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A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

Primary Purpose

Systemic Lupus Erythematosus

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
PF-06700841 15 mg
PF-06700841 30 mg
PF-06700841 45 mg
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

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

Inclusion Criteria:

  • Male and/or female subjects between ≥18 and ≤75 years of age inclusive.
  • Diagnosis of moderate to severe active Lupus.
  • Receiving a stable dose of methotrexate, azathioprine, leflunomide, mizoribine, mycophenolate/mycophenolic acid, anti-malarials or corticosteroids.

Exclusion Criteria:

  • Active renal lupus
  • Severe active central nervous system (CNS) lupus
  • Have cancer or a history of cancer within 5 years of screening.
  • Have a history of thrombosis (venous or arterial) or other vascular complications within the last 6 months, or any history of either recurrent thrombosis or a pulmonary embolus.
  • Active bacterial, viral, fungal, mycobacterial or other infections
  • Psychiatric condition including recent or active suicidal ideation or behavior
  • Have active fibromyalgia/myofascial/chronic pain.
  • Pregnant female subjects; breastfeeding female subjects; females subjects planning to become pregnant during the study; fertile male subjects and WOCBP who are unwilling or unable to use a highly effective method of contraception.

Sites / Locations

  • UAB Hospital Department of Pharmacy
  • UAB Hospital-Clinical Research Unit (CRU)
  • The University of Alabama at Birmingham
  • UAB Department of Medicine Clinical Research Enterprise
  • St. Joseph Heritage Healthcare
  • Advanced Medical Research, LLC
  • Arthritis and Osteoporosis Medical Center
  • Desert Medical Advances
  • East Bay Rheumatology Medical Group, Inc.
  • Millennium Clinical Trials
  • Inland Rheumatology and Osteoporosis Medical Group
  • Inland Rheumatology Clinical Trials, Inc.
  • New England Research Associates
  • Stamford Therapeutics Consortium
  • Clinical Research of West Florida
  • Private Practice of Robert W. Levin
  • SIMEDHealth, LLC Attn: Rheumatology
  • SIMEDHealth, LLC
  • Omega Research MetroWest, LLC
  • Akumin, Inc
  • Akumin Inc
  • West Broward Rheumatology Associates, Inc
  • Akumin Inc.
  • Clinical Research of West Florida
  • AdventHealth Tampa
  • Jefrey D. Lieberman, M.D., P.C.
  • Atlanta Research Center for Rheumatology
  • Institute of Arthritis Research
  • Investigational Drug Services University of Kansas Hospital
  • The University of Kansas Hospital
  • University of Kansas Medical Center
  • Ochsner Clinic Foundation, Baton Rouge
  • University of Michigan Brighton Center for Specialty Care
  • Innovative health Research
  • NYU Langone Ambulatory Care Brooklyn Heights
  • St. Lawrence Health System
  • Feinstein Institute for Medical Research
  • Northshore University Hospital
  • Columbia University Medical Center.
  • Irving Institute for Clinical and Transitional Research
  • St. Lawrence Health System
  • Joint and Muscle Research Institute
  • Arthritis & Rheumatology Center of Oklahoma PLLC
  • West Tennessee Research Institute
  • Gupta, Ramesh C MD
  • Tekton Research
  • Accurate Clinical Management, LLC
  • Rheumatic Disease Clinical Research Center, LLC
  • Accurate Clinical Research
  • Arthritis Clinic of Central Texas
  • Arthritis Northwest, PLLC
  • Centro de Investigaciones Medicas Tucuman
  • Optimus Clinical Research
  • Emeritus Research
  • UZ Leuven
  • Ziekenhuisnetwerk Antwerpen Jan Palfijn (ZNA Jan Palfijn)
  • DCC Sveti Georgi EOOD
  • MHAT Plovdiv AD
  • Umhat Kanev Ad
  • UMHAT "Sv.Ivan Rilski" EAD
  • UMHAT "Sv. Ivan Rilski" EAD
  • Centre intégré de santé et de services sociaux du Bas-Saint-Laurent
  • Centre de Recherche Musculo-Squelettique
  • Anhui Provincial Hospital
  • The Second Xiangya Hospital of Central South University
  • The First Affiliated Hospital of Soochow University
  • Tianjin Medical University General Hospital
  • Peking Union Medical College Hospital
  • Ruijin Hospital- Shanghai Jiaotong University School of Medicine
  • Fudan University Hua Shan Hospital
  • Hospital Pablo Tobon Uribe
