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Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)

2019年1月8日 更新者：Pfizer

EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS

This extension study will evaluate the safety (including immunogenicity) of treatment with rituximab-Pfizer, as well as the safety and immunogenicity after transitioning from rituximab-US or rituximab-EU to rituximab-Pfizer. This study will provide continued treatment access to subjects with active rheumatoid arthritis who have participated for at least 16 weeks in other studies in the rituximab Pfizer program.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

185

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 以色列
      • Tel Hashomer、以色列、5262000
        • The Chaim Sheba Medical Center
  • 俄罗斯联邦
      • Kemerovo、俄罗斯联邦、650000
        • State Institution of Healthcare "Regional Clinical Hospital for Wars' Veterans"
      • Novosibirsk、俄罗斯联邦、630099
        • LLC Consulting and Diagnostic Rheumatological Center "Healthy Joints"
      • Samara、俄罗斯联邦、443095
        • State Budget Institution of Healthcare "Samara Regional Clinical Hospital named after V.D. Seredavin
      • Samara、俄罗斯联邦、443095
        • State Institution of Healthcare "Samara Regional Clinical Hospital named after V.D. Seredavin"
      • St Petersburg、俄罗斯联邦、191014
        • AVA-PETER Ltd.
      • St Petersburg、俄罗斯联邦、191025
        • Local Ethics Committee of LLC AVA-PETER
      • St. Petersburg、俄罗斯联邦、190068
        • St. Petersburg State Healthcare Institution "Clinical Rheumatology Hospital 25"
      • St. Petersburg、俄罗斯联邦、191014
        • "AVA-PETER" Ltd - Affiliate Address
      • St. Petersburg、俄罗斯联邦
        • Laboratory of LLC AVA-PETER
    • Republic OF Tatarstan
      • Kazan、Republic OF Tatarstan、俄罗斯联邦、420103
        • LLC Scientific and Research Medical Complex "Your Health"
  • 加拿大
      • Quebec、加拿大、G1W 4R4
        • Centre de Recherche Saint-Louis
      • Quebec、加拿大、G1V 3M7
        • Pharmacie Matte et Petit
    • Quebec
      • Rimouski、Quebec、加拿大、G5L 8W1
        • Centre de Rhumatologie de l'Est du Quebec
      • Rimouski、Quebec、加拿大、G5L 1J5
        • Clinique Medicale du Phare (ECG Only)
  • 南非
      • Cape Town、南非、7500
        • Panorama Medical Centre - Room 136
      • KwaZulu Natal、南非、3000
        • Dr. Jan Fourie Medical Centre
  • 哥伦比亚
    • Antioquia
      • Medellin、Antioquia、哥伦比亚
        • Rodrigo Botero S.A.S.
      • Medellin、Antioquia、哥伦比亚
        • IPS Rodrigo Botero S.A.S.
      • Medellín、Antioquia、哥伦比亚
        • Clínica Medellín S.A. Sede Centro
      • Medellín、Antioquia、哥伦比亚
        • Mix Supplier S.A.
    • Atlantico
      • Barranquilla、Atlantico、哥伦比亚
        • Centro de Reumatologia y Ortopedia
      • Barranquilla、Atlantico、哥伦比亚
        • Clinica de la Costa Ltda.
      • Barranquilla、Atlantico、哥伦比亚
        • Congregación de las Hermanas Franciscanas Misioneras de María Auxiliadora-Clinica La Asuncion
      • Barranquilla、Atlantico、哥伦比亚
        • IPS Centro Integral de Reumatologia del Caribe, CIRCARIBE S.A.S.
      • Barranquilla、Atlantico、哥伦比亚
        • IPS Centro Integral De Reumatologia del Caribe, CIRCARIBE S.A.S
      • Barranquilla、Atlantico、哥伦比亚
        • Organizacion Clinica General del Norte S.A.
  • 墨西哥
      • San Luis Potosi、墨西哥、78213
        • Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
      • San Luis Potosi、墨西哥、78200
        • Hospital Angeles, Centro Medico del Potosi
    • Distrito Federal
      • Mexico City、Distrito Federal、墨西哥、06700
        • C.T. Scanner de Mexico, S.A. de C.V. (CT ONLY)
      • Mexico City、Distrito Federal、墨西哥、06700
        • CLIDITER, S.A de C.V.
      • Mexico City、Distrito Federal、墨西哥、06700
        • Hospital Angeles Clinica Londres
    • Jalisco
      • Guadalajara、Jalisco、墨西哥、44650
        • Private Office
      • Guadalajara、Jalisco、墨西哥、44200
        • Hospital Bernardette (Emergencies)
  • 德国
      • Berlin、德国、14059
        • Schlosspark-Klinik GmbH, Internal Medicine II
  • 澳大利亚
    • Queensland
      • Maroochydore、Queensland、澳大利亚、4558
        • Rheumatology Research Unit
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294
        • University of Alabama at Birmingham
      • Huntsville、Alabama、美国、35801
        • Rheumatology Associates of North Alabama, PC
    • Arizona
      • Gilbert、Arizona、美国、85234
        • Arthrocare, Arthritiscare & Research, PC
    • Arkansas
      • Hot Springs、Arkansas、美国、71913
        • CHI St. Vincent Medical Group Hot Springs
    • California
      • Los Angeles、California、美国、90095
        • UCLA David Geffen School of Medicine
      • Los Angeles、California、美国、90095
        • UCLA Clinical & Translational Research Center
      • Palm Desert、California、美国、92260
        • Desert Medical Advances
    • Connecticut
      • Trumbull、Connecticut、美国、06611
        • New England Research Associates, LLC
    • Delaware
      • Newark、Delaware、美国、19711
        • QPS Labs
    • Florida
      • Tampa、Florida、美国、33612
        • University of South Florida - College of Medicine Carol and Frank Morsani Center
    • Illinois
      • Maywood、Illinois、美国、60153
        • Loyola University Medical Center
      • Morton Grove、Illinois、美国、60053
        • Illnois Bone & Joint Institute
    • Indiana
      • Indianapolis、Indiana、美国、46214
        • Covance Central Laboratory Services
    • Kentucky
      • Lexington、Kentucky、美国、40504
        • Bluegrass Community Research, Inc.
    • Maryland
      • Cumberland、Maryland、美国、21502
        • Klein & Associates, M.D., P.A.
    • Massachusetts
      • Worcester、Massachusetts、美国、01605
        • Clinical Pharmacology Study Group
    • Michigan
      • Battle Creek、Michigan、美国、49015
        • Bronson Internal Medicine and Rheumatology
      • Lansing、Michigan、美国、48910
        • Justus J. Fiechtner, MD, PC
    • Nevada
      • Las Vegas、Nevada、美国、89102
        • University of Nevada School of Medicine
    • New Hampshire
      • Lebanon、New Hampshire、美国、03756
        • Dartmouth - Hitchcock Medical Center
    • New York
      • Great Neck、New York、美国、11021
        • North Shore-LIJ Health System - Division of Rheumatology and Allergy-Clinical
    • North Carolina
      • Hickory、North Carolina、美国、28602
        • PMG Research of Hickory LLC
      • Hickory、North Carolina、美国、28602
        • PMG Research of Hickory, LLC
    • Ohio
      • Cincinnati、Ohio、美国、45219
        • Cincinnati Rheumatic Disease Study Group
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73103
        • Health Research of Oklahoma
    • Pennsylvania
      • Duncansville、Pennsylvania、美国、16635
        • Altoona Center for Clinical Research
      • Philadelphia、Pennsylvania、美国、19152
        • The Arthritis Group
      • Wyomissing、Pennsylvania、美国、19610
        • Clinical Research Center of Reading, LLC
    • Tennessee
      • Hixson、Tennessee、美国、37343
        • Arthritis Associates, PLLC
      • Jackson、Tennessee、美国、38305
        • Arthritis Clinic
      • Jackson、Tennessee、美国、38305
        • West Tennessee Research Institute
    • Texas
      • Dallas、Texas、美国、75231
        • Metroplex Clinical Research Center
      • Houston、Texas、美国、77054
        • Apocell, Inc
      • Mesquite、Texas、美国、75150
        • Southwest Rheumatology Research, LLC
  • 英国
      • Leeds、英国、LS7 1NR
        • Division of Rheumatic & Musculoskeletal Diseases

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Participated for a minimum of 16 weeks after the initiation of the last course of treatment in a previous rheumatoid arthritis study in the rituximab-Pfizer program within the past 2 months.

