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

December 18, 2017 updated by: Pfizer

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
183

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • C.a.b.a, Argentina, C1431FWO
        • Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" Cemic
      • San Juan, Argentina, J5402DIL
        • Centro Polivalente de Asistencia e Investigación Clínica - CER- San Juan
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, B1902COS
        • Framingham Centro Medico
    • Santa FE
      • Rosario, Santa FE, Argentina, S2000PBJ
        • Instituto CAICI S.R.L.
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, T4000AXL
        • Centro Medico Privado de Reumatologia
  • Chile
    • RM
      • Santiago, RM, Chile, 7501126
        • Centro de Estudios Reumatologicos
      • Santiago, RM, Chile
        • Centro Medico Prosalud
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile, 7510186
        • Sociedad Medica del Aparato Locomotor S.A. (SOMEAL)
  • Colombia
      • Bogota, Colombia
        • Farmamix Ltda.
    • Antioquia
      • Envigado, Antioquia, Colombia
        • Centro Integral de Reumatologia REUMALAB S.A.S.
      • Medellin, Antioquia, Colombia
        • Hospital Pablo Tobón Uribe
    • Antioquia, Colombia
      • Envigado, Antioquia, Colombia, Colombia
        • Mix Supplier S.A.
    • Atlantico
      • Barranquilla, Atlantico, Colombia
        • Organizacion Clinica General del Norte S.A.
      • Barranquilla, Atlantico, Colombia
        • Centro Integral de Reumatología del Caribe Circaribe SAS
      • Barranquilla, Atlantico, Colombia
        • Congregacion de Hermanas Franciscanas Misioneras de Maria Auxiliadora- Clinica Asunción
    • Cundimarca
      • Bogota, Distrito Capital, Cundimarca, Colombia
        • Farmamix Ltda.
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Riesgo De Fractura S.A
      • Bogota, Cundinamarca, Colombia
        • Centro Integral de Reumatologia e Inmunologia S.A.S.- CIREI S.A.S.
    • Santander
      • Bucaramanga, Santander, Colombia
        • Servimed E.U
  • Germany
      • Berlin, Germany, 10117
        • Charite - Universitaetsmedizin Berlin
      • Berlin, Germany, 14059
        • Charité University Medicine Berlin. Schlosspark-Klinik
      • Erlangen, Germany, 91054
        • Universitaetsklinikum Erlangen
      • Frankfurt/Main, Germany, 60528
        • CIRI am Klinikum der Goethe-Universitaet
      • Koeln, Germany, 50937
        • Universitaetsklinikum Koeln
      • Leipzig, Germany, 04103
        • Universitaetsklinikum Leipzig AoeR, Department fuer Innere Medizin
  • Hungary
      • Budapest, Hungary, 1036
        • Qualiclinic Kft.
      • Debrecen, Hungary, H-4032
        • Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum
      • Gyula, Hungary, 5700
        • Bekes Megyei Kepviselo-testulet Pandy Kalman Korhaz Infektologia, Hepatologia es Immunologia
  • Korea, Republic of
      • Busan, Korea, Republic of, 602-715
        • Dong-A University Medical Center 1
  • Moldova, Republic of
    • Md-2025
      • Chisinau, Md-2025, Moldova, Republic of, 2025
        • Spitalul Clinic Republican
  • Peru
      • Arequipa, Peru, AQ 54
        • Unidad de Investigación en Medicina Interna y Enfermedades Críticas
    • Lima
      • San Isidro, Lima, Peru, Lima 27
        • Centro de Investigacion REUMED, Clinica Anglo Americana
      • Santiago de Surco, Lima, Peru, Lima 33
        • Investigaciones Clinicas SAC
      • Surco, Lima, Peru, Lima 33
        • Investigaciones Clinicas SAC
  • Poland
      • Elblag, Poland, 82-300
        • NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska lek.med. Barbara Bazela
      • Poznan, Poland, 61-397
        • Prywatna Praktyka Lekarska Prof. UM dr Hab. Med. Pawel Hrycaj
      • Poznan, Poland, 60-218
        • Medyczne Centrum Hetmanska - Indywidualna Specjalistyczna Praktyka Lekarska -
      • Warszawa, Poland, 02-507
        • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
        • University of Puerto Rico
      • San Juan, Puerto Rico, 00935
        • Division of Rheumatology, Allergy and Immunology
  • Romania
      • Bucuresti, Romania, 20125
        • Spitalul Clinic Colentina
      • Bucuresti, Romania, 11172
        • Spitalul Clinic Sf. Maria
      • Cluj Napoca, Romania, 400006
        • Spitalul Clinic Jedetean de urgenta Cluj, Reumatologie
      • Galati, Romania, 800578
        • Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei"
  • Taiwan
      • Taipei TOC, Taiwan, 100
        • National Taiwan University Hospital
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group, LLC
      • Anniston, Alabama, United States, 36207
        • Anniston Medical Clinic, PC
      • Birmingham, Alabama, United States, 35216
        • Achieve Clinical Research, LLC
    • California
      • Fair Oaks, California, United States, 95628
        • Med Investigations, Inc.
      • Lakewood, California, United States, 90712
        • Premier Clinical Research, LLC
      • Long Beach, California, United States, 90813
        • Novo Research
      • Long Beach, California, United States, 90813
        • St Mary Medical Center
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
      • Los Angeles, California, United States, 90048
        • Wallace Rheumatic Study Center
      • Los Angeles, California, United States, 90095-6984
        • Ronald Reagan UCLA Medical Center
      • Los Angeles, California, United States, 90095-1670
        • UCLA Division of Rheumatology
      • Los Angeles, California, United States, 90095-1670
        • UCLA Rheumatology Clinical Research Center
      • Upland, California, United States, 91786
        • Inland Rheumatology Clinical Trials, Inc.
      • Upland, California, United States, 91786