  • Centro Integral de Reumatología del Caribe S.A.S - CIRCARIBE S.A.S
  • Bluecare Salud S.A.S Sede Centro Médico Integral Chicó MedPlus CRI
  • Centro de Investigación en Reumatología y Especialidades Médicas SAS - CIREEM SAS
  • Medicity S.A.S.
  • Vseobecna fakultni nemocnice v Praze
  • Nemocnicni lekarna VFN
  • Revmatologicky ustav
  • Hôpital Pitié Salpêtrière, Centre des Maladies Auto-immunes
  • Hôpital Cochin
  • CHU de Bordeaux, Groupe Hospitalier Sud, Hôpital Haut Lévèque
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Schleswig Holstein - Campus Lübeck
  • University General Hospital of Heraklion
  • Laiko General Hospital, University of Athens
  • University Hospital ATTIKON
  • Tuen Mun Hospital
  • Qualiclinic Kft.
  • Debreceni Egyetem Klinikai Kozpont
  • Békés Vármegyei Központi Kórház
  • Fondazione IRCCS Policlinico S.Matteo
  • National Hospital Organization Asahikawa Medical Center
  • Hokkaido University Hospital
  • Tohoku University Hospital
  • Sasebo Chuo Hospital
  • Shinkenko clinic
  • St. Luke's International Hospital
  • National Hospital Organization Chiba-East Hospital
  • National Hospital Organization Kyushu Medical Center
  • Hiroshima University Hospital
  • Ajou University Hospital
  • The Catholic University of Korea Seoul St. Mary's Hospital
  • Kyungpook National University Hospital (KNUH)
  • CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas S.A. de C.V.
  • Morales Vargas Centro de Investigación S.C.
  • Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V
  • Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V
  • Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V
  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
  • Centro Peninsular de Investigación Clínica S.C.P.
  • Investigación y Biomedicina de Chihuahua, Sociedad Civil
  • Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V
  • CINTRE Centro de Investigación y Tratamiento Reumatológico S.C.
  • Centrum Wsparcia Badan Klinicznych
  • Stanislaw Sierakowski Centrum Miriada
  • Szpital Biziela
  • Zespol Poradni Specjalistycznych Reumed, Onyksowa Filia nr 2
  • NZOZ "Lecznica Mak-Med" s.c.
  • Centrum Medyczne MEDENS S.C. Grupowa Praktyka Lekarska
  • Narodowy Instytutu Geriatrii, Reumatologii i Rehabilitacji
  • Mazowieckie Centrum Reumatologii i Osteoporozy M. Przygodzka Spolka jawna
  • Hospital Garcia de Orta, E.P.E
  • Hospital Professor Doutor Fernando da Fonseca, E.P.E
  • Unidade Local de Saude do Alto Minho, E.P.E.
  • Centro Hospitalar Universitario do Porto, E.P.E
  • SC Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL
  • Spitalul Clinic Judetean de Urgenta Cluj-Napoca
  • S.C. Euroclinic Hospital S.A
  • Spitalul Clinic Sf. Maria
  • Institut za Reumatologiju
  • Klinicki Centar Srbije, Klinika za alergologiju i imunologiju
  • Vojnomedicinska akademija, Klinika za reumatologiju
  • Institut Niska Banja, Klinika za Reumatologiju
  • Hospital do Meixoeiro
  • Hospital Germans Trias i Pujol
  • Clinica Sagrada Familia
  • Hospital Universitario Vall d'Hebron
  • Complexo Hospitalario Universitario A Coruna
  • Hospital Quiron Infanta Luisa
  • China Medical University Hospital
  • Kaohsiung Veterans General Hospital
  • Chung Shan Medical University Hospital
  • Taichung Veterans General Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Chang Gung Memorial Hospital Linkou Branch
  • State Institution National Scientific Center "M.D. Strazhesko Institute of Cardiology"
  • Communal non-profitable enterprise "Lviv City Clinical Hospital #4"
  • Multifield Medical Center of Odessa National Medical University
  • CNPE "Odesa Regional Clinical Hospital" of Odesa Regional Council
  • CNPE "Ternopil University Hospital" of Ternopil regional council, Department of Rheumatology
  • Zakarpattia Regional Clinical Hospital n.a. A. Novak
  • CNPE "Vinnytsya regional Clinical Hospital named after N.I.Pirogov Vinnytsia Regional Council"
  • Southampton General Hospital
  • Doncaster Royal Infirmary, Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
  • The Leeds Teaching Hospitals NHS Trust, Chapel Allerton Hospital
  • Guy's and St Thomas' NHS Foundation Trust Guy's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

