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Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus (BUTTERFLY)

Primary Purpose

Lupus Erythematosus, Systemic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-04236921
PF-04236921
PF-04236921
PF-04236921
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring double-blind, placebo-controlled, multicenter, dose-ranging, efficacy, safety, lupus.

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female subjects between ages of 18 and 75 years old at time of signing consent.
  • Have a clinical diagnosis of SLE according to 1997 update on the revised 1982 American College of Rheumatology (ACR) criteria.
  • Have a unequivocally positive anti-nuclear antibody (ANA) test result.
  • Active disease at screening defined by both: SLEDAI-2K score greater than or equal to 6 and BILAG Level A disease in more than or equal to 1 organ system (except renal or central nervous system) or BILAG B disease in more than or equal to 2 organ systems if no level A disease in present.

Exclusion Criteria:

  • Any prior history of treatment with PF-04236921, or anti-IL-6 agent;
  • Have received any of the following within 364 days of day 1: a biologic investigational agent other than B cell targeted therapy; required 3 or more courses of systemic corticosteroids for concomitant conditions; history of previously untreated or current evidence of active or untreated latent infection with Tuberculosis (TB), evidence of prior untreated or currently active TB by chest radiography, residing with or frequent close contact with an individual with active TB.

Sites / Locations

  • Anniston Medical Clinic, PC
  • Pinnacle Research Group, LLC
  • Achieve Clinical Research, LLC
  • Med Investigations, Inc.
  • Premier Clinical Research, LLC
  • Novo Research
  • St Mary Medical Center
  • Cedars-Sinai Medical Center
  • Wallace Rheumatic Study Center
  • UCLA Division of Rheumatology
  • UCLA Rheumatology Clinical Research Center
  • Ronald Reagan UCLA Medical Center
  • UCLA Medical Center
  • Inland Rheumatology and Osteoporosis Medical Group
  • Inland Rheumatology Clinical Trials, Inc.
  • Asthma, Allergy, Arthritis and Lung Center
  • Southeastern Arthritis Center
  • Southeastern Community Pharmacy
  • Southeastern Integrated Medical, PL, d/b/a Florida Medical Research Institute
  • Southeastern lmaging & Diagnostics
  • New Horizon Research Center
  • Arthritis Associates
  • Millennium Research
  • The Arthritis Center
  • Advent Clinical Research Centers, Inc.
  • Burnette & Silverfield, MDS PLC
  • Emory University
  • Grady Health Systems
  • Idaho Arthritis Center
  • University of Chicago Medical Center
  • Beacon Medical Group Rheumatology
  • Indiana CTSI Clinical Research Center
  • Investigational Drug Services
  • Johns Hopkins University School of Medicine
  • Johns Hopkins Outpatient Center
  • Johns Hopkins Outpatient Express Testing Center
  • Tufts Medical Center/ Center for Arthritis and Rheumatic Diseases
  • University of Michigan
  • University of Michigan Health System
  • University of Michigan Health System,
  • Henry Ford Health System (Henry Ford Medical Center)
  • Shores Rheumatology P.C
  • University of Nevada School of Medicine
  • Albuquerque Clinical Trials
  • Arthritis and Osteoporosis Medical Associates, PLLC
  • Feinstein Institute for Medical Research
  • NYU Center for Musculoskeletal Care
  • Allergy/Immunology and Rheumatology
  • The University of North Carolina Clinical and Translational Research Center
  • The University of North Carolina Hospitals Investigational Drug Services
  • The University of North Carolina at Chapel Hill
  • Joint and Muscle Medical Care
  • Box Arthritis & Rheumatology of the Carolinas, PLLC
  • Cleveland Clinic Foundation
  • Paramount Medical Research and Consulting, LLC
  • Oklahoma Medical Research Foundation
  • Clinical Research Center of Reading, LLP
  • Low Country Rheumatology, PA/Low Country Research
  • Arthritis Clinic
  • West Tennessee Research Institute
  • UT Southwestern Medical Center
  • UT Southwestern Medical Center
  • Rheumatic Disease Clinical Research Center, LLC
  • Accurate Clinical Research, Inc.
  • Southwest Rheumatology Research, LLC
  • The Seattle Arthritis Clinic
  • Tacoma Center for Arthritis Research, PS
  • Mountain State Clinical Research
  • Framingham Centro Medico
  • Instituto CAICI S.R.L.
  • Centro Medico Privado de Reumatologia
  • Centro de Educación Medica e Investigaciones Clinicas "Norberto Quirno" CEMIC
  • Centro Polivalente de Asistencia e Investigación Clínica - CER- San Juan
  • Sociedad Medica del Aparato Locomotor S.A. (SOMEAL)
  • Centro de Estudios Reumatologicos
  • Centro Medico Prosalud
  • Mix Supplier S.A.
  • Centro Integral de Reumatologia REUMALAB S.A.S.
  • Hospital Pablo Tobon Uribe
  • Centro Integral de Reumatología del Caribe CIRCARIBE SAS
  • Congregacion de Hermanas Franciscanas Misioneras de Maria Auxiliadora- Clinica Asunción
  • Organizacion Clinica General del Norte S.A.
  • Farmamix Ltda.
  • Centro Integral de Reumatologia e Inmunologia S.A.S.- CIREI S.A.S.
  • Riesgo De Fractura S.A
  • Servimed E.U
  • Farmamix Ltda.
  • Charité - Universitaetsmedizin Berlin
  • Charité University Medicine Berlin. Schlosspark-Klinik
  • Universitaetsklinikum Erlangen
  • CIRI am Klinikum der Goethe-Universitaet
  • Universitaetsklinikum Koeln
  • Universitaetsklinikum Leipzig AoeR, Department fuer Innere Medizin
  • Qualiclinic Kft.
  • Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum
  • Bekes Megyei Kepviselo-testulet Pandy Kalman Korhaz Infektologia, Hepatologia es Immunologia
  • Dong-A University Medical Center 1
  • Spitalul Clinic Republican
  • Centro de Investigacion REUMED, Clinica Anglo Americana
  • Investigaciones Clínicas SAC
  • Investigaciones Clinicas SAC
  • Unidad de Investigación en Medicina Interna y Enfermedades Críticas
  • NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska lek.med. Barbara Bazela
  • Medyczne Centrum Hetmanska - Indywidualna Specjalistyczna Praktyka Lekarska -
  • Prywatna Praktyka Lekarska Prof. UM Dr hab. med. Pawel Hrycaj
  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych
  • University of Puerto Rico
  • Division of Rheumatology, Allergy and Immunology
  • Spitalul Clinic Sf. Maria
  • Spitalul Clinic Colentina
  • Spitalul Clinic Jedetean de urgenta Cluj, Reumatologie
  • Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei"
  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

