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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Rituximab-Pfizer (PF-05280586) x 3 courses

Rituximab-EU+ Rituximab-Pfizer x 2 Courses

Rituximab-US + Rituximab-Pfizer x 2 Courses

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring extension trial, rheumatoid arthritis, rituximab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Alabama at Birmingham
Rheumatology Associates of North Alabama, PC
Arthrocare, Arthritiscare & Research, PC
CHI St. Vincent Medical Group Hot Springs
UCLA Clinical & Translational Research Center
UCLA David Geffen School of Medicine
Desert Medical Advances
New England Research Associates, LLC
QPS Labs
University of South Florida - College of Medicine Carol and Frank Morsani Center
Loyola University Medical Center
Illnois Bone & Joint Institute
Covance Central Laboratory Services
Bluegrass Community Research, Inc.
Klein & Associates, M.D., P.A.
Clinical Pharmacology Study Group
Bronson Internal Medicine and Rheumatology
Justus J. Fiechtner, MD, PC
University of Nevada School of Medicine
Dartmouth - Hitchcock Medical Center
North Shore-LIJ Health System - Division of Rheumatology and Allergy-Clinical
PMG Research of Hickory LLC
PMG Research of Hickory, LLC
Cincinnati Rheumatic Disease Study Group
Health Research of Oklahoma
Altoona Center for Clinical Research
The Arthritis Group
Clinical Research Center of Reading, LLC
Arthritis Associates, PLLC
Arthritis Clinic
West Tennessee Research Institute
Metroplex Clinical Research Center
Apocell, Inc
Southwest Rheumatology Research, LLC
Rheumatology Research Unit
Clinique Medicale du Phare (ECG Only)
Centre de Rhumatologie de l'Est du Quebec
Pharmacie Matte et Petit
Centre de Recherche Saint-Louis
IPS Rodrigo Botero S.A.S.
Rodrigo Botero S.A.S.
Clínica Medellín S.A. Sede Centro
Mix Supplier S.A.
Centro de Reumatologia y Ortopedia
Clinica de La Costa Ltda.
Congregación de las Hermanas Franciscanas Misioneras de María Auxiliadora-Clinica La Asuncion
IPS Centro Integral de Reumatologia del Caribe, CIRCARIBE S.A.S.
IPS Centro Integral De Reumatologia del Caribe, CIRCARIBE S.A.S
Organizacion Clinica General Del Norte S.A.
Schlosspark-Klinik GmbH, Internal Medicine II
The Chaim Sheba Medical Center
C.T. Scanner de Mexico, S.A. de C.V. (CT ONLY)
CLIDITER, S.A de C.V.
Hospital Angeles Clinica Londres
Hospital Bernardette (Emergencies)
Private Office
Hospital Angeles, Centro Medico del Potosi
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
LLC Scientific and Research Medical Complex "Your Health"
State Institution of Healthcare "Regional Clinical Hospital for Wars' Veterans"
LLC Consulting and Diagnostic Rheumatological Center "Healthy Joints"
State Budget Institution of Healthcare "Samara Regional Clinical Hospital named after V.D. Seredavin
State Institution of Healthcare "Samara Regional Clinical Hospital named after V.D. Seredavin"
AVA-PETER Ltd.
Local Ethics Committee of LLC AVA-PETER
St. Petersburg State Healthcare Institution "Clinical Rheumatology Hospital 25"
"AVA-PETER" Ltd - Affiliate Address
Laboratory of LLC AVA-PETER
Panorama Medical Centre - Room 136
Dr. Jan Fourie Medical Centre
Division of Rheumatic & Musculoskeletal Diseases

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Rituximab-Pfizer

Rituximab-EU+Rituximab-Pfizer

Rituximab-US+Rituximab-Pfizer

Arm Description

Subjects will receive Rituximab-EU x 1 course followed by Rituximab-Pfizer x 2 courses.

Subjects will receive Rituximab-US x 1 course followed by Rituximab-Pfizer x 2 courses.

Outcomes

Primary Outcome Measures

Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay

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.

Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay

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.

Percentage of Participants by Neutralizing Antibody (Nab) Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay

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.

Percentage of Participants by Nab Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay Using Anti-Rituximab NAb Assay

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.

Mean Rituximab Serum Trough Concentrations

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.

Cluster of Differentiation 19 (CD19+) B Cell Count

Blood samples were assayed for CD19+ B-cell counts using laser scanning cytometry.

Circulating Immunoglobulin G (IgG) Concentrations

Blood samples for immunoglobulin assessments were obtained to determine IgG levels in serum.

Circulating Immunoglobulin M (IgM) Concentrations

Blood samples for immunoglobulin assessments were obtained to determine IgM levels in serum.

