A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
Study Purpose
Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.
Recruitment Criteria
|
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years - 75 Years |
| Gender | All |
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.
Trial Details
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03845517 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Pfizer |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Pfizer CT.gov Call Center |
| Principal Investigator Affiliation | Pfizer |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Argentina, Australia, Belgium, Bulgaria, Canada, China, Colombia, Czechia, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Korea, Republic of, Mexico, Poland, Portugal, Romania, Serbia, Spain, Taiwan, Ukraine, United Kingdom, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Systemic Lupus Erythematosus |
| Study Website: | View Trial Website |
Arms
Placebo Comparator: Placebo
Placebo
Experimental: PF-06700841 15 mg
PF-06700841 15 mg
Experimental: PF-06700841 30 mg
PF-06700841 30 mg
Experimental: PF-06700841 45 mg
PF-06700841 45 mg
Interventions
Drug: - Placebo
Placebo
Drug: - PF-06700841 15 mg
PF-06700841 15 mg
Drug: - PF-06700841 30 mg
PF-06700841 30 mg
Drug: - PF-06700841 45 mg
PF-06700841 45 mg
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Active, not recruiting
Address
UAB Hospital Department of Pharmacy
Birmingham, Alabama, 35249
Status
Active, not recruiting
Address
UAB Hospital-Clinical Research Unit (CRU)
Birmingham, Alabama, 35249
Status
Active, not recruiting
Address
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
Status
Active, not recruiting
Address
UAB Department of Medicine Clinical Research Enterprise
Birmingham, Alabama, 35294
Status
Active, not recruiting
Address
St. Joseph Heritage Healthcare
Fullerton, California, 92835
Status
Active, not recruiting
Address
Advanced Medical Research, LLC
La Palma, California, 90623
Status
Active, not recruiting
Address
Arthritis and Osteoporosis Medical Center
La Palma, California, 90623
Status
Active, not recruiting
Address
Desert Medical Advances
Palm Desert, California, 92260-9368
Status
Active, not recruiting
Address
East Bay Rheumatology Medical Group, Inc.
San Leandro, California, 94578
Status
Active, not recruiting
Address
Millennium Clinical Trials
Thousand Oaks, California, 91360
Status
Active, not recruiting
Address
Inland Rheumatology and Osteoporosis Medical Group
Upland, California, 91786
Status
Active, not recruiting
Address
Inland Rheumatology Clinical Trials, Inc.
Upland, California, 91786
Status
Terminated
Address
New England Research Associates
Bridgeport, Connecticut, 06606
Status
Terminated
Address
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905
Status
Active, not recruiting
Address
Clinical Research of West Florida
Clearwater, Florida, 33765
Status
Active, not recruiting
Address
Private Practice of Robert W. Levin
Clearwater, Florida, 33765
Status
Terminated
Address
SIMEDHealth, LLC Attn: Rheumatology
Gainesville, Florida, 32607
Status
Terminated
Address
SIMEDHealth, LLC
Gainesville, Florida, 32607
Status
Active, not recruiting
Address
Omega Research MetroWest, LLC
Orlando, Florida, 32808
Status
Active, not recruiting
Address
Akumin, Inc
Palm Harbor, Florida, 34685
Status
Active, not recruiting
Address
Akumin Inc
Saint Petersburg, Florida, 33703
Status
Active, not recruiting
Address
West Broward Rheumatology Associates, Inc
Tamarac, Florida, 33321
Status
Active, not recruiting
Address
Akumin Inc.
Tampa, Florida, 33603
Status
Active, not recruiting
Address
Clinical Research of West Florida
Tampa, Florida, 33606
Status
Active, not recruiting
Address
AdventHealth Tampa
Tampa, Florida, 33613
Status
Active, not recruiting
Address
Jefrey D. Lieberman, M.D., P.C.
Decatur, Georgia, 30033
Status
Active, not recruiting
Address
Atlanta Research Center for Rheumatology
Marietta, Georgia, 30060
Status
Active, not recruiting
Address
Institute of Arthritis Research
Idaho Falls, Idaho, 83404
Status
Active, not recruiting
Address
Investigational Drug Services University of Kansas Hospital
Kansas City, Kansas, 66103
Status
Active, not recruiting
Address
The University of Kansas Hospital
Kansas City, Kansas, 66160
Status
Active, not recruiting
Address
University of Kansas Medical Center
Kansas City, Kansas, 66160
Status
Active, not recruiting
Address
Ochsner Clinic Foundation, Baton Rouge
Baton Rouge, Louisiana, 70836
Status
Active, not recruiting
Address
University of Michigan Brighton Center for Specialty Care
Brighton, Michigan, 48116
Status
Active, not recruiting
Address
Innovative health Research
Las Vegas, Nevada, 89128
Status
Active, not recruiting
Address
NYU Langone Ambulatory Care Brooklyn Heights
Brooklyn, New York, 11201
Status
Terminated
Address
St. Lawrence Health System
Canton, New York, 13617
Status
Active, not recruiting
Address
Feinstein Institute for Medical Research
Manhasset, New York, 11030
Status
Active, not recruiting
Address
Northshore University Hospital
Manhasset, New York, 11030
Status
Active, not recruiting
Address
Columbia University Medical Center.