10 mg of PF-04236921

50 mg of PF-04236921

200 mg of PF-04236921

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 24
SRI components include:Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K),British Isles Lupus Assessment Group(BILAG) 2004,Physician's Global Assessment(PhGA).Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: greater than or equal to(>=) 4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (less than [<] 0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K:assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG:assesses disease extent, severity (range: A[severe] to E[no disease]). PhGA: assesses worsening in participant's general health status(range: 0[none] to 3[severe]).

Secondary Outcome Measures

Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, and 20
SRI components include:SLEDAI-2K ,BILAG 2004, PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: >=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG:assesses disease extent, severity (range: A [severe] to E [no disease]). PhGA: assesses worsening in participant's general health status(range: 0[none] to 3[severe]).
Percentage of Participants Achieving Modified Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, 20, and 24
SRI components include: modified SLEDAI-2K (SLEDAI-2K without standard parameters "Low complement" and "Leukopenia"), BILAG 2004, PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: >=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids, immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. Modified SLEDAI-2K: assesses improvement in disease activity (range: 0 to 102; higher score = higher severity). BILAG: assesses disease extent, severity (range: A [severe] to E [no disease]). PhGA: assesses worsening in participant's general health status (range: 0[none] to 3[severe]).
Percentage of Participants Achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response at Week 4, 8, 12, 16, 20, and 24
BICLA include: BILAG-2004, SLEDAI-2K, PhGA of disease activity. Participants classified as responder if they did not meet the definition of treatment failure and met all the following criteria: BILAG-2004 improvement (all A scores at baseline improved to B/C/D and all B scores improved to C or D); no worsening in disease activity (no new BILAG-2004 A scores or =<1 new B score); no worsening of total SLEDAI-2K score; no significant deterioration (<10 percent [%] worsening) in analogue PhGA. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. BILAG:assesses disease extent, severity (range: A[severe] to E[no disease]). SLEDAI-2K:assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). PhGA: assesses worsening in participant's general health status(range: 0[none] to 3[severe]).
Percentage of Participants Achieving Pre-defined Criteria for Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Components at Week 24
SRI components include: SLEDAI-2K, BILAG 2004 and PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: >=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening(<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids, immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K: assesses improvement in disease activity(range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity (range: A[severe] to E [no disease]). PhGA: assesses worsening in participant's general health status (range: 0[none] to 3[severe]). Model percent estimates reported only for 'Reduction in SLEDAI Score','No Worsening in PhGA' categories; for remaining categories, raw percentages reported
Number of Participants With Clinically Significant Laboratory Tests Results
Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. Laboratory values included Alanine Aminotransferase (ALT) [>5.0 - 10.0*Upper limit of normal range (ULN)], Albumin [<26-20 gram per liter (g/L)/ <20 g/L], Amylase [>2.0 - 5.0*ULN], Aspartate Aminotransferase (AST) [>5.0 - 10.0*ULN], Creatine Kinase (CK) [>5.0 - 10.0* ULN/ >10.0*ULN], Glucose (Hyperglycemia) [>13.9 - 27.8 millimoles/liter (mmol/L)], Hemoglobin (HGB) [<80 - 65 g/L/ <65 g/L], Lipase [>2.0 - 5.0*ULN], Lymphocytes (Lymph.)(Absolute [Abs]) [<0.5 - 0.2*10^3/microliter (UL)/ <0.2*10^3/UL], Platelets [<50-25*10^3/UL/ <25*10^3/UL], potassium (low) [<3.0 - 2.5 mmol/L], Sodium (low) [<130 - 120 mmol/L], Total Neutrophils (TN) (Abs) [<1.0 - 0.5*10^3/UL/ <0.5*10^3/UL], Triglycerides [>5.7 - 11.4 mmol/L], White Blood Cell Count (WBC) [<2.0 - 1.0*10^3/UL/ <1.0*10^3/UL].
Number of Participants Who Discontinued Due to Adverse Events
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants who discontinued due to adverse events were reported.
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 52 that were absent before treatment or that worsened relative to pretreatment state. Number of participants with treatment-emergent AEs or SAEs (excluding infectious AEs or SAEs and injection site reactions) were reported. AEs include both SAEs and non-SAEs.