Circulating Rheumatoid Factor (RF) Concentrations

RF is the auto-antibody directed against IgG. Blood samples were obtained to determine RF levels in serum.

Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement

Blood samples were obtained to determine anti-CCP and compliment levels in serum.

Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of 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.

Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2

Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3

Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of 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.

Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2

Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3

Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of 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.

Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2

Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3

Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1

Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2

Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3

Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of 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.

Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2

Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3

Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of 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.

Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2

Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3

Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of 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.

Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2

Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of 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

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.

Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of 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

Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of 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.

Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2

Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of 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

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.

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

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

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

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).

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

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

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

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).

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

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

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

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.

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

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

Outcome Measure Using HAQ-DI - by the End of 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.

Outcome Measure Using HAQ-DI - by the End of 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.

Outcome Measure Using HAQ-DI - by the End of 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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01643928

First Posted

July 6, 2012

Last Updated

January 8, 2019

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01643928

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

August 16, 2012 (Actual)

Primary Completion Date

March 14, 2016 (Actual)

Study Completion Date

March 14, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

extension trial, rheumatoid arthritis, rituximab

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

185 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rituximab-Pfizer

Arm Type

Experimental

Arm Title

Rituximab-EU+Rituximab-Pfizer

Arm Type

Active Comparator

Arm Description

Subjects will receive Rituximab-EU x 1 course followed by Rituximab-Pfizer x 2 courses.

Arm Title

Rituximab-US+Rituximab-Pfizer

Arm Type

Active Comparator

Arm Description

Subjects will receive Rituximab-US x 1 course followed by Rituximab-Pfizer x 2 courses.

Intervention Type

Biological

Intervention Name(s)

Rituximab-Pfizer (PF-05280586) x 3 courses

Intervention Description

1000 mg intravenous infusion [IV] on Days 1 and 15 of each 24 week treatment course for up to 3 treatment courses

Intervention Type

Biological

Intervention Name(s)

Rituximab-EU+ Rituximab-Pfizer x 2 Courses

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Rituximab-US + Rituximab-Pfizer x 2 Courses

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay

Description

Time Frame

Course 1 (C1) Overall, Course 2 (C2) Overall, Course 3 (C3) Overall, and All Courses Overall.

Title

Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay

Description

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.

Time Frame

Course 1 Overall, Course 2 Overall, Course 3 Overall, and All Courses Overall.

Title

Percentage of Participants by Neutralizing Antibody (Nab) Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay

Description

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.

Time Frame

Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).

Title

Percentage of Participants by Nab Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay Using Anti-Rituximab NAb Assay

Description

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.

Time Frame

Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).

Title

Mean Rituximab Serum Trough Concentrations

Description

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.

Time Frame

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).

Title

Cluster of Differentiation 19 (CD19+) B Cell Count

Description

Blood samples were assayed for CD19+ B-cell counts using laser scanning cytometry.

Time Frame

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.

Title

Circulating Immunoglobulin G (IgG) Concentrations

Description

Blood samples for immunoglobulin assessments were obtained to determine IgG levels in serum.

Time Frame

Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).

Title

Circulating Immunoglobulin M (IgM) Concentrations

Description

Blood samples for immunoglobulin assessments were obtained to determine IgM levels in serum.

Time Frame

Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).

Title

Circulating Rheumatoid Factor (RF) Concentrations

Description

RF is the auto-antibody directed against IgG. Blood samples were obtained to determine RF levels in serum.

Time Frame

Week 1 and 25 (Course 1, Course 2, and Course 3).

Title

Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement

Description

Blood samples were obtained to determine anti-CCP and compliment levels in serum.

Time Frame

Week 1 and 25 (Course 1, Course 2, and Course 3).

Title

Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1

Description

Time Frame

Baseline B3281001, Week 1, 6, 13, and 25 (Course 1).

Title

Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2

Description

Time Frame

Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2).

Title

Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3

Description

Time Frame

Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).

Title

Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1).

Title

Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1 and Course 2).

Title

Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1 and Course 2) and Week 1, 13, and 25 (Course 3).

Title

Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1).

Title

Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1 and Course 2).

Title

Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).

Title

Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1).

Title

Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1 and Course 2).

Title

Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).

Title

Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1).

Title

Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1 and Course 2).

Title

Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).

Title

Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1).

Title

Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1 and Course 2).

Title

Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).

Title

Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1).

Title

Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1 and Course 2).

Title

Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).

Title

Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1

Description

Time Frame

Screening, Week 1, 6, 13, and 25 (Course 1).

Title

Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2

Description

Time Frame

Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).

Title

Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3

Description

Time Frame

Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).

Title

Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1

Description

Time Frame

Screening, Week 1, 6, 13, and 25 (Course 1).

Title

Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2

Description

Time Frame

Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).

Title

Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3

Description

Time Frame

Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).

Title

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

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1).