New York, New York, 10032
Status
Active, not recruiting
Address
Irving Institute for Clinical and Transitional Research
New York, New York, 10032
Status
Terminated
Address
St. Lawrence Health System
Potsdam, New York, 13676
Status
Active, not recruiting
Address
Joint and Muscle Research Institute
Charlotte, North Carolina, 28204
Status
Active, not recruiting
Address
Arthritis & Rheumatology Center of Oklahoma PLLC
Oklahoma City, Oklahoma, 73102
Status
Active, not recruiting
Address
West Tennessee Research Institute
Jackson, Tennessee, 38305
Status
Active, not recruiting
Address
Gupta, Ramesh C MD
Memphis, Tennessee, 38119-5214
Status
Active, not recruiting
Address
Tekton Research
Austin, Texas, 78745
Status
Active, not recruiting
Address
Accurate Clinical Management, LLC
Baytown, Texas, 77521
Status
Terminated
Address
Rheumatic Disease Clinical Research Center, LLC
Houston, Texas, 77004
Status
Terminated
Address
Accurate Clinical Research
Houston, Texas, 77089
Status
Terminated
Address
Arthritis Clinic of Central Texas
San Marcos, Texas, 78666
Status
Active, not recruiting
Address
Arthritis Northwest, PLLC
Spokane, Washington, 99204
International Sites
Status
Active, not recruiting
Address
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucuman, Tucuman, T4000AXL
Status
Active, not recruiting
Address
Optimus Clinical Research
Kogarah, New South Wales, 2217
Status
Active, not recruiting
Address
Emeritus Research
Camberwell, Victoria, 3124
Status
Active, not recruiting
Address
UZ Leuven
Leuven, , 3000
Status
Active, not recruiting
Address
Ziekenhuisnetwerk Antwerpen Jan Palfijn (ZNA Jan Palfijn)
Merksem, , 2170
Status
Active, not recruiting
Address
DCC Sveti Georgi EOOD
Plovdiv, , 4000
Status
Active, not recruiting
Address
MHAT Plovdiv AD
Plovdiv, , 4000
Status
Active, not recruiting
Address
Umhat Kanev Ad
Ruse, , 7002
Status
Active, not recruiting
Address
UMHAT "Sv.Ivan Rilski" EAD
Sofia, , 1431
Status
Active, not recruiting
Address
UMHAT "Sv. Ivan Rilski" EAD
Sofia, , 1432
Status
Active, not recruiting
Address
Centre intégré de santé et de services sociaux du Bas-Saint-Laurent
Rimouski, Quebec, G5L 5T1
Status
Active, not recruiting
Address
Centre de Recherche Musculo-Squelettique
Trois-Rivieres, Quebec, G8Z 1Y2
Status
Recruiting
Address
Anhui Provincial Hospital
Hefei, Anhui, 230001
Status
Recruiting
Address
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Status
Recruiting
Address
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Status
Recruiting
Address
Tianjin Medical University General Hospital
Tianjin, Tianjin, 300052
Status
Recruiting
Address
Peking Union Medical College Hospital
Beijing, , 100730
Status
Recruiting
Address
Ruijin Hospital- Shanghai Jiaotong University School of Medicine
Shanghai, , 200025
Status
Recruiting
Address
Fudan University Hua Shan Hospital
Shanghai, , 200040
Status
Active, not recruiting
Address
Hospital Pablo Tobon Uribe
Medellin, Antioquia, 050034
Status
Active, not recruiting
Address
Centro Integral de Reumatología del Caribe S.A.S - CIRCARIBE S.A.S
Barranquilla, Atlantico, 080002
Status
Active, not recruiting
Address
Bluecare Salud S.A.S Sede Centro Médico Integral Chicó MedPlus CRI
Bogota, Cundinamarca, 110221
Status
Active, not recruiting
Address
Centro de Investigación en Reumatología y Especialidades Médicas SAS - CIREEM SAS
Bogotá, Cundinamarca, 110221
Status
Active, not recruiting
Address
Medicity S.A.S.