PF-06700841 15 mg

PF-06700841 30 mg

PF-06700841 45 mg

Arm Description

Placebo

PF-06700841 15 mg

PF-06700841 30 mg

PF-06700841 45 mg

Outcomes

Primary Outcome Measures

Proportion of participants achieving the Systemic Lupus Erythematosus Responder Index (SRI) change of 4 (SRI-4) at Week 52.

Secondary Outcome Measures

Proportion of participants achieving the British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) at Week 52.
Proportion of participants achieving the Lupus Low Disease Activity State (LLDAS) at Week 52.
Proportion of participants achieving a reduction in prednisone (or equivalent) at Week 52.
Proportion of participants achieving SRI-4 at Week 52 and have a sustained reduction of prednisone (or equivalent) at Week 52.
Percentage of Participants with Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) Total Activity Score ≥10 at Baseline with ≥50% Reduction in CLASI-A Total Activity Score
Change from baseline in the total scores of Functional Assessment of Chronic Illness Therapy Fatigue (FACIT F) at Week 52.
Change from baseline in the total scores of the Lupus Quality of Life (LupusQoL) at Week 52.
Time to first severe flare in PF 06700841 treated participants relative to placebo.
Number of treatment emergent adverse events (AE's)
Number of discontinuations due to AE's
Number of clinically significant abnormalities in vital signs
Number of clinically significant abnormalities in electrocardiograms
Number of clinically significant abnormalities in clinical laboratory values.

Full Information

First Posted
February 15, 2019
Last Updated
August 14, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03845517
Brief Title
A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
Official Title
A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 18, 2019 (Actual)
Primary Completion Date
October 6, 2023 (Anticipated)
Study Completion Date
October 6, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
PF-06700841 15 mg
Arm Type
Experimental
Arm Description
PF-06700841 15 mg
Arm Title
PF-06700841 30 mg
Arm Type
Experimental
Arm Description
PF-06700841 30 mg
Arm Title
PF-06700841 45 mg
Arm Type
Experimental
Arm Description
PF-06700841 45 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
PF-06700841 15 mg
Intervention Description
PF-06700841 15 mg
Intervention Type
Drug
Intervention Name(s)
PF-06700841 30 mg
Intervention Description
PF-06700841 30 mg
Intervention Type
Drug
Intervention Name(s)
PF-06700841 45 mg
Intervention Description
PF-06700841 45 mg
Primary Outcome Measure Information:
Title
Proportion of participants achieving the Systemic Lupus Erythematosus Responder Index (SRI) change of 4 (SRI-4) at Week 52.
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Proportion of participants achieving the British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) at Week 52.
Time Frame
Baseline, Week 52
Title
Proportion of participants achieving the Lupus Low Disease Activity State (LLDAS) at Week 52.
Time Frame
Baseline, Week 52
Title
Proportion of participants achieving a reduction in prednisone (or equivalent) at Week 52.
Time Frame
Baseline, Week 52
Title
Proportion of participants achieving SRI-4 at Week 52 and have a sustained reduction of prednisone (or equivalent) at Week 52.
Time Frame
Week 52
Title
Percentage of Participants with Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) Total Activity Score ≥10 at Baseline with ≥50% Reduction in CLASI-A Total Activity Score
Time Frame
Baseline, Week 52
Title
Change from baseline in the total scores of Functional Assessment of Chronic Illness Therapy Fatigue (FACIT F) at Week 52.
Time Frame
Baseline, Week 52
Title
Change from baseline in the total scores of the Lupus Quality of Life (LupusQoL) at Week 52.
Time Frame
Baseline, Week 52
Title
Time to first severe flare in PF 06700841 treated participants relative to placebo.
Time Frame
Baseline, Week 52
Title
Number of treatment emergent adverse events (AE's)
Time Frame
Baseline through Week 56
Title
Number of discontinuations due to AE's
Time Frame
Baseline through Week 56
Title
Number of clinically significant abnormalities in vital signs
Time Frame
Baseline through Week 56
Title
Number of clinically significant abnormalities in electrocardiograms
Time Frame
Baseline through Week 56
Title
Number of clinically significant abnormalities in clinical laboratory values.
Time Frame
Baseline through Week 56