        • Inland Rheumatology and Osteoporosis Medical Group
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Asthma, Allergy, Arthritis and Lung Center
      • Gainesville, Florida, United States, 32607
        • Southeastern Arthritis Center
      • Gainesville, Florida, United States, 32607
        • Southeastern Integrated Medical, PL, d/b/a Florida Medical Research Institute
      • Gainesville, Florida, United States, 32607
        • Southeastern Community Pharmacy
      • Gainesville, Florida, United States, 32607
        • Southeastern lmaging & Diagnostics
      • Miami, Florida, United States, 33175
        • New Horizon Research Center
      • Orlando, Florida, United States, 32804
        • Arthritis Associates
      • Ormond Beach, Florida, United States, 32174
        • Millennium Research
      • Palm Harbor, Florida, United States, 34684
        • The Arthritis Center
      • Pinellas Park, Florida, United States, 33781
        • Advent Clinical Research Centers, Inc.
      • Tampa, Florida, United States, 33614
        • Burnette & Silverfield, MDS PLC
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Emory University
      • Atlanta, Georgia, United States, 30303
        • Grady Health Systems
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Idaho Arthritis Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
    • Indiana
      • Granger, Indiana, United States, 46530
        • Beacon Medical Group Rheumatology
      • Indianapolis, Indiana, United States, 46202
        • Indiana CTSI Clinical Research Center
      • Indianapolis, Indiana, United States, 46202
        • Investigational Drug Services
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University School of Medicine
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Outpatient Center
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Outpatient Express Testing Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center/ Center for Arthritis and Rheumatic Diseases
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5422
        • University of Michigan Health System
      • Ann Arbor, Michigan, United States, 48109-5008
        • University of Michigan
      • Ann Arbor, Michigan, United States, 48109-5872
        • University of Michigan Health System,
      • Detroit, Michigan, United States, 48201-3450
        • Henry Ford Health System (Henry Ford Medical Center)
      • Saint Clair Shores, Michigan, United States, 48081
        • Shores Rheumatology P.C
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • University of Nevada School of Medicine
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials
    • New York
      • Brooklyn, New York, United States, 11201
        • Arthritis and Osteoporosis Medical Associates, PLLC
      • Manhasset, New York, United States, 11030
        • Feinstein Institute for Medical Research
      • New York, New York, United States, 10016
        • NYU Center for Musculoskeletal Care
      • Rochester, New York, United States, 14623
        • Allergy/Immunology and Rheumatology
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • The University of North Carolina at Chapel Hill
      • Chapel Hill, North Carolina, United States, 27514
        • The University of North Carolina Clinical and Translational Research Center
      • Chapel Hill, North Carolina, United States, 27514
        • The University of North Carolina Hospitals Investigational Drug Services
      • Charlotte, North Carolina, United States, 28210
        • Box Arthritis & Rheumatology of the Carolinas, PLLC
      • Charlotte, North Carolina, United States, 28204
        • Joint and Muscle Medical Care
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Middleburg Heights, Ohio, United States, 44130
        • Paramount Medical Research and Consulting, Llc
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Medical Research Foundation
    • Pennsylvania
      • Wyomissing, Pennsylvania, United States, 19610
        • Clinical Research Center of Reading, LLP
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Low Country Rheumatology, PA/Low Country Research
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Arthritis Clinic
      • Jackson, Tennessee, United States, 38305
        • West Tennessee Research Institute
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • Dallas, Texas, United States, 75390-8577
        • UT Southwestern Medical Center
      • Houston, Texas, United States, 77034
        • Accurate Clinical Research, Inc.
      • Houston, Texas, United States, 77004
        • Rheumatic Disease Clinical Research Center, LLC
      • Mesquite, Texas, United States, 75150
        • SouthWest Rheumatology Research, LLC
    • Washington
      • Seattle, Washington, United States, 98133
        • The Seattle Arthritis Clinic
      • Tacoma, Washington, United States, 98405
        • Tacoma Center for Arthritis Research, PS
    • West Virginia
      • Clarksburg, West Virginia, United States, 26301
        • Mountain State Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Placebo
Biological: PF-04236921
subcutaneous injection; administered at day 1, weeks 8, 16.
Biological: PF-04236921
subcutaneous injection; administered at day 1, weeks 8, 16
Other: 10 mg of PF-04236921
Biological: PF-04236921
subcutaneous injection; administered at day 1, weeks 8, 16.
Biological: PF-04236921
subcutaneous injection; administered at day 1, weeks 8, 16
Other: 50 mg of PF-04236921
Biological: PF-04236921
subcutaneous injection; administered at day 1, weeks 8, 16.
Biological: PF-04236921
subcutaneous injection; administered at day 1, weeks 8, 16
Other: 200 mg of PF-04236921
Biological: PF-04236921
subcutaneous injection; administered at day 1, weeks 8, 16.
Biological: PF-04236921
subcutaneous injection; administered at day 1, weeks 8, 16