Bucaramanga, Santander, 680003
Status
Terminated
Address
Vseobecna fakultni nemocnice v Praze
Praha 2, , 128 08
Status
Terminated
Address
Nemocnicni lekarna VFN
Praha 2, , 12802
Status
Active, not recruiting
Address
Revmatologicky ustav
Praha 2, , 12850
Status
Active, not recruiting
Address
Hôpital Pitié Salpêtrière, Centre des Maladies Auto-immunes
Paris, , 75013
Status
Active, not recruiting
Address
Hôpital Cochin
Paris, , 75014
Status
Active, not recruiting
Address
CHU de Bordeaux, Groupe Hospitalier Sud, Hôpital Haut Lévèque
Pessac, , 33604
Status
Terminated
Address
Medizinische Hochschule Hannover
Hannover, , 30625
Status
Active, not recruiting
Address
Universitätsklinikum Schleswig Holstein - Campus Lübeck
Lübeck, , 23538
Status
Active, not recruiting
Address
University General Hospital of Heraklion
Heraklion, Crete, 71110
Status
Active, not recruiting
Address
Laiko General Hospital, University of Athens
Athens, , 11527
Status
Active, not recruiting
Address
University Hospital ATTIKON
Haidari, , 12462
Status
Active, not recruiting
Address
Tuen Mun Hospital
Hong Kong, ,
Status
Active, not recruiting
Address
Qualiclinic Kft.
Budapest, , 1036
Status
Active, not recruiting
Address
Debreceni Egyetem Klinikai Kozpont
Debrecen, , 4032
Status
Active, not recruiting
Address
Békés Megyei Központi Kórház Pándy Kálmán Tagkórház
Gyula, , 5700
Status
Active, not recruiting
Address
Fondazione IRCCS Policlinico S.Matteo
Pavia, , 27100
Status
Not yet recruiting
Address
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi, 460-0001
Status
Not yet recruiting
Address
Hospital of the university of occupational and environmental health
Kitakyushu-shi, Fukuoka, 807-8556
Status
Recruiting
Address
National Hospital Organization Asahikawa Medical Center
Asahikawa, Hokkaido, 070-8644
Status
Recruiting
Address
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
Status
Recruiting
Address
Tohoku University Hospital
Sendai, Miyagi, 980-8574
Status
Recruiting
Address
Sasebo Chuo Hospital
Sasebo, Nagasaki, 857-1195
Status
Recruiting
Address
Shinkenko clinic
Naha, Okinawa, 900-0015
Status
Recruiting
Address
St. Luke's International Hospital
Chuo-ku, Tokyo, 104-8560
Status
Not yet recruiting
Address
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, 141-8625
Status
Recruiting
Address
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582
Status
Recruiting
Address
National Hospital Organization Chiba-East Hospital
Chiba, , 260-8712
Status
Recruiting
Address
National Hospital Organization Kyushu Medical Center
Fukuoka, , 810-8563
Status
Recruiting
Address
Hiroshima University Hospital
Hiroshima, , 734-8551
Status
Not yet recruiting
Address
Nagasaki University Hospital
Nagasaki, , 852-8501
Status
Active, not recruiting
Address
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
Status
Active, not recruiting
Address
The Catholic University of Korea Seoul St. Mary's Hospital
Seocho-gu, Seoul, 06591
Status
Active, not recruiting
Address
Kyungpook National University Hospital (KNUH)
Daegu, , 41944
Status
Active, not recruiting
Address
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas S.A. de C.V.
Mexico City, Cuauhtémoc, 06700
Status
Active, not recruiting
Address
Morales Vargas Centro de Investigación S.C.
León, Guanajuato, 37000
Status
Active, not recruiting
Address
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Tlalpan, 14080
Status
Active, not recruiting
Address
Centro Peninsular de Investigación Clínica S.C.P.
Mérida, Yucatán, 97000
Status
Active, not recruiting
Address
Investigación y Biomedicina de Chihuahua, Sociedad Civil
Chihuahua, , 31000
Status
Active, not recruiting
Address
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V
Guadalajara, , 45070
Status
Active, not recruiting
Address
CINTRE Centro de Investigación y Tratamiento Reumatológico S.C.
Mexico City, , 11850
Status
Active, not recruiting
Address
Centrum Wsparcia Badan Klinicznych
Warszawa, Mazowieckie, 02-637
Status
Active, not recruiting
Address
Stanislaw Sierakowski Centrum Miriada
Bialystok, , 15-297
Status
Active, not recruiting
Address
Szpital Biziela
Bydgoszcz, , 85-168
Status
Active, not recruiting
Address
Zespol Poradni Specjalistycznych Reumed, Onyksowa Filia nr 2
Lublin, , 20-582
Status
Active, not recruiting
Address
NZOZ "Lecznica Mak-Med" s.c.
