A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01) (REFLECTIONS)

A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES

In this study, patients with moderate to severe rheumatoid arthritis who are being treated with methotrexate will receive 2 intravenous treatments with either PF-05280586 or Rituxan (Rituximab) or MabThera (Rituximab). During the course of the study, the effects of the drugs will be assessed by sampling the levels of drug in the blood, blood cell counts, and by comparing these levels among the different treatments. Safety, tolerability and immunologic response also will be evaluated throughout.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Biological: PF-05280586; Biological: MabThera; Biological: Rituxan

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Maroochydore, Queensland, Australia, 4558
      • Rheumatology Research Unit
  • South Australia
    • Woodville South, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital, Department of Rheumatology
  • Victoria
    • Fitzroy, Victoria, Australia, 03065
      • St. Vincent's Hospital (Melbourne)
• Canada
  • Quebec, Canada, G1W 4R4
    • Centre de Rhumatologie St-Louis
  • Quebec, Canada, G1V 3M7
    • Pharmacie Matte et Petit
  • Quebec
    • Rimouski, Quebec, Canada, G5L 8W1
      • Centre de Rhumatologie de l'Est du Quebec
    • Rimouski, Quebec, Canada, G5L IJ5
      • Clinique Medicale du Phare
    • Trois-Rivieres, Quebec, Canada, G8Z 1Y2
      • Centre de Recherche Musculo-Squelettique
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia
      • Rodrigo Botero S.A.S.
    • Medellin, Antioquia, Colombia
      • Clinica Medellin S.A Sede Centro
    • Medellin, Antioquia, Colombia
      • Mix Supplier S.A
  • Atlantico
    • Barranquilla, Atlantico, Colombia
      • Cediul S.A.
    • Barranquilla, Atlantico, Colombia
      • Clinica Bonnadona - Prevenir S.A.
    • Barranquilla, Atlantico, Colombia
      • Clinica de la Costa Ltdz.
    • Barranquilla, Atlantico, Colombia
      • IPS Centro Integral de Reumatologia del Cairbe, CIRCARIBE S.A.S.
    • Barranquilla, Atlantico, Colombia
      • Sabbag Radiologos Ltda.
  • Atlántico
    • Barranquilla, Atlántico, Colombia
      • Centro de Reumatologia y Ortopedia
    • Barranquilla, Colombia, Atlántico, Colombia
      • Cerid S.A.
    • Barranquilla, Colombia, Atlántico, Colombia
      • Congregacion de las Hemanas Franciscanas Misioneras de Maria Auxiliadora - Clinica La Asuncion
    • Barranquilla, Colombia, Atlántico, Colombia
      • IPS Clinica General del Norte S.A.
• Germany
  • Berlin, Germany, 14059
    • Schlosspark-Klinik GmbH, Internal Medicine II
• Israel
  • Ramat Gan, Israel, 52621
    • The Chaim Sheba Medical Center Department of Internal Medicine B
• Mexico
  • Durango, Mexico, 34270
    • Centro de Investigacion y Atencion Integral Durango CIAID
  • San Luis Potosi, Mexico, 78200
    • Centro de Alta Especialidad en Reumatología e Investigación del Potosí S.C.
  • D.f.
    • Mexico, D.f., Mexico, 06700
      • CLIDITER, S.A. de C.V.
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 06726
      • Private Office
• Russian Federation
  • Kemerovo, Russian Federation, 650000
    • State Institution of Healthcare "Regional Clinical Hospital for Wars' Veterans"
  • Nizhny Novgorod, Russian Federation, 603005
    • State Budgetary Institution of Healthcare of Nizhegorodskiy Region
  • Saint-Petersburg, Russian Federation, 190068
    • St. Petersburg state Healthcare lnstitution 'Clinical Rheumatology Hospital No25
  • Samara, Russian Federation, 443095
    • State Institute of Healthcare Samara Regional Clinical Hospital named after M.I.Kalinin
  • St. Petersburg, Russian Federation, 191014
    • Llc Ava-Peter
  • Tomsk, Russian Federation, 634063
    • Regional State Budget Institution of Healthcare "Tomsk Regional Clinical Hospital"
  • Novosibirsk Region
    • Novosibirsk, Novosibirsk Region, Russian Federation, 630091
      • LLC CDCR "Healthy Joints"
  • Tatarstan
    • Kazan, Tatarstan, Russian Federation, 420103
      • GBUZ City Clinical Hospital #7
• South Africa
  • Cape Town
    • Panorama, Cape Town, South Africa, 7500
      • Panorama Medical Centre
  • Kwa-zulu Natal
    • Dundee, Kwa-zulu Natal, South Africa, 3000
      • Dr. Jan Fourie Medical Centre
• United Kingdom
  • Leeds, United Kingdom, LS1 3EX
    • Pharmacy Department, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust
  • Leeds, United Kingdom, LS7 4SA
    • "The University of Leeds,
  • Leeds, United Kingdom, LS9 7TF
    • Pharmacy Dispensing - Bexley Wing - St. James's University Hospital