Number of Participants With Treatment-Emergent Infectious Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 52 that were absent before treatment or that worsened relative to pretreatment state. Number of participants with treatment-emergent infectious AEs or SAEs were reported. AEs include both SAEs and non-SAEs.
Number of Participants With Potentially Clinically Important (PCI) Electrocardiogram (ECG) Findings
Criteria for potentially clinically important (PCI) findings in ECG were defined as: heart rate <=40 beats per minute (bpm) or >=120 bpm; PR interval >=220 millisecond (msec); QT interval >=480 msec; QRS interval >=120 msec; QT interval corrected using the Fridericia formula (QTcF) >=500msec; no sinus rhythm.
Number of Participants With Potentially Clinically Important Vital Signs Findings
Criteria for PCI findings in vital signs were defined as: sitting systolic blood pressure (Increase from baseline >=20 millimeter of mercury (mm Hg) and >=160 mm Hg or a decrease from baseline >=20 mm Hg and <=90 mm Hg) and sitting diastolic blood pressure (increase from baseline >=15 mm Hg and >=90 mm Hg or decrease from baseline >=15 mm Hg and <=60 mm Hg), pulse rate (increase from baseline >=15 beats/min and >=120 beats/min or decrease from baseline >=15 beats/min and <=50 beats /min), body temperature (increase of >=2 degree Fahrenheit (F) and temperature >=101 degree F) and weight (change of >=7% in body weight)
Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (Nabs)
Human serum samples were analyzed for the presence or absence of anti-PF-04236921 antibodies. A positive ADA sample was further tested for neutralizing antibodies using a validated assay.
Serum Concentration of PF-04236921
Serum PF-04236921 concentrations over time were summarized.
Percentage of Participants With Corticosteroid Dose Reduced by Both Greater Than or Equal to (>=) 25 Percent (%) From Baseline and Less Than or Equal to (<=) 7.5 Milligrams Per Day (mg/Day)
Participants were given supplemental corticosteroids at baseline to control disease activity, if necessary. The steroid taper was based on participant's symptoms. Participants recorded their steroid usage on a diary card. Least Observation Carried Forward (LOCF) method was used to impute missing data.
Percentage of Participants With Normalized Serological Activity
Serologic activity was to be assessed in the subgroup of participants who had positive serologic activity at baseline.
Patient Global Visual Analog Scale (VAS) Scores at Baseline
Participants assessed their disease activity using a 100 millimeter (mm) VAS. Participants answered the following question "Considering all the ways your disease affects you, how are you feeling today?" Response was recorded by placing a mark on the scale between 0 (very well) and 100 (extremely bad).
Change From Baseline in Patient Global Visual Analog Scale (VAS) at Week 2, 4, 6, 8, 12, 16, 20 and 24
Participants assessed their disease activity using a 100 mm VAS. Participants answered the following question "Considering all the ways your disease affects you, how are you feeling today?" Response was recorded by placing a mark on the scale between 0 (very well) and 100 (extremely bad).
Change From Baseline in European Quality of Life 5 Dimensions Questionnaire (EQ-5D) at Week 4, 8, 12, 16, 20 and 24
EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point VAS (0= worst imaginable health state, 100= best imaginable health state).
Thirty Six-Item Short-Form Health Survey (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Baseline
SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and mental component score MCS. The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) PCS and MCS at Week 4, 8, 12, 16, 20 and 24
SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.
Change From Baseline in Vitality Scores at Week 4, 8, 12, 16, 20 and 24
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Vitality sub-score is a component of SF-36 Health Survey Questionnaire and assesses energy and fatigue. The vitality score ranged from 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.
Change From Baseline in Short Form-6 Dimension (SF-6D) at Week 4, 8, 12, 16, 20 and 24
The SF-6D focuses on seven of the eight health domains covered by the SF-36 Health Survey: physical functioning, role participation (combined role-physical and role-emotional), social functioning, bodily pain, mental health, and vitality. The SF-6D is an attempt to derive a single index from the SF-36 Health Survey for use in economic evaluation studies. As such, it represents a summary score based on a subset of the SF-36 data. Consequently, in lieu of the SF-6D, PCS and MCS SF-36 results are being provided. The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Baseline
FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 4, 8, 12, 16, 20 and 24
FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). LOCF method was used to impute missing values.