Exclusion Criteria:

  • Investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the study.
  • Initiated treatment with investigational agents or other biologics (including Rituxan and MabThera) since participating in a previous rheumatoid arthritis study in the rituximab-Pfizer program.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Rituximab-Pfizer
生物：Rituximab-Pfizer (PF-05280586) x 3 courses
1000 mg intravenous infusion [IV] on Days 1 and 15 of each 24 week treatment course for up to 3 treatment courses
有源比较器：Rituximab-EU+Rituximab-Pfizer
Subjects will receive Rituximab-EU x 1 course followed by Rituximab-Pfizer x 2 courses.
生物：Rituximab-EU+ Rituximab-Pfizer x 2 Courses
Subjects will receive Rituximab-EU x 1 course followed by Rituximab-Pfizer x 2 courses. 1000 mg IV infusion of Rituximab-EU on Days 1 and 15 of a 24 week treatment course followed by 1000 mg IV infusion of PF-05280586 on Days 1 and 15 of each 24 week course for up to 2 additional treatment courses
有源比较器：Rituximab-US+Rituximab-Pfizer
Subjects will receive Rituximab-US x 1 course followed by Rituximab-Pfizer x 2 courses.
生物：Rituximab-US + Rituximab-Pfizer x 2 Courses
Subjects will receive Rituximab-US x 1 course followed by Rituximab-Pfizer x 2 courses. 1000 mg IV infusion of Rituximab-US on Days 1 and 15 of a 24 week treatment course followed by 1000 mg IV infusion of PF-05280586 on Days 1 and 15 of each 24 week course for up to 2 additional treatment courses

