baranov | Petrozawodsk | Karelia Republic |
| Russian Federation | State Budgetary Healthcare Institution of Karelia Republic "Republic Hospital n.a. V.A. Baranov" | Petrozawodsk | Karelia Republic |
| Russian Federation | State Budgetary Institution of Ryazan Region "Regional Clinical Cardiology Dispensary" | Ryazan | |
| Russian Federation | Limited Liability Company AVA-PETER | Saint Petersburg | |
| Russian Federation | State Budgetary Institution of Healthcare "Samara Regional Clinical Hospital n.a. V.D. Seredavin" | Samara | |
| Russian Federation | State Institution of Healthcare "Regional Clinical Hospital" | Saratov | |
| Russian Federation | Non-state Healthcare Institution "Regional Hospital at Smolensk Station of OJSC "Russian Railways" | Smolensk | |
| Russian Federation | State Autonomous Healthcare lnstitution of Yarostavl Region | Yaroslavl | |
| Russian Federation | State Budgetary Healthcare Institution of Yaroslavl Region "Clinical Hospital #3" | Yaroslavl | |
| South Africa | Iatros International | Bloemfontein | FREE State |
| South Africa | Arthritis Clinical Research Trials | Cape Town | Western CAPE |
| South Africa | Panorama Medical Centre | Cape Town | Western CAPE |
| South Africa | Netcare St Augustine's Hospital | Durban | Kwazulu-natal |
| South Africa | LCS Clinical Research Unit | Johannesburg | Gauteng |
| South Africa | WCR: Wits Clinical Research | Johannesburg | Gauteng |
| South Africa | WCR: Wits Clinical Research Charlotte Maxeke Johannesburg Academic Hospital | Johannesburg | Gauteng |
| South Africa | Charlotte Maxeke Johannesburg Academic Hospital | Parktown, Johannesburg | Gauteng |
| South Africa | Clinical Research Unit, University of Pretoria | Pretoria | Gauteng |
| South Africa | Netcare Jakaranda Hospital | Pretoria | Gauteng |
| South Africa | University of Pretoria | Pretoria | Gauteng |
| South Africa | Wineland Medical Research Centre | Stellenbosch | Western CAPE |
| Spain | Complexo Hospitalario Universitario A Coruna | A Coruna | |
| Spain | Hospital Clinic de Barcelona | Barcelona | |
| Spain | Hospital Universitario Fundacion Jimenez Diaz | Madrid | |
| Spain | Hospital Regional Universitario de Malaga | Malaga | |
| Spain | Complejo Hospitalario Universitario de Santiago de Compostela, Hospital Clinico Universitario | Santiago de Compostela | A Coruna |
| Spain | Hospital Infanta Luisa | Sevilla | |
| Taiwan | Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation | Hualien | |
| Taiwan | Kaohsiung Medical University Chung-Ho Memorial Hospital - New | Kaohsiung | |
| Taiwan | Kaohsiung Veterans General Hospital | Kaohsiung | |
| Taiwan | Chung Shan Medical University Hospital | Taichung | Taiwan ROC |
| Taiwan | Taipei Veterans General Hospital | Taipei | |
| Taiwan | Chang Gung Medical Foundation - Linkou Branch | Taoyuan County | |
| Thailand | Cardiology Unit,Department of Medicine, Faculty of Medicine, Ramathibodi Hospital,Mahidol University | Bangkok | |
| Thailand | Div. of Allergy Immunology and Rheumatology, Dept. of Medicine, | Bangkok | |
| Thailand | Phramongkutklao Hospital | Bangkok | Rajthevi |
| Thailand | Siriraj Hospital Mahidol University | Bangkok | |
| Thailand | Songklanagarind Hospital - Prince of Songkhla University | Songkhla | |
| Turkey | Ankara Universitesi Tip Fakultesi Ibn-i Sina Hastanesi | Ankara | |
| Turkey | Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uyg. ve Eg. | Samsun | |
| Turkey | Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uygulama ve Egitim Merkezi | Samsun | |
| Turkey | Cumhuriyet Universitesi Tip Fakultesi Hastanesi | Sivas | |
| United Kingdom | The Royal Wolverhamptons NHS Trust | Cannock | |
| United Kingdom | The Dudley Group NHS Foundation Trust | Dudley | WEST Midlands |
| United Kingdom | The Leeds Teaching Hospitals NHS Trust | Leeds | |
| United Kingdom | Aintree University Hospital NHS Foundation Trust | Liverpool | |
| United Kingdom | Royal Free London NHS Foundation Trust | London | |
| United States | AARDS Research, Inc. | Aventura | Florida |
| United States | Arthritis and Rheumatic Disease Specialties | Aventura | Florida |
| United States | Ochsner Clinic Baton Rouge | Baton Rouge | Louisiana |
| United States | Accurate Clinical Management, LLC | Baytown | Texas |
| United States | Joao M. A. Nascimento | Bridgeport | Connecticut |
| United States | Low Country Rheumatology, PA | Charleston | South Carolina |
| United States | Coeur D'Alene Arthritis Clinic | Coeur d'Alene | Idaho |
| United States | Medvin Clinical Research | Covina | California |
| United States | Arthritis Care And Diagnostic Center, P.A. | Dallas | Texas |
| United States | Metroplex Clinical Research Center | Dallas | Texas |