Full Information

First Posted
July 27, 2011
Last Updated
December 18, 2017
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01405196
Brief Title
Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus
Acronym
BUTTERFLY
Official Title
A Double-blind, Randomized, Placebo-controlled, Multicenter Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Systemic Lupus Erythematosus (Sle)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
December 2011 (Actual)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (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
The objective of this study is to evaluate and compare efficacy of 3 dose levels of PF-04236921 to placebo in subjects with generalized lupus using a measure called the Systemic Lupus Erythematosus (SLE) Responder Index. The study will evaluate secondary and exploratory measures as well.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
Keywords
double-blind, placebo-controlled, multicenter, dose-ranging, efficacy, safety, lupus.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 mg of PF-04236921
Arm Type
Other
Arm Title
50 mg of PF-04236921
Arm Type
Other
Arm Title
200 mg of PF-04236921
Arm Type
Other
Arm Title
Placebo
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
PF-04236921
Intervention Description
subcutaneous injection; administered at day 1, weeks 8, 16.
Intervention Type
Biological
Intervention Name(s)
PF-04236921
Intervention Description
subcutaneous injection; administered at day 1, weeks 8, 16.
Intervention Type
Biological
Intervention Name(s)
PF-04236921
Intervention Description
subcutaneous injection; administered at day 1, weeks 8, 16.
Intervention Type
Biological
Intervention Name(s)
PF-04236921
Intervention Description
subcutaneous injection; administered at day 1, weeks 8, 16
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 24
Description
SRI components include:Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K),British Isles Lupus Assessment Group(BILAG) 2004,Physician's Global Assessment(PhGA).Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: greater than or equal to(>=) 4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (less than [<] 0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K:assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG:assesses disease extent, severity (range: A[severe] to E[no disease]). PhGA: assesses worsening in participant's general health status(range: 0[none] to 3[severe]).
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, and 20
Description
SRI components include:SLEDAI-2K ,BILAG 2004, PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: >=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG:assesses disease extent, severity (range: A [severe] to E [no disease]). PhGA: assesses worsening in participant's general health status(range: 0[none] to 3[severe]).
Time Frame
Week 4, 8, 12, 16, 20
Title
Percentage of Participants Achieving Modified Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, 20, and 24
Description
SRI components include: modified SLEDAI-2K (SLEDAI-2K without standard parameters "Low complement" and "Leukopenia"), BILAG 2004, PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: >=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids, immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. Modified SLEDAI-2K: assesses improvement in disease activity (range: 0 to 102; higher score = higher severity). BILAG: assesses disease extent, severity (range: A [severe] to E [no disease]). PhGA: assesses worsening in participant's general health status (range: 0[none] to 3[severe]).
Time Frame
Week 4, 8, 12, 16, 20, 24
Title
Percentage of Participants Achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response at Week 4, 8, 12, 16, 20, and 24
Description
BICLA include: BILAG-2004, SLEDAI-2K, PhGA of disease activity. Participants classified as responder if they did not meet the definition of treatment failure and met all the following criteria: BILAG-2004 improvement (all A scores at baseline improved to B/C/D and all B scores improved to C or D); no worsening in disease activity (no new BILAG-2004 A scores or =<1 new B score); no worsening of total SLEDAI-2K score; no significant deterioration (<10 percent [%] worsening) in analogue PhGA. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. BILAG:assesses disease extent, severity (range: A[severe] to E[no disease]). SLEDAI-2K:assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). PhGA: assesses worsening in participant's general health status(range: 0[none] to 3[severe]).
Time Frame
Week 4, 8, 12, 16, 20, 24
Title
Percentage of Participants Achieving Pre-defined Criteria for Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Components at Week 24
Description