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay
大体时间：Course 1 (C1) Overall, Course 2 (C2) Overall, Course 3 (C3) Overall, and All Courses Overall.
Serum samples were collected to determine the presence of ADA using two validated assays, one specific for PF-05280586 and one specific for the licensed drug products. For participants assigned to PF-05280586 in Study B3281001, blood samples were screened for ADA using the assay specific to PF-05280586; if the blood samples were confirmed to be positive (+ve) for ADA against PF-05280586, the samples were also analyzed using the assay specific for the licensed drug products to assess cross-reactivity of the ADA. For participants assigned to the licensed products in Study B3281001, blood samples were screened for ADA using both assays in order to assess any product-specific ADA and/or cross-reactivity for the transition from the licensed products to PF-05280586.
Course 1 (C1) Overall, Course 2 (C2) Overall, Course 3 (C3) Overall, and All Courses Overall.
Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay
大体时间：Course 1 Overall, Course 2 Overall, Course 3 Overall, and All Courses Overall.
Serum samples were collected to determine the presence of ADA using two validated assays, one specific for PF-05280586 and one specific for the licensed drug products. For participants assigned to PF-05280586 in Study B3281001, blood samples were screened for ADA using the assay specific to PF-05280586; if the blood samples were confirmed to be positive for ADA against PF-05280586, the samples were also analyzed using the assay specific for the licensed drug products to assess cross-reactivity of the ADA. For participants assigned to the licensed products in Study B3281001, blood samples were screened for ADA using both assays in order to assess any product-specific ADA and/or cross-reactivity for the transition from the licensed products to PF-05280586.
Course 1 Overall, Course 2 Overall, Course 3 Overall, and All Courses Overall.
Percentage of Participants by Neutralizing Antibody (Nab) Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay
大体时间：Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).
Blood samples that were confirmed as positive for ADA were further evaluated for Nab using validated assays - None of the ADA samples tested positive for NAb.
Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).
Percentage of Participants by Nab Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay Using Anti-Rituximab NAb Assay
大体时间：Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).
Blood samples that were confirmed as positive for ADA were further evaluated for Nab using validated assays. - None of the ADA samples tested positive for NAb.
Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).
Mean Rituximab Serum Trough Concentrations
大体时间：Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3), Follow up Months 3, 6, 9, and 12. Course 3/Week 25 is End of Treatment (EOT).
Serum samples for determination of drug concentrations were collected pre-dose concurrent with ADA sample collection. Drug concentrations in the samples were determined using a validated assay.
Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3), Follow up Months 3, 6, 9, and 12. Course 3/Week 25 is End of Treatment (EOT).
Cluster of Differentiation 19 (CD19+) B Cell Count
大体时间：Weeks 1, 6, 13, and 25 (Course 1 and Course 2), Weeks 1, 13, 25 (Course 3), and Follow up Months 3, 6, and 9.
Blood samples were assayed for CD19+ B-cell counts using laser scanning cytometry.
Weeks 1, 6, 13, and 25 (Course 1 and Course 2), Weeks 1, 13, 25 (Course 3), and Follow up Months 3, 6, and 9.
Circulating Immunoglobulin G (IgG) Concentrations
大体时间：Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).
Blood samples for immunoglobulin assessments were obtained to determine IgG levels in serum.
Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).
Circulating Immunoglobulin M (IgM) Concentrations
大体时间：Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).
Blood samples for immunoglobulin assessments were obtained to determine IgM levels in serum.
Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).
Circulating Rheumatoid Factor (RF) Concentrations
大体时间：Week 1 and 25 (Course 1, Course 2, and Course 3).
RF is the auto-antibody directed against IgG. Blood samples were obtained to determine RF levels in serum.
Week 1 and 25 (Course 1, Course 2, and Course 3).
Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement
大体时间：Week 1 and 25 (Course 1, Course 2, and Course 3).
Blood samples were obtained to determine anti-CCP and compliment levels in serum.
Week 1 and 25 (Course 1, Course 2, and Course 3).
Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1
大体时间：Baseline B3281001, Week 1, 6, 13, and 25 (Course 1).
The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log [ln] (CRP [milligrams per liter, mg/L] +1) + 0.014 (global assessment of health [GH]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity.
Baseline B3281001, Week 1, 6, 13, and 25 (Course 1).
Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2
大体时间：Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2).
The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log [ln] (CRP [milligrams per liter, mg/L] +1) + 0.014 (global assessment of health [GH]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity.
Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2).
Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3
大体时间：Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log [ln] (CRP [milligrams per liter, mg/L] +1) + 0.014 (global assessment of health [GH]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity.
Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1
大体时间：Week 1, 6, 13, and 25 (Course 1).
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline >0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline >0.6 with present DAS28 >3.2 and ≤5.1 or change from baseline >1.2 with present DAS28 >5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or change from baseline ≤1.2 with present DAS28 >5.1.