Title

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

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1 and Course 2).

Title

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

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).

Title

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

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1).

Title

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

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1 and Course 2).

Title

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

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).

Title

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

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1).

Title

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

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1 and Course 2).

Title

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

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).

Title

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

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1).

Title

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

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1 and Course 2).

Title

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

Description

Time Frame

Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).

Title

Outcome Measure Using HAQ-DI - by the End of Course 1

Description

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.

Time Frame

Week 1, 6, 13, and 25 (Course 1).

Title

Outcome Measure Using HAQ-DI - by the End of Course 2

Description

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.

Time Frame

Week 1, 6, 13, and 25 (Course 1 and Course 2).

Title

Outcome Measure Using HAQ-DI - by the End of Course 3

Description

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.

Time Frame

Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Rheumatology Associates of North Alabama, PC

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Arthrocare, Arthritiscare & Research, PC

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85234

Country

United States

Facility Name

CHI St. Vincent Medical Group Hot Springs

City

Hot Springs

State/Province

Arkansas

ZIP/Postal Code

71913

Country

United States

Facility Name

UCLA Clinical & Translational Research Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

UCLA David Geffen School of Medicine

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Desert Medical Advances

City

Palm Desert

State/Province

California

ZIP/Postal Code

92260

Country

United States

Facility Name

New England Research Associates, LLC

City

Trumbull

State/Province

Connecticut

ZIP/Postal Code

06611

Country

United States

Facility Name

QPS Labs

City

Newark

State/Province

Delaware

ZIP/Postal Code

19711

Country

United States

Facility Name

University of South Florida - College of Medicine Carol and Frank Morsani Center

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Loyola University Medical Center

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Facility Name

Illnois Bone & Joint Institute

City

Morton Grove

State/Province

Illinois

ZIP/Postal Code

60053

Country

United States

Facility Name

Covance Central Laboratory Services

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46214

Country

United States

Facility Name

Bluegrass Community Research, Inc.

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40504

Country

United States

Facility Name

Klein & Associates, M.D., P.A.

City

Cumberland

State/Province

Maryland

ZIP/Postal Code

21502

Country

United States

Facility Name

Clinical Pharmacology Study Group

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

Country

United States

Facility Name

Bronson Internal Medicine and Rheumatology

City

Battle Creek

State/Province

Michigan

ZIP/Postal Code

49015

Country

United States

Facility Name

Justus J. Fiechtner, MD, PC

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48910

Country

United States

Facility Name

University of Nevada School of Medicine

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89102

Country

United States

Facility Name

Dartmouth - Hitchcock Medical Center

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

North Shore-LIJ Health System - Division of Rheumatology and Allergy-Clinical

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

PMG Research of Hickory LLC

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28602

Country

United States

Facility Name

PMG Research of Hickory, LLC

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28602

Country

United States

Facility Name

Cincinnati Rheumatic Disease Study Group

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Health Research of Oklahoma

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

The Arthritis Group

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19152

Country

United States

Facility Name

Clinical Research Center of Reading, LLC

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

Arthritis Associates, PLLC

City

Hixson

State/Province

Tennessee

ZIP/Postal Code

37343

Country

United States

Facility Name

Arthritis Clinic

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

West Tennessee Research Institute

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

Metroplex Clinical Research Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Apocell, Inc

City

Houston

State/Province

Texas

ZIP/Postal Code

77054

Country

United States

Facility Name

Southwest Rheumatology Research, LLC

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75150

Country

United States

Facility Name

Rheumatology Research Unit

City

Maroochydore

State/Province

Queensland

ZIP/Postal Code

4558

Country

Australia

Facility Name

Clinique Medicale du Phare (ECG Only)

City

Rimouski

State/Province

Quebec

ZIP/Postal Code

G5L 1J5

Country

Canada

Facility Name

Centre de Rhumatologie de l'Est du Quebec

City

Rimouski

State/Province

Quebec

ZIP/Postal Code

G5L 8W1

Country

Canada

Facility Name

Pharmacie Matte et Petit

City

Quebec

ZIP/Postal Code

G1V 3M7

Country

Canada

Facility Name

Centre de Recherche Saint-Louis

City

Quebec

ZIP/Postal Code

G1W 4R4

Country

Canada

Facility Name

IPS Rodrigo Botero S.A.S.

City

Medellin

State/Province

Antioquia

Country

Colombia

Facility Name

Rodrigo Botero S.A.S.

City

Medellin

State/Province

Antioquia

Country

Colombia

Facility Name

Clínica Medellín S.A. Sede Centro

City

Medellín

State/Province

Antioquia

Country

Colombia

Facility Name

Mix Supplier S.A.