SRI components include: SLEDAI-2K, BILAG 2004 and PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: >=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening(<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids, immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K: assesses improvement in disease activity(range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity (range: A[severe] to E [no disease]). PhGA: assesses worsening in participant's general health status (range: 0[none] to 3[severe]). Model percent estimates reported only for 'Reduction in SLEDAI Score','No Worsening in PhGA' categories; for remaining categories, raw percentages reported
Time Frame
Week 24
Title
Number of Participants With Clinically Significant Laboratory Tests Results
Description
Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. Laboratory values included Alanine Aminotransferase (ALT) [>5.0 - 10.0*Upper limit of normal range (ULN)], Albumin [<26-20 gram per liter (g/L)/ <20 g/L], Amylase [>2.0 - 5.0*ULN], Aspartate Aminotransferase (AST) [>5.0 - 10.0*ULN], Creatine Kinase (CK) [>5.0 - 10.0* ULN/ >10.0*ULN], Glucose (Hyperglycemia) [>13.9 - 27.8 millimoles/liter (mmol/L)], Hemoglobin (HGB) [<80 - 65 g/L/ <65 g/L], Lipase [>2.0 - 5.0*ULN], Lymphocytes (Lymph.)(Absolute [Abs]) [<0.5 - 0.2*10^3/microliter (UL)/ <0.2*10^3/UL], Platelets [<50-25*10^3/UL/ <25*10^3/UL], potassium (low) [<3.0 - 2.5 mmol/L], Sodium (low) [<130 - 120 mmol/L], Total Neutrophils (TN) (Abs) [<1.0 - 0.5*10^3/UL/ <0.5*10^3/UL], Triglycerides [>5.7 - 11.4 mmol/L], White Blood Cell Count (WBC) [<2.0 - 1.0*10^3/UL/ <1.0*10^3/UL].
Time Frame
Baseline up to Week 52
Title
Number of Participants Who Discontinued Due to Adverse Events
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants who discontinued due to adverse events were reported.
Time Frame
Baseline up to Week 52
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 52 that were absent before treatment or that worsened relative to pretreatment state. Number of participants with treatment-emergent AEs or SAEs (excluding infectious AEs or SAEs and injection site reactions) were reported. AEs include both SAEs and non-SAEs.
Time Frame
Baseline up to Week 52
Title
Number of Participants With Treatment-Emergent Infectious Adverse Events (AEs) or Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 52 that were absent before treatment or that worsened relative to pretreatment state. Number of participants with treatment-emergent infectious AEs or SAEs were reported. AEs include both SAEs and non-SAEs.
Time Frame
Baseline up to Week 52
Title
Number of Participants With Potentially Clinically Important (PCI) Electrocardiogram (ECG) Findings
Description
Criteria for potentially clinically important (PCI) findings in ECG were defined as: heart rate <=40 beats per minute (bpm) or >=120 bpm; PR interval >=220 millisecond (msec); QT interval >=480 msec; QRS interval >=120 msec; QT interval corrected using the Fridericia formula (QTcF) >=500msec; no sinus rhythm.
Time Frame
Baseline up to Week 52
Title
Number of Participants With Potentially Clinically Important Vital Signs Findings
Description
Criteria for PCI findings in vital signs were defined as: sitting systolic blood pressure (Increase from baseline >=20 millimeter of mercury (mm Hg) and >=160 mm Hg or a decrease from baseline >=20 mm Hg and <=90 mm Hg) and sitting diastolic blood pressure (increase from baseline >=15 mm Hg and >=90 mm Hg or decrease from baseline >=15 mm Hg and <=60 mm Hg), pulse rate (increase from baseline >=15 beats/min and >=120 beats/min or decrease from baseline >=15 beats/min and <=50 beats /min), body temperature (increase of >=2 degree Fahrenheit (F) and temperature >=101 degree F) and weight (change of >=7% in body weight)
Time Frame
Baseline up to Week 52
Title
Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (Nabs)
Description
Human serum samples were analyzed for the presence or absence of anti-PF-04236921 antibodies. A positive ADA sample was further tested for neutralizing antibodies using a validated assay.
Time Frame
Baseline up to Week 52
Title
Serum Concentration of PF-04236921
Description
Serum PF-04236921 concentrations over time were summarized.
Time Frame
Day 1, Week 2, 4, 6, 8, 12, 16, 20, 24
Title
Percentage of Participants With Corticosteroid Dose Reduced by Both Greater Than or Equal to (>=) 25 Percent (%) From Baseline and Less Than or Equal to (<=) 7.5 Milligrams Per Day (mg/Day)
Description
Participants were given supplemental corticosteroids at baseline to control disease activity, if necessary. The steroid taper was based on participant's symptoms. Participants recorded their steroid usage on a diary card. Least Observation Carried Forward (LOCF) method was used to impute missing data.
Time Frame
Week 12, 16, 20, 24
Title
Percentage of Participants With Normalized Serological Activity
Description
Serologic activity was to be assessed in the subgroup of participants who had positive serologic activity at baseline.
Time Frame
Baseline up to Week 24
Title
Patient Global Visual Analog Scale (VAS) Scores at Baseline
Description
Participants assessed their disease activity using a 100 millimeter (mm) VAS. Participants answered the following question "Considering all the ways your disease affects you, how are you feeling today?" Response was recorded by placing a mark on the scale between 0 (very well) and 100 (extremely bad).