Week 1, 6, 13, and 25 (Course 1).
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2
大体时间：Week 1, 6, 13, and 25 (Course 1 and Course 2).
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline >0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline >0.6 with present DAS28 >3.2 and ≤5.1 or change from baseline >1.2 with present DAS28 >5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or change from baseline ≤1.2 with present DAS28 >5.1.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3
大体时间：Week 1, 6, 13, and 25 (Course 1 and Course 2) and Week 1, 13, and 25 (Course 3).
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline >0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline >0.6 with present DAS28 >3.2 and ≤5.1 or change from baseline >1.2 with present DAS28 >5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or change from baseline ≤1.2 with present DAS28 >5.1.
Week 1, 6, 13, and 25 (Course 1 and Course 2) and Week 1, 13, and 25 (Course 3).
Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1
大体时间：Week 1, 6, 13, and 25 (Course 1).
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity.
Week 1, 6, 13, and 25 (Course 1).
Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2
大体时间：Week 1, 6, 13, and 25 (Course 1 and Course 2).
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3
大体时间：Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity.
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1
大体时间：Week 1, 6, 13, and 25 (Course 1).
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP <2.6 implied remission.
Week 1, 6, 13, and 25 (Course 1).
Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2
大体时间：Week 1, 6, 13, and 25 (Course 1 and Course 2).
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP <2.6 implied remission.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3
大体时间：Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP <2.6 implied remission.
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1
大体时间：Week 1, 6, 13, and 25 (Course 1).
ACR20 response: ≥ 20 percent (%) improvement in tender/painful joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.
Week 1, 6, 13, and 25 (Course 1).
Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2
大体时间：Week 1, 6, 13, and 25 (Course 1 and Course 2).
ACR20 response: ≥ 20 percent (%) improvement in tender/painful joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3
大体时间：Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
ACR20 response: ≥ 20 percent (%) improvement in tender/painful joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1
大体时间：Week 1, 6, 13, and 25 (Course 1).
ACR50 response: ≥50% improvement in tender/painful joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
Week 1, 6, 13, and 25 (Course 1).
Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2
大体时间：Week 1, 6, 13, and 25 (Course 1 and Course 2).
ACR50 response: ≥50% improvement in tender/painful joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3
大体时间：Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
ACR50 response: ≥50% improvement in tender/painful joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1
大体时间：Week 1, 6, 13, and 25 (Course 1).
ACR70 response: ≥70% improvement in tender/painful joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
Week 1, 6, 13, and 25 (Course 1).
Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2
大体时间：Week 1, 6, 13, and 25 (Course 1 and Course 2).
ACR70 response: ≥70% improvement in tender/painful joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3
大体时间：Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
ACR70 response: ≥70% improvement in tender/painful joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1
大体时间：Screening, Week 1, 6, 13, and 25 (Course 1).
Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. 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 be assessed.
Screening, Week 1, 6, 13, and 25 (Course 1).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2
大体时间：Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).
Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. 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 be assessed.
Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3
大体时间：Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).
Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. 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 be assessed.
Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1
大体时间：Screening, Week 1, 6, 13, and 25 (Course 1).
Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
Screening, Week 1, 6, 13, and 25 (Course 1).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2
大体时间：Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).
Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3
大体时间：Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).
Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1
大体时间：Week 1, 6, 13, and 25 (Course 1).
Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Week 1, 6, 13, and 25 (Course 1).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2
大体时间：Week 1, 6, 13, and 25 (Course 1 and Course 2).
Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3
大体时间：Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1
大体时间：Week 1, 6, 13, and 25 (Course 1).
Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor).
Week 1, 6, 13, and 25 (Course 1).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2
大体时间：Week 1, 6, 13, and 25 (Course 1 and Course 2).
Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor).
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3
大体时间：Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor).
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1
大体时间：Week 1, 6, 13, and 25 (Course 1).
The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).
Week 1, 6, 13, and 25 (Course 1).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2
大体时间：Week 1, 6, 13, and 25 (Course 1 and Course 2).
The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3
大体时间：Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1
大体时间：Week 1, 6, 13, and 25 (Course 1).

HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.

Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.

Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale.
Week 1, 6, 13, and 25 (Course 1).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2
大体时间：Week 1, 6, 13, and 25 (Course 1 and Course 2).

HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.

Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.

Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3
大体时间：Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).

HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.

Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.

Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale.
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Outcome Measure Using HAQ-DI - by the End of Course 1
大体时间：Week 1, 6, 13, and 25 (Course 1).

HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.

Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.

Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3.
Week 1, 6, 13, and 25 (Course 1).
Outcome Measure Using HAQ-DI - by the End of Course 2
大体时间：Week 1, 6, 13, and 25 (Course 1 and Course 2).

HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.

Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.

Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Outcome Measure Using HAQ-DI - by the End of Course 3
大体时间：Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).

HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.

Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.

Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3.
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).

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研究主要日期

学习开始 (实际的)

2012年8月16日

初级完成 (实际的)

2016年3月14日

研究完成 (实际的)

2016年3月14日

研究注册日期

首次提交

2012年7月6日

首先提交符合 QC 标准的

2012年7月16日

首次发布 (估计)

2012年7月18日

研究记录更新

最后更新发布 (实际的)

2019年1月29日

上次提交的符合 QC 标准的更新

2019年1月8日

最后验证

2019年1月1日

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其他研究编号

  • B3281004
  • ICON 9002/0101
  • 2012-003223-38 (EudraCT编号)

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