  • London, United Kingdom, E11 1NR
    • Whipps Cross University Hospital
  • UK
    • Leeds, UK, United Kingdom, LS9 7TF
      • Bexley Wing - St. James's University Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • University of Alabama at Bermingham
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham - Arthritis Clinical Intervention Program (ACIP) SRC 076
    • Huntsville, Alabama, United States, 35801
      • Rheumatology Associates of North Alabama, PC
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Arthrocare, Arthritis Care & Research, PC
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Mercy Clinic Hot Springs Communities
  • California
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center
    • Los Angeles, California, United States, 90095-1670
      • UCLA David Geffen School of Medicine
    • Palm Desert, California, United States, 92260
      • Desert Medical Advances
    • Rancho Mirage, California, United States, 92270
      • Advances in Medicine
  • Connecticut
    • Trumbull, Connecticut, United States, 06611
      • New England Research Assoc. LLC
  • Florida
    • Orlando, Florida, United States, 32804
      • Arthritis Associates
    • Tampa, Florida, United States, 33612
      • University of South Florida - College of Medicine, Frank and Carol Morsani Center
  • Illinois
    • Burr Ridge, Illinois, United States, 60527
      • Loyola Center for Health at Burr Ridge
    • Maywood, Illinois, United States, 60153
      • Loyola Medical Medical Center Outpatient Center
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center Pharmacy
    • Morton Grove, Illinois, United States, 60053
      • Illinois Bone and Joint Institute
    • Oakbrook Terrace, Illinois, United States, 60181
      • Loyola Center for health at Oakbrook Terrace North
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Bluegrass Community Research, Inc.
  • Maryland
    • Cumberland, Maryland, United States, 21502
      • Klein & Associates, M.D., P.A.
    • Hagerstown, Maryland, United States, 21740
      • Klein & Associates, M.D., P.A.
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Clinical Pharmacology Study Group
    • Worcester, Massachusetts, United States, 01605
      • UMass Memorial Medical Center - Memorial Campus
    • Worcester, Massachusetts, United States, 01605
      • UMass Memorial Medical Center-Rheumatology Center-Memorial Campus
  • Michigan
    • Battle Creek, Michigan, United States, 49015
      • Bronson Internal Medicine & Rheumatology
    • Lansing, Michigan, United States, 48910
      • Rheumatology/Arthritis Center
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • University of Nevada School of Medicine
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
  • New York
    • Great Neck, New York, United States, 11021
      • North Shore-LIJ Health System - Division of Rheumatology and Allergy-Clinical Immunology
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Box Arthritis & Rheumatology of the Carolinas, PLLC
    • Hickory, North Carolina, United States, 28601
      • Hickory Family Practice Associates
    • Hickory, North Carolina, United States, 28602
      • PMG Research of Hickory, LLC - PI's Main Office (Subject visit, IP Storage, Infusion, & Lab Draws)
    • Hickory, North Carolina, United States, 28602
      • PMG Research of Hickory
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Cincinnati Rheumatic Disease Study Group, Inc.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Health Research of Oklahoma
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
    • Philadelphia, Pennsylvania, United States, 19152
      • The Arthritis Group
    • Wyomissing, Pennsylvania, United States, 19610
      • Clinical Research Center of Reading, LLP
  • Tennessee
    • Hixson, Tennessee, United States, 37343
      • Arthritis Associates, PLLC
    • Jackson, Tennessee, United States, 38305
      • Arthritis Clinic
    • Jackson, Tennessee, United States, 38305
      • West Tennessee Research Institute
  • Texas
    • Dallas, Texas, United States, 75231
      • Metroplex Clinical Research Center
    • Houston, Texas, United States, 77004
      • Center For Clinical Trials Of Houston
    • Mesquite, Texas, United States, 75150
      • Southwest Rheumatology Research LLC.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Confirmed diagnosis of rheumatoid arthritis
• Meets Class I, II or III of the ACR 1991 Revised Criteria
• RA seropositivity
• Stable dose of methotrexate
• Inadequate response to TNF inhibitors