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 24
Time Frame: 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]).
Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, and 20
Time Frame: Week 4, 8, 12, 16, 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]).
Week 4, 8, 12, 16, 20
Percentage of Participants Achieving Modified Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, 20, and 24
Time Frame: Week 4, 8, 12, 16, 20, 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]).
Week 4, 8, 12, 16, 20, 24
Percentage of Participants Achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response at Week 4, 8, 12, 16, 20, and 24
Time Frame: Week 4, 8, 12, 16, 20, 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]).
Week 4, 8, 12, 16, 20, 24
Percentage of Participants Achieving Pre-defined Criteria for Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Components at Week 24
Time Frame: 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
Week 24
Number of Participants With Clinically Significant Laboratory Tests Results
Time Frame: Baseline up to Week 52
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].
Baseline up to Week 52
Number of Participants Who Discontinued Due to Adverse Events
Time Frame: Baseline up to Week 52
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.
Baseline up to Week 52
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time Frame: Baseline up to Week 52
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.
Baseline up to Week 52
Number of Participants With Treatment-Emergent Infectious Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time Frame: Baseline up to Week 52
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.
Baseline up to Week 52
Number of Participants With Potentially Clinically Important (PCI) Electrocardiogram (ECG) Findings
Time Frame: Baseline up to Week 52
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.
Baseline up to Week 52
Number of Participants With Potentially Clinically Important Vital Signs Findings
Time Frame: Baseline up to Week 52
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)
Baseline up to Week 52
Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (Nabs)
Time Frame: Baseline up to Week 52
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.
Baseline up to Week 52
Serum Concentration of PF-04236921
Time Frame: Day 1, Week 2, 4, 6, 8, 12, 16, 20, 24
Serum PF-04236921 concentrations over time were summarized.
Day 1, Week 2, 4, 6, 8, 12, 16, 20, 24
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)
Time Frame: Week 12, 16, 20, 24
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.
Week 12, 16, 20, 24
Percentage of Participants With Normalized Serological Activity
Time Frame: Baseline up to Week 24
Serologic activity was to be assessed in the subgroup of participants who had positive serologic activity at baseline.
Baseline up to Week 24
Patient Global Visual Analog Scale (VAS) Scores at Baseline
Time Frame: 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).
Baseline
Change From Baseline in Patient Global Visual Analog Scale (VAS) at Week 2, 4, 6, 8, 12, 16, 20 and 24
Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 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).
Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24
Change From Baseline in European Quality of Life 5 Dimensions Questionnaire (EQ-5D) at Week 4, 8, 12, 16, 20 and 24
Time Frame: Baseline, Week 4, 8, 12, 16, 20, 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).
Baseline, Week 4, 8, 12, 16, 20, 24
Thirty Six-Item Short-Form Health Survey (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Baseline
Time Frame: 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.
Baseline
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) PCS and MCS at Week 4, 8, 12, 16, 20 and 24
Time Frame: Baseline, Week 4, 8, 12, 16, 20, 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.
Baseline, Week 4, 8, 12, 16, 20, 24
Change From Baseline in Vitality Scores at Week 4, 8, 12, 16, 20 and 24
Time Frame: Baseline, Week 4, 8, 12, 16, 20, 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.
Baseline, Week 4, 8, 12, 16, 20, 24
Change From Baseline in Short Form-6 Dimension (SF-6D) at Week 4, 8, 12, 16, 20 and 24
Time Frame: Baseline, Week 4, 8, 12, 16, 20, 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.
Baseline, Week 4, 8, 12, 16, 20, 24
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Baseline
Time Frame: 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).
Baseline
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 4, 8, 12, 16, 20 and 24
Time Frame: Baseline, Week 4, 8, 12, 16, 20, 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.
Baseline, Week 4, 8, 12, 16, 20, 24

Collaborators and Investigators

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Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

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General Publications

Helpful Links

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

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Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B0151006
  • 2011-000420-15 (EudraCT Number)
  • Butterfly (Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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