| United States | Altoona Center For Clinical Research | Duncansville | Pennsylvania |
| United States | Riverside Clinical Research | Edgewater | Florida |
| United States | Arthritis and Osteoporosis Treatment and Research Center | Flowood | Mississippi |
| United States | Centre for Rheumatology, Immunology and Arthritis | Fort Lauderdale | Florida |
| United States | Arthritis Treatment Center | Frederick | Maryland |
| United States | St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare | Fullerton | California |
| United States | Arthrocare, Arthritis Care & Research, PC | Gilbert | Arizona |
| United States | Accurate Clinical Management, LLC | Houston | Texas |
| United States | Houston Institute For Clinical Research | Houston | Texas |
| United States | Rheumatology Clinic of Houston, PA | Houston | Texas |
| United States | HealthCare Partners Medical Group | Huntington Beach | California |
| United States | Rheumatology Associates of North Alabama, PC | Huntsville | Alabama |
| United States | Institute of Arthritis Research | Idaho Falls | Idaho |
| United States | Diagnostic Rheumatology and Research PC | Indianapolis | Indiana |
| United States | West Tennessee Research Institute | Jackson | Tennessee |
| United States | Jacksonville Center for Clinical Research | Jacksonville | Florida |
| United States | Jasper Clinic | Kalamazoo | Michigan |
| United States | Keck Medicine of USC - Division of Rheumatology | Los Angeles | California |
| United States | Ronald Reagan UCLA Medical Center - Drug Information Center | Los Angeles | California |
| United States | UCLA David Geffen School of Medicine, Division of Rheumatology | Los Angeles | California |
| United States | University of Southern California (USC) Norris Comprehensive Cancer Center | Los Angeles | California |
| United States | Arthritis & Osteoporosis Associates, LLP | Lubbock | Texas |
| United States | Southwest Rheumatology Research, LLC. | Mesquite | Texas |
| United States | Trinity Health Center - Medical Arts | Minot | North Dakota |
| United States | Arthritis and Diabetes Clinic, Inc | Monroe | Louisiana |
| United States | Lynn Health Science Institute | Oklahoma City | Oklahoma |
| United States | Omega Research Consultants, LLC | Orlando | Florida |
| United States | Arthritis Center, Inc. | Palm Harbor | Florida |
| United States | Gulf Region Clinical Research Institute Llc | Pensacola | Florida |
| United States | Arthritis Group | Philadelphia | Pennsylvania |
| United States | Medvin Clinical Research | Placentia | California |
| United States | Dr. Prem C. Chatpar M.D.,LLC | Plainview | New York |
| United States | St. Louis Center For Clinical Research Barbara Caciolo, MD | Saint Louis | Missouri |
| United States | PMG Research of Salisbury, LLC | Salisbury | North Carolina |
| United States | Rowan Diagnostic Clinic | Salisbury | North Carolina |
| United States | Accurate Clinical Research, Inc. | San Antonio | Texas |
| United States | Arthritis & Osteoporosis Center of South Texas | San Antonio | Texas |
| United States | San Diego Arthritis Medical Clinic | San Diego | California |
| United States | Arthritis Northwest, PLLC | Spokane | Washington |
| United States | Clinvest/ A Division of Banyan Group, Inc. | Springfield | Missouri |
| United States | West Broward Rheumatology Associates, Inc. | Tamarac | Florida |
| United States | BayCare Medical Group Inc | Tampa | Florida |
| United States | Inland Rheumatology Clinical Trials, Inc. | Upland | California |
| United States | Medvin Clinical Research | Van Nuys | California |
| United States | Deerbrook Medical Associates | Vernon Hills | Illinois |
| United States | The Center for Arthritis and Rheumatism | Vero Beach | Florida |
| United States | The Office of Alastair C. Kennedy, MD | Vero Beach | Florida |
| United States | Medvin Clinical Research | Whittier | California |
| United States | PMG Research of Wilmington | Wilmington | North Carolina |
| United States | Advanced Clinical Research of Orlando, Inc. | Winter Garden | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Argentina, Australia, Bosnia and Herzegovina, Bulgaria, Canada, Chile, Czechia, Estonia, Israel, Korea, Republic of, Latvia, Lithuania, Mexico, Peru, Philippines, Poland, Romania, Russian Federation, South Africa, Spain, Taiwan, Thailand, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6 | ACR50 is a greater than or equal to (=) 50 percent (%) improvement in tender joint count (TJC) or swollen joint count (SJC) and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment (PGA) of disease activity, 2) participant's assessment (PtGA) of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein (CRP) at each visit. | Month 6 | |