Exclusion Criteria:

• Any prior treatment with lymphocyte depleting therapies
• History of active TB infection
• Known or screen test positive for specific viruses or indicators of viral infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A - PF-05280586	Biological: PF-05280586; 1000 mg, IV on days 1 and 15
Active Comparator: B - Rituximab EU	Biological: MabThera; 1000 mg, IV on days 1 and 15
Active Comparator: C- Rituximab-US	Biological: Rituxan; 1000 mg, IV on days 1 and 15

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Serum Concentration (Cmax) of Rituximab	Cmax is the peak serum concentration of study drug (rituximab) after a dose has been administered.	Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion
AUC 0-inf of Rituximab	The AUC 0-inf refers to the concentration in serum of the drug over time. It represents the total drug exposure over time, from time 0 (the point of drug administration) extrapolated to infinity.	Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rituximab AUC From Time 0 to 2 Weeks (AUC 0-2wk)	The AUC 0-2wk refers to the concentration in serum of the drug over time. It represents the total drug exposure over time, from time 0 (the point of drug administration) to 2 weeks after drug administration.	Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion
Rituximab AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUC 0-T)	The AUC 0-T refers to the concentration in serum of the drug over time. It represents the total drug exposure over time, from time 0 (the point of drug administration) to the last measured concentration at time T.	Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion
CD19+ B-cell Count AUC From Time 0 to the Last Measurement at Time T (AUC 0-T,B-cell)	The AUC 0-T,B-cell refers to the concentration in serum of B-cells. It represents the total B-cells over time from time 0 (the point of drug administration) to the last measurement taken at time T.	Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)
Minimum Post-Baseline CD19+ B-cell Count (/uL)	The lowest CD19+ B-cell count measured in a participant's blood post-baseline.	Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)
Time to Minimum Post-Baseline CD19+ B-cell Count (Weeks)	The amount of time in weeks from baseline to the lowest observed CD19+ B-cell count.	Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)
Duration of B-cell Depletion (τB-cell) (Days)	The τB-cell is defined as the time interval over which the B-cell count was <0.3 cells/uL or the detection limit.	Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)
Percentage of Participants With CD19+ B-cell Count Recovery	The percentage of participants with CD19+ B-cell counts which fell to <50% of Baseline value during treatment and which recovered to ≥50% of Baseline value at End of Treatment.	Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25
Area Under the CD19+ B-cell Count Concentration-time Profile (AUC 0-T, B-cell)	The AUC 0-T, B-cell refers to the CD19+ B-cell count over time. It represents the total B-cells over time, from time 0 (the point of drug administration) to the last measured count at time T.	Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)
Baseline and Change From Baseline in Circulating Immunoglobulin-M (IgM) by Visit (Grams Per Liter (g/L])	The level of IgM in serum at Baseline and the change from Baseline at each subsequent visit.	Baseline and Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21 and 25 (EOT)
Percent (%) Change From Baseline in Circulating IgM by Visit (g/L)	The percentage change from Baseline in circulating IgM by visit.	Baseline and Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21 and 25
Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response by Visit	ACR20 response: greater than or equal to (≥)20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). Non-responder imputation categorized participants as having a non-response if they did not have data available at a visit due to missing data or study discontinuation. Participants who rolled over to the extension study were not included in the non-responder imputation from that point on.	Weeks 3, 5, 9, 13, 17, 21 and 25
Percentage of Participants With ACR 70% Improvement (ACR70) Response by Visit	ACR70 response: ≥70% improvement in tender joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. Non-responder imputation categorized participants as having a non-response if they did not have data available at a visit due to missing data or study discontinuation. Participantss who rolled over to the extension study were not included in the non-responder imputation from that point on.	Weeks 3, 5, 9, 13, 17, 21 and 25 (EOT)
