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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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

185

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Rituximab-Pfizer
生物学的：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
アクティブコンパレータ：Rituximab-EU+Rituximab-Pfizer
Subjects will receive Rituximab-EU x 1 course followed by Rituximab-Pfizer x 2 courses.
生物学的：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
アクティブコンパレータ：Rituximab-US+Rituximab-Pfizer
Subjects will receive Rituximab-US x 1 course followed by Rituximab-Pfizer x 2 courses.
生物学的：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

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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Pfizer

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2012年8月16日

一次修了 (実際)

2016年3月14日

研究の完了 (実際)

2016年3月14日

試験登録日

最初に提出

2012年7月6日

QC基準を満たした最初の提出物

2012年7月16日

最初の投稿 (見積もり)

2012年7月18日

学習記録の更新

投稿された最後の更新 (実際)

2019年1月29日

QC基準を満たした最後の更新が送信されました

2019年1月8日

最終確認日

2019年1月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

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

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はい

IPD プランの説明

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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