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 and/or female subjects between ≥18 and ≤75 years of age inclusive. Diagnosis of moderate to severe active Lupus. Receiving a stable dose of methotrexate, azathioprine, leflunomide, mizoribine, mycophenolate/mycophenolic acid, anti-malarials or corticosteroids. Exclusion Criteria: Active renal lupus Severe active central nervous system (CNS) lupus Have cancer or a history of cancer within 5 years of screening. Have a history of thrombosis (venous or arterial) or other vascular complications within the last 6 months, or any history of either recurrent thrombosis or a pulmonary embolus. Active bacterial, viral, fungal, mycobacterial or other infections Psychiatric condition including recent or active suicidal ideation or behavior Have active fibromyalgia/myofascial/chronic pain. Pregnant female subjects; breastfeeding female subjects; females subjects planning to become pregnant during the study; fertile male subjects and WOCBP who are unwilling or unable to use a highly effective method of contraception.
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
UAB Hospital Department of Pharmacy
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
UAB Hospital-Clinical Research Unit (CRU)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
The University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
UAB Department of Medicine Clinical Research Enterprise
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
St. Joseph Heritage Healthcare
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Advanced Medical Research, LLC
City
La Palma
State/Province
California
ZIP/Postal Code
90623
Country
United States
Facility Name
Arthritis and Osteoporosis Medical Center
City
La Palma
State/Province
California
ZIP/Postal Code
90623
Country
United States
Facility Name
Desert Medical Advances
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260-9368
Country
United States
Facility Name
East Bay Rheumatology Medical Group, Inc.
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
Millennium Clinical Trials
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
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
New England Research Associates
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Stamford Therapeutics Consortium
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Clinical Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Private Practice of Robert W. Levin
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
SIMEDHealth, LLC Attn: Rheumatology
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
SIMEDHealth, LLC
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Omega Research MetroWest, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Facility Name
Akumin, Inc
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34685
Country
United States
Facility Name
Akumin Inc
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33703
Country
United States
Facility Name
West Broward Rheumatology Associates, Inc
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Akumin Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Clinical Research of West Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
AdventHealth Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Jefrey D. Lieberman, M.D., P.C.
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Atlanta Research Center for Rheumatology
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Institute of Arthritis Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Investigational Drug Services University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66103
Country
United States
Facility Name
The University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Ochsner Clinic Foundation, Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70836
Country
United States
Facility Name
University of Michigan Brighton Center for Specialty Care
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48116
Country
United States
Facility Name
Innovative health Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
NYU Langone Ambulatory Care Brooklyn Heights
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
St. Lawrence Health System
City
Canton
State/Province
New York
ZIP/Postal Code
13617
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
Northshore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Columbia University Medical Center.
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Irving Institute for Clinical and Transitional Research
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
St. Lawrence Health System
City
Potsdam
State/Province
New York
ZIP/Postal Code
13676
Country
United States
Facility Name
Joint and Muscle Research Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Arthritis & Rheumatology Center of Oklahoma PLLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Facility Name
West Tennessee Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Gupta, Ramesh C MD