Percentage of Participants With ACR 50% Improvement (ACR50) Response by Visit	ACR50 response: ≥50% improvement in tender joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. Non-responder imputation categorized participants as having a non-response if they did not have data available at a visit due to missing data or study discontinuation. Participants who rolled over to the extension study were not included in the non-responder imputation from that point on.	Weeks 3, 5, 9, 13, 17, 21 and 25
Percentage of Participants by Anti-drug Antibody (ADA) Status	Presence of anti-rituximab antibodies in blood. Participants with a positive antibody status at any time during the study were defined as having overall positive antibody status; participants with a negative antibody status throughout the study were defined as having overall negative antibody status.	Days 1 up to Day 169.
Percentage of Participants With Neutralizing Antibody (NAb) in Participants With a Positive ADA by Visit		Day 1 up to Day 169
Change From Baseline in Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (DAS28-CRP)	DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP less than or equal to (≤)3.2 implied low disease activity, DAS28-CRP greater than (>)3.2 to ≤5.1 implied moderate to high disease activity, and DAS28-CRP less than (<)2.6 implied remission.	Baseline and Weeks 3, 5, 9, 13, 17, 21 and 25
Percent Change From Baseline in DAS28-CRP by Visit	DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP less than or equal to (≤)3.2 implied low disease activity, DAS28-CRP greater than (>)3.2 to ≤5.1 implied moderate to high disease activity, and DAS28-CRP less than (<)2.6 implied remission.	Baseline and Weeks 3, 5, 9, 13, 17, 21 and 25
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on Disease Activity Score Based on 28-Joint Count (DAS28) by Visit	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: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6, or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.	Weeks 3, 5, 9, 13, 17, 21 and 25
Percentage of Participants With Moderate EULAR Response Based on Disease Activity Score Based on DAS28 by Visit	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: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6, or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.	Weeks 3, 5, 9, 13, 17, 21 and 25
Percentage of Participants With No EULAR Response Based on DAS28 by Visit	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: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6, or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.	Weeks 3, 5, 9, 13, 17, 21 and 25
Percentage of Participants With Low Disease Activity Score (DAS <=3.2) by Visit	DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity. p-value of 9999 indicates p-value is not applicable.	Weeks 3, 5, 9, 13, 17, 21 and 25
Percentage of Participants With DAS Remission (DAS <2.6) by Visit	DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP <2.6 implied remission. p-value of 9999 indicates p-value is not applicable.	Weeks 3, 5, 9, 13, 17, 21 and 25
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Visit	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.	Baseline, Week 3, 5, 9, 13, 17, 21 and 25
Percent Change From Baseline in HAQ-DI Score by Visit	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.	Baseline, Week 3, 5, 9, 13, 17, 21 and 25

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Williams JH, Hutmacher MM, Zierhut ML, Becker JC, Gumbiner B, Spencer-Green G, Melia LA, Liao KH, Suster M, Yin D, Li R, Meng X. Comparative assessment of clinical response in patients with rheumatoid arthritis between PF-05280586, a proposed rituximab biosimilar, and rituximab. Br J Clin Pharmacol. 2016 Dec;82(6):1568-1579. doi: 10.1111/bcp.13094. Epub 2016 Sep 22.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2012
• Primary Completion (Actual): August 13, 2013
• Study Completion (Actual): May 7, 2014

Study Registration Dates

• First Submitted: February 1, 2012
• First Submitted That Met QC Criteria: February 2, 2012
• First Posted (Estimate): February 3, 2012

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: rheumatoid arthritis; rituximab; methotrexate; anti-TNF
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Rituximab
• Other Study ID Numbers: B3281001; ICON 9002/010; 2011-002896-40 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.