City

Medellín

State/Province

Antioquia

Country

Colombia

Facility Name

Centro de Reumatologia y Ortopedia

City

Barranquilla

State/Province

Atlantico

Country

Colombia

Facility Name

Clinica de La Costa Ltda.

City

Barranquilla

State/Province

Atlantico

Country

Colombia

Facility Name

Congregación de las Hermanas Franciscanas Misioneras de María Auxiliadora-Clinica La Asuncion

City

Barranquilla

State/Province

Atlantico

Country

Colombia

Facility Name

IPS Centro Integral de Reumatologia del Caribe, CIRCARIBE S.A.S.

City

Barranquilla

State/Province

Atlantico

Country

Colombia

Facility Name

IPS Centro Integral De Reumatologia del Caribe, CIRCARIBE S.A.S

City

Barranquilla

State/Province

Atlantico

Country

Colombia

Facility Name

Organizacion Clinica General Del Norte S.A.

City

Barranquilla

State/Province

Atlantico

Country

Colombia

Facility Name

Schlosspark-Klinik GmbH, Internal Medicine II

City

Berlin

ZIP/Postal Code

14059

Country

Germany

Facility Name

The Chaim Sheba Medical Center

City

Tel Hashomer

ZIP/Postal Code

5262000

Country

Israel

Facility Name

C.T. Scanner de Mexico, S.A. de C.V. (CT ONLY)

City

Mexico City

State/Province

Distrito Federal

ZIP/Postal Code

06700

Country

Mexico

Facility Name

CLIDITER, S.A de C.V.

City

Mexico City

State/Province

Distrito Federal

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Hospital Angeles Clinica Londres

City

Mexico City

State/Province

Distrito Federal

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Hospital Bernardette (Emergencies)

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44200

Country

Mexico

Facility Name

Private Office

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44650

Country

Mexico

Facility Name

Hospital Angeles, Centro Medico del Potosi

City

San Luis Potosi

ZIP/Postal Code

78200

Country

Mexico

Facility Name

Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.

City

San Luis Potosi

ZIP/Postal Code

78213

Country

Mexico

Facility Name

LLC Scientific and Research Medical Complex "Your Health"

City

Kazan

State/Province

Republic OF Tatarstan

ZIP/Postal Code

420103

Country

Russian Federation

Facility Name

State Institution of Healthcare "Regional Clinical Hospital for Wars' Veterans"

City

Kemerovo

ZIP/Postal Code

650000

Country

Russian Federation

Facility Name

LLC Consulting and Diagnostic Rheumatological Center "Healthy Joints"

City

Novosibirsk

ZIP/Postal Code

630099

Country

Russian Federation

Facility Name

State Budget Institution of Healthcare "Samara Regional Clinical Hospital named after V.D. Seredavin

City

Samara

ZIP/Postal Code

443095

Country

Russian Federation

Facility Name

State Institution of Healthcare "Samara Regional Clinical Hospital named after V.D. Seredavin"

City

Samara

ZIP/Postal Code

443095

Country

Russian Federation

Facility Name

AVA-PETER Ltd.

City

St Petersburg

ZIP/Postal Code

191014

Country

Russian Federation

Facility Name

Local Ethics Committee of LLC AVA-PETER

City

St Petersburg

ZIP/Postal Code

191025

Country

Russian Federation

Facility Name

St. Petersburg State Healthcare Institution "Clinical Rheumatology Hospital 25"

City

St. Petersburg

ZIP/Postal Code

190068

Country

Russian Federation

Facility Name

"AVA-PETER" Ltd - Affiliate Address

City

St. Petersburg

ZIP/Postal Code

191014

Country

Russian Federation

Facility Name

Laboratory of LLC AVA-PETER

City

St. Petersburg

Country

Russian Federation

Facility Name

Panorama Medical Centre - Room 136

City

Cape Town

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Dr. Jan Fourie Medical Centre

City

KwaZulu Natal

ZIP/Postal Code

3000

Country

South Africa

Facility Name

Division of Rheumatic & Musculoskeletal Diseases

City

Leeds

ZIP/Postal Code

LS7 1NR

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Citations:

PubMed Identifier

29692005

Citation

Cohen SB, Burgos-Vargas R, Emery P, Jin B, Cronenberger C, Vazquez-Abad MD. Extension Study of PF-05280586, a Potential Rituximab Biosimilar, Versus Rituximab in Subjects With Active Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2018 Nov;70(11):1598-1606. doi: 10.1002/acr.23586.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3281004&StudyName=Rheumatoid%20Arthritis%20Extension%20Trial%20For%20%20Subjects%20Who%20Have%20Participated%20In%20Other%20PF-05280586%20Trials%20%28REFLECTIONS%20B328-04%29%20

Description

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

Learn more about this trial

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

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