Time Frame
Baseline
Title
Change From Baseline in Patient Global Visual Analog Scale (VAS) at Week 2, 4, 6, 8, 12, 16, 20 and 24
Description
Participants assessed their disease activity using a 100 mm VAS. Participants answered the following question "Considering all the ways your disease affects you, how are you feeling today?" Response was recorded by placing a mark on the scale between 0 (very well) and 100 (extremely bad).
Time Frame
Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24
Title
Change From Baseline in European Quality of Life 5 Dimensions Questionnaire (EQ-5D) at Week 4, 8, 12, 16, 20 and 24
Description
EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point VAS (0= worst imaginable health state, 100= best imaginable health state).
Time Frame
Baseline, Week 4, 8, 12, 16, 20, 24
Title
Thirty Six-Item Short-Form Health Survey (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Baseline
Description
SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and mental component score MCS. The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.
Time Frame
Baseline
Title
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) PCS and MCS at Week 4, 8, 12, 16, 20 and 24
Description
SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.
Time Frame
Baseline, Week 4, 8, 12, 16, 20, 24
Title
Change From Baseline in Vitality Scores at Week 4, 8, 12, 16, 20 and 24
Description
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Vitality sub-score is a component of SF-36 Health Survey Questionnaire and assesses energy and fatigue. The vitality score ranged from 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.
Time Frame
Baseline, Week 4, 8, 12, 16, 20, 24
Title
Change From Baseline in Short Form-6 Dimension (SF-6D) at Week 4, 8, 12, 16, 20 and 24
Description
The SF-6D focuses on seven of the eight health domains covered by the SF-36 Health Survey: physical functioning, role participation (combined role-physical and role-emotional), social functioning, bodily pain, mental health, and vitality. The SF-6D is an attempt to derive a single index from the SF-36 Health Survey for use in economic evaluation studies. As such, it represents a summary score based on a subset of the SF-36 data. Consequently, in lieu of the SF-6D, PCS and MCS SF-36 results are being provided. The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.
Time Frame
Baseline, Week 4, 8, 12, 16, 20, 24
Title
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Baseline
Description
FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).
Time Frame
Baseline
Title
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 4, 8, 12, 16, 20 and 24
Description
FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). LOCF method was used to impute missing values.
Time Frame
Baseline, Week 4, 8, 12, 16, 20, 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects between ages of 18 and 75 years old at time of signing consent. Have a clinical diagnosis of SLE according to 1997 update on the revised 1982 American College of Rheumatology (ACR) criteria. Have a unequivocally positive anti-nuclear antibody (ANA) test result. Active disease at screening defined by both: SLEDAI-2K score greater than or equal to 6 and BILAG Level A disease in more than or equal to 1 organ system (except renal or central nervous system) or BILAG B disease in more than or equal to 2 organ systems if no level A disease in present. Exclusion Criteria: Any prior history of treatment with PF-04236921, or anti-IL-6 agent; Have received any of the following within 364 days of day 1: a biologic investigational agent other than B cell targeted therapy; required 3 or more courses of systemic corticosteroids for concomitant conditions; history of previously untreated or current evidence of active or untreated latent infection with Tuberculosis (TB), evidence of prior untreated or currently active TB by chest radiography, residing with or frequent close contact with an individual with active TB.
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
Anniston Medical Clinic, PC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Achieve Clinical Research, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Med Investigations, Inc.
City
Fair Oaks
State/Province
California
ZIP/Postal Code
95628
Country
United States
Facility Name
Premier Clinical Research, LLC
City
Lakewood
State/Province
California
ZIP/Postal Code
90712
Country
United States
Facility Name
Novo Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
St Mary Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Wallace Rheumatic Study Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UCLA Division of Rheumatology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1670
Country
United States
Facility Name
UCLA Rheumatology Clinical Research Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1670
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-6984
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Inland Rheumatology and Osteoporosis Medical Group
