Phase
Condition
Arthritis And Arthritic Pain
Rheumatoid Arthritis
Dermatomyositis (Connective Tissue Disease)
Treatment
N/AClinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject has a minimum 1 year history/diagnosis of rheumatoid arthritis based on the 1987 American College of Rheumatology (ACR) Revised criteria for RA.
Subject must have active rheumatoid arthritis despite methotrexate (MTX) therapy of ≥10 mg/wk for at least 12 weeks. The MTX dose must be stable for at least 4 weeksimmediately prior to screening.
Exclusion
Exclusion Criteria:
Subjects who used any of the following systemic treatments during the washout periodsgiven below:
Oral corticosteroid dose of prednisone >7.5 mg/day (or equivalent) or a change indose within 28 days of baseline.
Treatment with more than 1 NSAID within 14 days at baseline.
Methotrexate dose greater than 25 mg/week, or change in the dose of methotrexatewithin 28 days of baseline.
Subjects will be allowed to continue the following non biologic DMARDs:sulfasalazine, hydroxychloroquine, and leflumomide. All other non-biologic DMARDs (including but not limited to gold, penicillamine, azathioprine,cyclophospamide), and biologic DMARDs must have been discontinued at least 2months prior to Week 1.
Any biologic B cell depleting agent (eg, rituximab) within 2 years of Week 1.
Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
Study Design
Connect with a study center
Hospital Santa Izabel - Santa Casa de Misericórdia da Bahia
Salvador, Bahia 40050-410
BrazilSite Not Available
CIP (Centro Internacional de Pesquisa)
Goiania, Goiás 74110-120
BrazilSite Not Available
CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos LTDA
Sao Paulo, SP 04209-003
BrazilSite Not Available
Research Center
Juiz de Fora,
BrazilSite Not Available
Guangdong General Hospital
Guangzhou, Guangdong 510080
ChinaSite Not Available
Chinese Academy of Medical Sciences - Peking Union Medical C
Beijing, 100050
ChinaSite Not Available
Shanghai Changhai Hospital[Rheumatology &Immunology]
Shanghai, 200433
ChinaSite Not Available
Shanghai Changning District Guanghua Hospital of Traditional Chinese and Western Medicine
Shanghai, 200052
ChinaSite Not Available
Centro Integral de reumatolo[Gerencia / Representante Legal]
Barranquilla, Atlántico 99999
ColombiaSite Not Available
Fundacion Instituto de Reumatologia Fernando Chalem
Bogota, Cundinamarca
ColombiaSite Not Available
Fundacion Instituto de Reumatologia Fernando Chalem
Bogota DC, Cundinamarca
ColombiaSite Not Available
Hospital Pablo Tobon Uribe (HPTU)
Antioquia,
ColombiaSite Not Available
Revmatologicka poradna III. Interni nefrologicka, revmatologicka a endokrinologicka klinika
Olomouc, 775 20
Czech RepublicSite Not Available
Revmatologicky ustav
Praha 2, 12850
Czech RepublicSite Not Available
Revmatologicka ambulance
Praha 5, 150 06
Czech RepublicSite Not Available
PV-Medical s.r.o.
Zlin, 760 01
Czech RepublicSite Not Available
New University Hospital, Alexandria Clinical Research Center
Alexandria, Al Iskandariyah 21131
EgyptSite Not Available
Al Azhar University Hospital [Rheumatology]
Cairo, Al Qahirah 12111
EgyptSite Not Available
Ain Shams University/Al Demerdash Hospital/Diabetology Unit
Cairo,
EgyptSite Not Available
Budai Irgalmasrendi Korhaz
Budapest, 1023
HungarySite Not Available
Magyar Honvédség Egészségügyi Központ
Budapest, 1062
HungarySite Not Available
Pharmaceutical Research Center- PRC. Jordan University of Science and Technology
Irbid, 22110
JordanSite Not Available
American University of Beirut Medical Center
Beirut, 1107-2020
LebanonSite Not Available
Queen Elizabeth Hospital
Kota Kinabalu, Sabah 88586
MalaysiaSite Not Available
Hopsital Putrajaya [Medicine]
Putrajaya, Wilayah Persekutuan Putrajaya 62250
MalaysiaSite Not Available
University Malaysia Medical Centre
Kuala Lumpur, 59100
MalaysiaSite Not Available
Centro de Investigación y Atención Integral de Durango, SC
Durango, Durango / Mexico 34080
MexicoSite Not Available