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119-5214
Country
United States
Facility Name
Tekton Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Accurate Clinical Management, LLC
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
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
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Arthritis Clinic of Central Texas
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Facility Name
Arthritis Northwest, PLLC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Centro de Investigaciones Medicas Tucuman
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Optimus Clinical Research
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Emeritus Research
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Ziekenhuisnetwerk Antwerpen Jan Palfijn (ZNA Jan Palfijn)
City
Merksem
ZIP/Postal Code
2170
Country
Belgium
Facility Name
DCC Sveti Georgi EOOD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
MHAT Plovdiv AD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Umhat Kanev Ad
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
UMHAT "Sv.Ivan Rilski" EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UMHAT "Sv. Ivan Rilski" EAD
City
Sofia
ZIP/Postal Code
1432
Country
Bulgaria
Facility Name
Centre intégré de santé et de services sociaux du Bas-Saint-Laurent
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
Facility Name
Centre de Recherche Musculo-Squelettique
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Ruijin Hospital- Shanghai Jiaotong University School of Medicine
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Fudan University Hua Shan Hospital
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Hospital Pablo Tobon Uribe
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050034
Country
Colombia
Facility Name
Centro Integral de Reumatología del Caribe S.A.S - CIRCARIBE S.A.S
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080002
Country
Colombia
Facility Name
Bluecare Salud S.A.S Sede Centro Médico Integral Chicó MedPlus CRI
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Centro de Investigación en Reumatología y Especialidades Médicas SAS - CIREEM SAS
City
Bogotá
State/Province
Cundinamarca
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Medicity S.A.S.
City
Bucaramanga
State/Province
Santander
ZIP/Postal Code
680003
Country
Colombia
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Nemocnicni lekarna VFN
City
Praha 2
ZIP/Postal Code
12802
Country
Czechia
Facility Name
Revmatologicky ustav
City
Praha 2
ZIP/Postal Code
12850
Country
Czechia
Facility Name
Hôpital Pitié Salpêtrière, Centre des Maladies Auto-immunes
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
CHU de Bordeaux, Groupe Hospitalier Sud, Hôpital Haut Lévèque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Schleswig Holstein - Campus Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
University General Hospital of Heraklion
City
Heraklion
State/Province
Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
Laiko General Hospital, University of Athens
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
University Hospital ATTIKON
City
Haidari
ZIP/Postal Code
12462
Country
Greece
Facility Name
Tuen Mun Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Qualiclinic Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Békés Vármegyei Központi Kórház
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Fondazione IRCCS Policlinico S.Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
National Hospital Organization Asahikawa Medical Center
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Sasebo Chuo Hospital
City
Sasebo
State/Province
Nagasaki
ZIP/Postal Code
857-1195
Country
Japan
Facility Name
Shinkenko clinic
City
Naha
State/Province
Okinawa
ZIP/Postal Code
900-0015
Country
Japan
Facility Name
St. Luke's International Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
National Hospital Organization Chiba-East Hospital
City
Chiba
ZIP/Postal Code
260-8712
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seocho-gu
State/Province
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital (KNUH)
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas S.A. de C.V.
City
Mexico City
State/Province
Cuauhtémoc
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Morales Vargas Centro de Investigación S.C.
City
León
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
45070
Country
Mexico
Facility Name
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45070
Country
Mexico
Facility Name
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
C.P. 45070
Country
Mexico
Facility Name
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
City
Mexico City
State/Province
Tlalpan
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Centro Peninsular de Investigación Clínica S.C.P.
City
Mérida
State/Province
Yucatán
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Investigación y Biomedicina de Chihuahua, Sociedad Civil