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Inland Rheumatology Clinical Trials, Inc.
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Asthma, Allergy, Arthritis and Lung Center
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Southeastern Arthritis Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Southeastern Community Pharmacy
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Southeastern Integrated Medical, PL, d/b/a Florida Medical Research Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Southeastern lmaging & Diagnostics
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Arthritis Associates
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Millennium Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
The Arthritis Center
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Advent Clinical Research Centers, Inc.
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Burnette & Silverfield, MDS PLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Grady Health Systems
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Idaho Arthritis Center
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Beacon Medical Group Rheumatology
City
Granger
State/Province
Indiana
ZIP/Postal Code
46530
Country
United States
Facility Name
Indiana CTSI Clinical Research Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Investigational Drug Services
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Johns Hopkins Outpatient Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Johns Hopkins Outpatient Express Testing Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Tufts Medical Center/ Center for Arthritis and Rheumatic Diseases
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5008
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5422
Country
United States
Facility Name
University of Michigan Health System,
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5872
Country
United States
Facility Name
Henry Ford Health System (Henry Ford Medical Center)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-3450
Country
United States
Facility Name
Shores Rheumatology P.C
City
Saint Clair Shores
State/Province
Michigan
ZIP/Postal Code
48081
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
Albuquerque Clinical Trials
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Arthritis and Osteoporosis Medical Associates, PLLC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Feinstein Institute for Medical Research
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
NYU Center for Musculoskeletal Care
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Allergy/Immunology and Rheumatology
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
The University of North Carolina Clinical and Translational Research Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
The University of North Carolina Hospitals Investigational Drug Services
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Joint and Muscle Medical Care
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Box Arthritis & Rheumatology of the Carolinas, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Paramount Medical Research and Consulting, LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Oklahoma Medical Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Clinical Research Center of Reading, LLP
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Low Country Rheumatology, PA/Low Country Research
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
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
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8577
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Rheumatic Disease Clinical Research Center, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Accurate Clinical Research, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Southwest Rheumatology Research, LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
The Seattle Arthritis Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
Tacoma Center for Arthritis Research, PS
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Mountain State Clinical Research
City
Clarksburg
State/Province
West Virginia
ZIP/Postal Code
26301
Country
United States
Facility Name
Framingham Centro Medico
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B1902COS
Country
Argentina
Facility Name
Instituto CAICI S.R.L.
City
Rosario
State/Province
Santa FE
ZIP/Postal Code
S2000PBJ
Country
Argentina
Facility Name
Centro Medico Privado de Reumatologia
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Centro de Educación Medica e Investigaciones Clinicas "Norberto Quirno" CEMIC
City
C.a.b.a
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
Centro Polivalente de Asistencia e Investigación Clínica - CER- San Juan
City
San Juan
ZIP/Postal Code
J5402DIL
Country
Argentina
Facility Name
Sociedad Medica del Aparato Locomotor S.A. (SOMEAL)
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
7510186
Country
Chile
Facility Name
Centro de Estudios Reumatologicos
City