| Secondary | Change From Baseline in Simplified Disease Activity Index (SDAI) Value at Month 6 | SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 centimeter (cm) visual analogue scale (VAS) (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI less than or equal to (=) 3.3 indicates disease remission, >3.4 to 11 indicates low disease activity, >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity. | Month 6 | |
| Secondary | Change From Baseline in Clinical Disease Activity Index (CDAI) Value at Month 6 | CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI =2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity. | Month 6 | |
| Secondary | Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including CRP at Month 6 | DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (millimeters [mm]) + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) =3.2 indicates low disease activity, >3.2 to 5.1 indicates moderate to high disease activity, and less than (<) 2.6 indicates remission. | Month 6 | |
| Secondary | Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including Erythrocyte Sedimentation Rate (ESR) at Month 6 | DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-3 (ESR) =3.2 indicates low disease activity, >3.2 to 5.1 indicates moderate to high disease activity, and <2.6 indicates remission. | Month 6 | |
| Secondary | Percentage of Participants Achieving Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria at Month 6 | To meet the ACR-EULAR Boolean remission criteria, a participant must satisfy all of the following: TJC =1 and SJC =1 (both based on a 28-joint assessment), CRP =1 mg/dL, and PtGA =1 on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). | Month 6 | |
| Secondary | Percentage of Participants Achieving SDAI =3.3 at Month 6 | SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI =3.3 indicates disease remission. | Month 6 | |
| Secondary | Percentage of Participants Achieving CDAI =2.8 at Month 6 | CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI =2.8 indicates disease remission. | Month 6 | |
| Secondary | Percentage of Participants Achieving DAS28-4 (ESR) <2.6 at Month 6 | DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) <2.6 indicates disease remission. | Month 6 | |
| Secondary | Percentage of Participants Achieving DAS28-4 (CRP) <2.6 at Month 6 | DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (mm) + 0.96. Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (CRP) <2.6 indicates remission. | Month 6 | |
| Secondary | Percentage of Participants Achieving SDAI =11 at Month 6 | SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI =3.3 indicates disease remission, >3.4 to 11 indicates low disease activity. | Month 6 | |
| Secondary | Percentage of Participants Achieving CDAI =10 at Month 6 | CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI =2.8 indicates disease remission, >2.8 to 10 indicates low disease activity. | Month 6 | |
| Secondary | Percentage of Participants Achieving DAS28-4 (ESR) =3.2 at Month 6 | DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) =3.2 indicates low disease activity. | Month 6 | |
| Secondary | Percentage of Participants Achieving DAS28-4 (CRP) =3.2 at Month 6 | DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) =3.2 indicates low disease activity. | Month 6 | |
| Secondary | Percentage of Participants Achieving American College of Rheumatology Criteria 20% Improvement (ACR20) Response at Month 6 | ACR20 response is a =20% improvement in TJC or SJC and 20% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. | Month 6 | |
| Secondary | Percentage of Participants Achieving American College of Rheumatology Criteria 70% Improvement (ACR70) Response at Month 6 | ACR70 response is a =70% improvement in TJC or SJC and 70% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. | Month 6 | |
| Secondary | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Month 6 | The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or 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 the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. | Month 6 | |
| Secondary | Percentage of Participants Achieving an HAQ-DI Decrease of at Least 0.22 at Month 6 | The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or 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 the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. A decrease of 0.22 or more is considered a positive response. | Month 6 | |