Nadarzyn, , 05-830
Status
Active, not recruiting
Address
Centrum Medyczne MEDENS S.C. Grupowa Praktyka Lekarska
Sosnowiec, , 41-200
Status
Active, not recruiting
Address
Narodowy Instytutu Geriatrii, Reumatologii i Rehabilitacji
Warszawa, , 02-637
Status
Active, not recruiting
Address
Mazowieckie Centrum Reumatologii i Osteoporozy M. Przygodzka Spolka jawna
Warszawa, , 04-030
Status
Active, not recruiting
Address
Hospital Garcia de Orta, E.P.E
Almada, , 2805-267
Status
Active, not recruiting
Address
Hospital Professor Doutor Fernando da Fonseca, E.P.E
Amadora, , 2720-276
Status
Active, not recruiting
Address
Unidade Local de Saude do Alto Minho, E.P.E.
Ponte de Lima, , 4990-078
Status
Active, not recruiting
Address
Centro Hospitalar Universitario do Porto, E.P.E
Porto, , 4099-001
Status
Active, not recruiting
Address
SC Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL
Brasov, JUD. Brasov, 500283
Status
Active, not recruiting
Address
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Cluj-Napoca, Jud. Cluj, 400006
Status
Active, not recruiting
Address
S.C. Euroclinic Hospital S.A
Bucuresti, Sector 1, 014461
Status
Active, not recruiting
Address
Spitalul Clinic Sf. Maria
Bucuresti, , 011172
Status
Active, not recruiting
Address
Institut za Reumatologiju
Beograd, , 11000
Status
Active, not recruiting
Address
Klinicki Centar Srbije, Klinika za alergologiju i imunologiju
Beograd, , 11000
Status
Active, not recruiting
Address
Vojnomedicinska akademija, Klinika za reumatologiju
Beograd, , 11000
Status
Active, not recruiting
Address
Institut Niska Banja, Klinika za Reumatologiju
Niska Banja, , 18205
Status
Active, not recruiting
Address
Hospital do Meixoeiro
Vigo, Pontevedra, 36200
Status
Active, not recruiting
Address
Hospital Germans Trias i Pujol
Badalona, , 08916
Status
Active, not recruiting
Address
Clinica Sagrada Familia
Barcelona, , 08022
Status
Active, not recruiting
Address
Hospital Universitario Vall d'Hebron
Barcelona, , 08035
Status
Active, not recruiting
Address
Complexo Hospitalario Universitario A Coruna
La Coruna, , 15006
Status
Active, not recruiting
Address
Hospital Quiron Infanta Luisa
Sevilla, , 41010
Status
Active, not recruiting
Address
China Medical University Hospital
Taichung City, Taiwan (r.o.c), 40447
Status
Active, not recruiting
Address
Kaohsiung Veterans General Hospital
Kaohsiung City, , 81362
Status
Active, not recruiting
Address
Chung Shan Medical University Hospital
Taichung, , 40201
Status
Active, not recruiting
Address
Taichung Veterans General Hospital
Taichung, , 40705
Status
Active, not recruiting
Address
National Taiwan University Hospital
Taipei, , 100
Status
Active, not recruiting
Address
Taipei Veterans General Hospital
Taipei, , 11217
Status
Active, not recruiting
Address
Chang Gung Memorial Hospital Linkou Branch
Taoyuan City, , 333
Status
Active, not recruiting
Address
State Institution National Scientific Center "M.D. Strazhesko Institute of Cardiology"
Kyiv, , 03680
Status
Active, not recruiting
Address
Communal non-profitable enterprise "Lviv City Clinical Hospital #4"
Lviv, , 79011
Status
Active, not recruiting
Address
Multifield Medical Center of Odessa National Medical University
Odesa, , 65000
Status
Active, not recruiting
Address
CNPE "Odesa Regional Clinical Hospital" of Odesa Regional Council
Odesa, , 65025
Status
Active, not recruiting
Address
CNPE "Ternopil University Hospital" of Ternopil regional council, Department of Rheumatology
Ternopil, , 46002
Status
Active, not recruiting
Address
Zakarpattia Regional Clinical Hospital n.a. A. Novak
Uzhgorod, , 88000
Status
Active, not recruiting
Address
CNPE "Vinnytsya regional Clinical Hospital named after N.I.Pirogov Vinnytsia Regional Council"
Vinnytsia, , 21028
Status
Active, not recruiting
Address
Southampton General Hospital
Southampton, Hampshire, SO16 6YD
Status
Active, not recruiting
Address
Doncaster Royal Infirmary, Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
Doncaster, , DN2 5LT
Status
Active, not recruiting
Address
The Leeds Teaching Hospitals NHS Trust, Chapel Allerton Hospital
Leeds, , LS7 4SA
Status
Active, not recruiting
Address
Guy's and St Thomas' NHS Foundation Trust Guy's Hospital
London, , SE1 9RT