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V
City
Guadalajara
ZIP/Postal Code
45070
Country
Mexico
Facility Name
CINTRE Centro de Investigación y Tratamiento Reumatológico S.C.
City
Mexico City
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Centrum Wsparcia Badan Klinicznych
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-637
Country
Poland
Facility Name
Stanislaw Sierakowski Centrum Miriada
City
Bialystok
ZIP/Postal Code
15-297
Country
Poland
Facility Name
Szpital Biziela
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Zespol Poradni Specjalistycznych Reumed, Onyksowa Filia nr 2
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Facility Name
NZOZ "Lecznica Mak-Med" s.c.
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Facility Name
Centrum Medyczne MEDENS S.C. Grupowa Praktyka Lekarska
City
Sosnowiec
ZIP/Postal Code
41-200
Country
Poland
Facility Name
Narodowy Instytutu Geriatrii, Reumatologii i Rehabilitacji
City
Warszawa
ZIP/Postal Code
02-637
Country
Poland
Facility Name
Mazowieckie Centrum Reumatologii i Osteoporozy M. Przygodzka Spolka jawna
City
Warszawa
ZIP/Postal Code
04-030
Country
Poland
Facility Name
Hospital Garcia de Orta, E.P.E
City
Almada
ZIP/Postal Code
2805-267
Country
Portugal
Facility Name
Hospital Professor Doutor Fernando da Fonseca, E.P.E
City
Amadora
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
Unidade Local de Saude do Alto Minho, E.P.E.
City
Ponte de Lima
ZIP/Postal Code
4990-078
Country
Portugal
Facility Name
Centro Hospitalar Universitario do Porto, E.P.E
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
SC Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL
City
Brasov
State/Province
JUD. Brasov
ZIP/Postal Code
500283
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
City
Cluj-Napoca
State/Province
Jud. Cluj
ZIP/Postal Code
400006
Country
Romania
Facility Name
S.C. Euroclinic Hospital S.A
City
Bucuresti
State/Province
Sector 1
ZIP/Postal Code
014461
Country
Romania
Facility Name
Spitalul Clinic Sf. Maria
City
Bucuresti
ZIP/Postal Code
011172
Country
Romania
Facility Name
Institut za Reumatologiju
City
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Klinicki Centar Srbije, Klinika za alergologiju i imunologiju
City
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Vojnomedicinska akademija, Klinika za reumatologiju
City
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institut Niska Banja, Klinika za Reumatologiju
City
Niska Banja
ZIP/Postal Code
18205
Country
Serbia
Facility Name
Hospital do Meixoeiro
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36200
Country
Spain
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Clinica Sagrada Familia
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Complexo Hospitalario Universitario A Coruna
City
La Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Quiron Infanta Luisa
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Facility Name
China Medical University Hospital
City
Taichung City
State/Province
Taiwan (r.o.c)
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung City
ZIP/Postal Code
81362
Country
Taiwan
Facility Name
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital Linkou Branch
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
State Institution National Scientific Center "M.D. Strazhesko Institute of Cardiology"
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Communal non-profitable enterprise "Lviv City Clinical Hospital #4"
City
Lviv
ZIP/Postal Code
79011
Country
Ukraine
Facility Name
Multifield Medical Center of Odessa National Medical University
City
Odesa
ZIP/Postal Code
65000
Country
Ukraine
Facility Name
CNPE "Odesa Regional Clinical Hospital" of Odesa Regional Council
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
CNPE "Ternopil University Hospital" of Ternopil regional council, Department of Rheumatology
City
Ternopil
ZIP/Postal Code
46002
Country
Ukraine
Facility Name
Zakarpattia Regional Clinical Hospital n.a. A. Novak
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
CNPE "Vinnytsya regional Clinical Hospital named after N.I.Pirogov Vinnytsia Regional Council"
City
Vinnytsia
ZIP/Postal Code
21028
Country
Ukraine
Facility Name
Southampton General Hospital
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Doncaster Royal Infirmary, Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
City
Doncaster
ZIP/Postal Code
DN2 5LT
Country
United Kingdom
Facility Name
The Leeds Teaching Hospitals NHS Trust, Chapel Allerton Hospital
City
Leeds
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
Facility Name
Guy's and St Thomas' NHS Foundation Trust Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
33687069
Citation
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Results Reference
derived
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7931028
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

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