Centro de Alta Especialidad en Reumatología e Investigación
San Luis de Potosi, San Luis Potosí / Mexico 78213
MexicoSite Not Available
Centro Medico Las Americas
Merida, Yucatan
MexicoSite Not Available
Hospital Central
San Luis Potosi, 78290
MexicoSite Not Available
Centro de Alta Especialidad en Reumatología e Investigación
San Luis Potosí, 78213
MexicoSite Not Available
De La Salle University Health Sciences Campus- Clinical Epidemiology Unit
Dasmarinas, Cavite 4114
PhilippinesSite Not Available
St. Luke's Mecical Center
Quezon, Manila 1102
PhilippinesSite Not Available
Angeles University Foundation Medical Center
Angeles City, Pampanga
PhilippinesSite Not Available
Chong Hua Hospital, Medical Arts Center
Cebu City, 6000
PhilippinesSite Not Available
UP-Philippine General Hospital, Medical Research Laboratory, Medicine Department,
Manila, 1000
PhilippinesSite Not Available
Hamad Medical Corporation
Doha, 3050
QatarSite Not Available
Spitalul Clinic "Dr.I Cantacuzino" [Sectia Clinica Medicina
Bucharest, Bucureşti 20475
RomaniaSite Not Available
Spitalul Judetean
Baia Mare, Maramure 4800
RomaniaSite Not Available
Spitalul Clinic Judetean de Urgenta Brasov
Brasov, 500365
RomaniaSite Not Available
Spitalul Clinic de Recuperare
Iasi, 700656
RomaniaSite Not Available
Spitalul Clinic Judetean de Urgenta Targu Mures
Tg Mures, 540136
RomaniaSite Not Available
LLC Research Medical Complex Your Health based on City Clinical Hospital Number 7 (Actual address)
Kazan, 420137
Russian FederationSite Not Available
LLC Research Medical Complex Your Health based on City Clinical Hospital Number 7(Legal address)
Kazan, 420097
Russian FederationSite Not Available
Krasnoyarsk State Medical University named after Professor V.F. Voyno-Yasenetsky
Krasnoyarsk, 660014
Russian FederationSite Not Available
Krasnoyarsk State Medical University named after Professor V.F. Voyno-Yasenetsky,
Krasnoyarsk, 660022
Russian FederationSite Not Available
FSBSI "Scientific Research Institute of Rheumatology n. a. V.A. Nasonova"
Moscow, 115522
Russian FederationSite Not Available
LLC Institute of Medical Trials (Actual address)
St. Petersburg, 196084
Russian FederationSite Not Available
Al Habib Hospital, Reuhmatology
Riyadh,
Saudi ArabiaSite Not Available
Universitas Hospital [Cardiololgy]
Bloemfontein, Free State 9301
South AfricaSite Not Available
Vincent Pallotti Hospital
Cape Town, 7405
South AfricaSite Not Available
Winelands Medical Research Centre
Stellenbosch, 7600
South AfricaSite Not Available
Cathay General Hospital
Taiwan, Taoyuan 330
TaiwanSite Not Available
Buddhist Tzu Chi General Hospital - Dalin Branch
Chia-Yi, 62247
TaiwanSite Not Available
China Medical University Hospital, Division of Rheumatology, Allergy and Immunology
Taichung, 404
TaiwanSite Not Available
Taipei Medical University Hospital
Taipei, 11042
TaiwanSite Not Available
Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine,
Amphoe Mueang, Chiang Mai 50200
ThailandSite Not Available
Siriraj Hospital [Rheumatology]
Bangkok, 10700
ThailandSite Not Available
Khon Kaen University (KKU) - Faculty of Medicine
Khon Kaen, 40002
ThailandSite Not Available
Songklanagarind Hospital
Songkla, 90110
ThailandSite Not Available
Republican Clinical Hospital, Department of Internal Medicine #2 of Crimean State Medical University
Simferopol, Crimea 95017
UkraineSite Not Available
Komunalnyi zaklad Kyivskoi oblasnoi rady "Kyivska oblasna klinichna likarnia"
Kyiv, 04107
UkraineSite Not Available
Odessa Regional Clinical Hospital, Outpatient Department
Odessa, 65025
UkraineSite Not Available
Municipal Institution of Ternopil Regional Council Ternopil University Hospital
Ternopil, 46000
UkraineSite Not Available
Vinnitsa Regional Clinical Hospital n.a. Pirogov, Department of Faculty Therapy of Vinnitsa NMU
Vinnitsa, 21018
UkraineSite Not Available
Al Baraha Hospital
Dubai,
United Arab EmiratesSite Not Available

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