Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus
BUTTERFLY
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)
3 other identifiers
interventional
183
13 countries
113
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2011
113 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2011
CompletedFirst Posted
Study publicly available on registry
July 29, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedResults Posted
Study results publicly available
December 19, 2017
CompletedDecember 19, 2017
December 1, 2017
2.2 years
July 27, 2011
November 18, 2016
December 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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\[severe\]).
Week 24
Secondary Outcomes (23)
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, and 20
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
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
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
Week 24
Number of Participants With Clinically Significant Laboratory Tests Results
Baseline up to Week 52
- +18 more secondary outcomes
Study Arms (4)
10 mg of PF-04236921
OTHER50 mg of PF-04236921
OTHER200 mg of PF-04236921
OTHERPlacebo
OTHERInterventions
subcutaneous injection; administered at day 1, weeks 8, 16.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (113)
Anniston Medical Clinic, PC
Anniston, Alabama, 36207, United States
Pinnacle Research Group, LLC
Anniston, Alabama, 36207, United States
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216, United States
Med Investigations, Inc.
Fair Oaks, California, 95628, United States
Premier Clinical Research, LLC
Lakewood, California, 90712, United States
Novo Research
Long Beach, California, 90813, United States
St Mary Medical Center
Long Beach, California, 90813, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Wallace Rheumatic Study Center
Los Angeles, California, 90048, United States
UCLA Division of Rheumatology
Los Angeles, California, 90095-1670, United States
UCLA Rheumatology Clinical Research Center
Los Angeles, California, 90095-1670, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095-6984, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
Inland Rheumatology and Osteoporosis Medical Group
Upland, California, 91786, United States
Inland Rheumatology Clinical Trials, Inc.
Upland, California, 91786, United States
Asthma, Allergy, Arthritis and Lung Center
Daytona Beach, Florida, 32114, United States
Southeastern Arthritis Center
Gainesville, Florida, 32607, United States
Southeastern Community Pharmacy
Gainesville, Florida, 32607, United States
Southeastern Integrated Medical, PL, d/b/a Florida Medical Research Institute
Gainesville, Florida, 32607, United States
Southeastern lmaging & Diagnostics
Gainesville, Florida, 32607, United States
New Horizon Research Center
Miami, Florida, 33175, United States
Arthritis Associates
Orlando, Florida, 32804, United States
Millennium Research
Ormond Beach, Florida, 32174, United States
The Arthritis Center
Palm Harbor, Florida, 34684, United States
Advent Clinical Research Centers, Inc.
Pinellas Park, Florida, 33781, United States
Burnette & Silverfield, MDS PLC
Tampa, Florida, 33614, United States
Emory University
Atlanta, Georgia, 30303, United States
Grady Health Systems
Atlanta, Georgia, 30303, United States
Idaho Arthritis Center
Meridian, Idaho, 83642, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Beacon Medical Group Rheumatology
Granger, Indiana, 46530, United States
Indiana CTSI Clinical Research Center
Indianapolis, Indiana, 46202, United States
Investigational Drug Services
Indianapolis, Indiana, 46202, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205, United States
Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287, United States
Johns Hopkins Outpatient Express Testing Center
Baltimore, Maryland, 21287, United States
Tufts Medical Center/ Center for Arthritis and Rheumatic Diseases
Boston, Massachusetts, 02111, United States
University of Michigan
Ann Arbor, Michigan, 48109-5008, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109-5422, United States
University of Michigan Health System,
Ann Arbor, Michigan, 48109-5872, United States
Henry Ford Health System (Henry Ford Medical Center)
Detroit, Michigan, 48201-3450, United States
Shores Rheumatology P.C
Saint Clair Shores, Michigan, 48081, United States
University of Nevada School of Medicine
Las Vegas, Nevada, 89102, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102, United States
Arthritis and Osteoporosis Medical Associates, PLLC
Brooklyn, New York, 11201, United States
Feinstein Institute for Medical Research
Manhasset, New York, 11030, United States
NYU Center for Musculoskeletal Care
New York, New York, 10016, United States
Allergy/Immunology and Rheumatology
Rochester, New York, 14623, United States
The University of North Carolina Clinical and Translational Research Center
Chapel Hill, North Carolina, 27514, United States
The University of North Carolina Hospitals Investigational Drug Services
Chapel Hill, North Carolina, 27514, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Joint and Muscle Medical Care
Charlotte, North Carolina, 28204, United States
Box Arthritis & Rheumatology of the Carolinas, PLLC
Charlotte, North Carolina, 28210, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Paramount Medical Research and Consulting, LLC
Middleburg Heights, Ohio, 44130, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104, United States
Clinical Research Center of Reading, LLP
Wyomissing, Pennsylvania, 19610, United States
Low Country Rheumatology, PA/Low Country Research
Charleston, South Carolina, 29406, United States
Arthritis Clinic
Jackson, Tennessee, 38305, United States
West Tennessee Research Institute
Jackson, Tennessee, 38305, United States
UT Southwestern Medical Center
Dallas, Texas, 75390-8577, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Rheumatic Disease Clinical Research Center, LLC
Houston, Texas, 77004, United States
Accurate Clinical Research, Inc.