Santiago
State/Province
RM
ZIP/Postal Code
7501126
Country
Chile
Facility Name
Centro Medico Prosalud
City
Santiago
State/Province
RM
Country
Chile
Facility Name
Mix Supplier S.A.
City
Envigado
State/Province
Antioquia, Colombia
Country
Colombia
Facility Name
Centro Integral de Reumatologia REUMALAB S.A.S.
City
Envigado
State/Province
Antioquia
Country
Colombia
Facility Name
Hospital Pablo Tobon Uribe
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
0
Country
Colombia
Facility Name
Centro Integral de Reumatología del Caribe CIRCARIBE SAS
City
Barranquilla
State/Province
Atlantico
Country
Colombia
Facility Name
Congregacion de Hermanas Franciscanas Misioneras de Maria Auxiliadora- Clinica Asunción
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
Farmamix Ltda.
City
Bogota, Distrito Capital
State/Province
Cundimarca
Country
Colombia
Facility Name
Centro Integral de Reumatologia e Inmunologia S.A.S.- CIREI S.A.S.
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Riesgo De Fractura S.A
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Servimed E.U
City
Bucaramanga
State/Province
Santander
Country
Colombia
Facility Name
Farmamix Ltda.
City
Bogota
Country
Colombia
Facility Name
Charité - Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charité University Medicine Berlin. Schlosspark-Klinik
City
Berlin
ZIP/Postal Code
14059
Country
Germany
Facility Name
Universitaetsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
CIRI am Klinikum der Goethe-Universitaet
City
Frankfurt/Main
ZIP/Postal Code
60528
Country
Germany
Facility Name
Universitaetsklinikum Koeln
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitaetsklinikum Leipzig AoeR, Department fuer Innere Medizin
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Qualiclinic Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum
City
Debrecen
ZIP/Postal Code
H-4032
Country
Hungary
Facility Name
Bekes Megyei Kepviselo-testulet Pandy Kalman Korhaz Infektologia, Hepatologia es Immunologia
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Dong-A University Medical Center 1
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Spitalul Clinic Republican
City
Chisinau
State/Province
Md-2025
ZIP/Postal Code
2025
Country
Moldova, Republic of
Facility Name
Centro de Investigacion REUMED, Clinica Anglo Americana
City
San Isidro
State/Province
Lima
ZIP/Postal Code
Lima 27
Country
Peru
Facility Name
Investigaciones Clínicas SAC
City
Santiago de Surco
State/Province
Lima
ZIP/Postal Code
Lima 33
Country
Peru
Facility Name
Investigaciones Clinicas SAC
City
Surco
State/Province
Lima
ZIP/Postal Code
Lima 33
Country
Peru
Facility Name
Unidad de Investigación en Medicina Interna y Enfermedades Críticas
City
Arequipa
ZIP/Postal Code
AQ 54
Country
Peru
Facility Name
NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska lek.med. Barbara Bazela
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Medyczne Centrum Hetmanska - Indywidualna Specjalistyczna Praktyka Lekarska -
City
Poznan
ZIP/Postal Code
60-218
Country
Poland
Facility Name
Prywatna Praktyka Lekarska Prof. UM Dr hab. med. Pawel Hrycaj
City
Poznan
ZIP/Postal Code
61-397
Country
Poland
Facility Name
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
University of Puerto Rico
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Division of Rheumatology, Allergy and Immunology
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Spitalul Clinic Sf. Maria
City
Bucuresti
ZIP/Postal Code
11172
Country
Romania
Facility Name
Spitalul Clinic Colentina
City
Bucuresti
ZIP/Postal Code
20125
Country
Romania
Facility Name
Spitalul Clinic Jedetean de urgenta Cluj, Reumatologie
City
Cluj Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei"
City
Galati
ZIP/Postal Code
800578
Country
Romania
Facility Name
National Taiwan University Hospital
City
Taipei TOC
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
29776017
Citation
Li C, Shoji S, Beebe J. Pharmacokinetics and C-reactive protein modelling of anti-interleukin-6 antibody (PF-04236921) in healthy volunteers and patients with autoimmune disease. Br J Clin Pharmacol. 2018 Sep;84(9):2059-2074. doi: 10.1111/bcp.13641. Epub 2018 Jun 25.
Results Reference
derived
PubMed Identifier
27672124
Citation
Wallace DJ, Strand V, Merrill JT, Popa S, Spindler AJ, Eimon A, Petri M, Smolen JS, Wajdula J, Christensen J, Li C, Diehl A, Vincent MS, Beebe J, Healey P, Sridharan S. Efficacy and safety of an interleukin 6 monoclonal antibody for the treatment of systemic lupus erythematosus: a phase II dose-ranging randomised controlled trial. Ann Rheum Dis. 2017 Mar;76(3):534-542. doi: 10.1136/annrheumdis-2016-209668. Epub 2016 Sep 26.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0151006&StudyName=Subcutaneous%20Treatment%20In%20Randomized%20Subjects%20To%20Evaluate%20Safety%20And%20Efficacy%20In%20Generalized%20Lupus%20Erythematosus%0A%20%20
Description
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Learn more about this trial

Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus

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