| Secondary | Change From Baseline in the Short-Form-36 (SF-36) Health Survey, Physical Component Score at Month 6 | The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based scores for both the SF-36 version 2 (v2) and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher PCS score represents better physical health status. | Month 6 | |
| Secondary | Change From Baseline in the SF-36 Health Survey, Mental Component Score at Month 6 | The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the PCS score and the MCS score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher MCS score represents better physical health status. | Month 6 | |
| Secondary | Change From Baseline in the SF-36 Health Survey, Physical Functioning Domain Score at Month 6 | SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 10 items of the physical functioning scale represent levels and kinds of limitations between extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence and extent of physical limitations using a 3-level response continuum. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher physical functioning domain score represents better physical functioning. | Month 6 | |
| Secondary | Change From Baseline in the SF-36 Health Survey, Role Physical Domain Score at Month 6 | SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item role physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; and d) accomplishing less. Items in the role physical scale are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role physical domain score represents better role physical functioning. | Month 6 | |
| Secondary | Change From Baseline in the SF-36 Health Survey, Bodily Pain Domain Score at Month 6 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher bodily pain domain score represents less bodily pain. | Month 6 | |
| Secondary | Change From Baseline in the SF-36 Health Survey, General Health Domain Score at Month 6 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The general health scale consists of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher general health domain score represents better general health perceptions. | Month 6 | |
| Secondary | Change From Baseline in the SF-36 Health Survey, Vitality Domain Score at Month 6 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher vitality domain score represents better vitality. | Month 6 | |
| Secondary | Change From Baseline in the SF-36 Health Survey, Social Functioning Domain Score at Month 6 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 2-item social functioning scale assesses health-related effects on quantity and quality of social activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher social functioning domain score represents better social functioning. | Month 6 | |
| Secondary | Change From Baseline in the SF-36 Health Survey, Role Emotional Domain Score at Month 6 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 3-item role emotional scale assesses mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. All 3 items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role emotional domain score represents better role emotional functioning. | Month 6 | |
| Secondary | Change From Baseline in the SF-36 Health Survey, Mental Health Domain Score at Month 6 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. All items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher mental health domain score represents better mental health functioning. | Month 6 | |
| Secondary | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | The WPAI: Rheumatoid Arthritis is a 6 item questionnaire that is specific for rheumatoid arthritis and yields four types of scores: absenteeism, presenteesism (impairment at work/reduced job effectiveness), work productivity loss and activity impairment. WPAI outcomes are expressed as impairment percentages ranging from 0 to 100, with higher numbers indicating greater impairment and less productivity. | Month 6 | |
| Secondary | Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | The EQ-5D is a 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"). This profile of scores across the 5-dimensions (e.g. 11231, 33212, etc.) is transformed into a single health utility score using a formula developed by the EuroQol Group that applies country specific preference weights. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rated the current health state on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicating a better health state. | Month 6 | |
| Secondary | Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Total Score at Month 6 | FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response (with the exception of 2 negatively stated), the greater the participant's 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). | Month 6 |