Houston, Texas, 77034, United States
Southwest Rheumatology Research, LLC
Mesquite, Texas, 75150, United States
The Seattle Arthritis Clinic
Seattle, Washington, 98133, United States
Tacoma Center for Arthritis Research, PS
Tacoma, Washington, 98405, United States
Mountain State Clinical Research
Clarksburg, West Virginia, 26301, United States
Framingham Centro Medico
La Plata, Buenos Aires, B1902COS, Argentina
Instituto CAICI S.R.L.
Rosario, Santa Fe Province, S2000PBJ, Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina
Centro de Educación Medica e Investigaciones Clinicas "Norberto Quirno" CEMIC
C.a.b.a, C1431FWO, Argentina
Centro Polivalente de Asistencia e Investigación Clínica - CER- San Juan
San Juan, J5402DIL, Argentina
Centro de Estudios Reumatologicos
Santiago, RM, 7501126, Chile
Centro Medico Prosalud
Santiago, RM, Chile
Sociedad Medica del Aparato Locomotor S.A. (SOMEAL)
Santiago, Santiago Metropolitan, 7510186, Chile
Centro Integral de Reumatologia REUMALAB S.A.S.
Envigado, Antioquia, Colombia
Hospital Pablo Tobon Uribe
Medellín, Antioquia, 0, Colombia
Mix Supplier S.A.
Envigado, Antioquia, Colombia, Colombia
Centro Integral de Reumatología del Caribe CIRCARIBE SAS
Barranquilla, Atlántico, Colombia
Congregacion de Hermanas Franciscanas Misioneras de Maria Auxiliadora- Clinica Asunción
Barranquilla, Atlántico, Colombia
Organizacion Clinica General del Norte S.A.
Barranquilla, Atlántico, Colombia
Farmamix Ltda.
Bogota, Distrito Capital, Cundimarca, Colombia
Centro Integral de Reumatologia e Inmunologia S.A.S.- CIREI S.A.S.
Bogota, Cundinamarca, Colombia
Riesgo De Fractura S.A
Bogota, Cundinamarca, Colombia
Servimed E.U
Bucaramanga, Santander Department, Colombia
Farmamix Ltda.
Bogotá, Colombia
Charité - Universitaetsmedizin Berlin
Berlin, 10117, Germany
Charité University Medicine Berlin. Schlosspark-Klinik
Berlin, 14059, Germany
Universitaetsklinikum Koeln
Cologne, 50937, Germany
Universitaetsklinikum Erlangen
Erlangen, 91054, Germany
CIRI am Klinikum der Goethe-Universitaet
Frankfurt am Main, 60528, Germany
Universitaetsklinikum Leipzig AoeR, Department fuer Innere Medizin
Leipzig, 04103, Germany
Qualiclinic Kft.
Budapest, 1036, Hungary
Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum
Debrecen, H-4032, Hungary
Bekes Megyei Kepviselo-testulet Pandy Kalman Korhaz Infektologia, Hepatologia es Immunologia
Gyula, 5700, Hungary
Spitalul Clinic Republican
Chisinau, Md-2025, 2025, Moldova
Centro de Investigacion REUMED, Clinica Anglo Americana
San Isidro, Lima region, Lima 27, Peru
Investigaciones Clínicas SAC
Santiago de Surco, Lima region, Lima 33, Peru
Investigaciones Clinicas SAC
Surco, Lima region, Lima 33, Peru
Unidad de Investigación en Medicina Interna y Enfermedades Críticas
Arequipa, AQ 54, Peru
NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska lek.med. Barbara Bazela
Elblag, 82-300, Poland
Medyczne Centrum Hetmanska - Indywidualna Specjalistyczna Praktyka Lekarska -
Poznan, 60-218, Poland
Prywatna Praktyka Lekarska Prof. UM Dr hab. med. Pawel Hrycaj
Poznan, 61-397, Poland
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych
Warsaw, 02-507, Poland
University of Puerto Rico
Rio Piedras, 00935, Puerto Rico
Division of Rheumatology, Allergy and Immunology
San Juan, 00935, Puerto Rico
Spitalul Clinic Sf. Maria
Bucharest, 11172, Romania
Spitalul Clinic Colentina
Bucharest, 20125, Romania
Spitalul Clinic Jedetean de urgenta Cluj, Reumatologie
Cluj-Napoca, 400006, Romania
Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei"
Galati, 800578, Romania
Dong-A University Medical Center 1
Busan, 602-715, South Korea
National Taiwan University Hospital
Taipei TOC, 100, Taiwan
Related Publications (2)
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.
PMID: 29776017DERIVEDWallace 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.
PMID: 27672124DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2011
First Posted
July 29, 2011
Study Start
December 1, 2011
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
December 19, 2017
Results First Posted
December 19, 2017
Record last verified: 2017-12