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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523488-39 | Registry Identifier | CTIS | |
| U1111-1329-5843 | Registry Identifier | WHO - International Clinical Trials Registry Platform (ICTRP) |
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This study is open to adults with systemic lupus erythematosus (SLE). The purpose of this study is to find out whether a medicine called BI 3000202 helps people with SLE. The study tests different doses of BI 3000202 and aims to find the best dose for people with this condition.
Participants are put into 5 groups randomly, which means by chance. 4 groups get different doses of BI 3000202, and 1 group gets a placebo. Placebo tablets look like BI 3000202 tablets but do not contain any medicine. Participants take the tablets for 1 year. All participants also continue their regular treatment for SLE.
Participants are in the study for a bit longer than 1 year. During this time, they visit the study site regularly. Doctors check the participants' health and take note of any unwanted effects. They also compare the results between the groups to see if the treatment works.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: BI 3000202 dose 1 | Experimental |
| |
| Arm 2: BI 3000202 dose 2 | Experimental |
| |
| Arm 3: BI 3000202 dose 3 | Experimental |
| |
| Arm 4: BI 3000202 dose 4 | Experimental |
| |
| Arm 5: Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 3000202 | Drug | BI 3000202 at different doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response | At Week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of SRI-4 response | At Week 52 | |
| Achievement of SRI-4 response and oral corticosteroid reduction to ≤5 mg/day prednisone or equivalent | At Week 32 | |
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Inclusion Criteria:
Male and female adult patients from ≥18 years (or alternative age for adults based on local regulations) to <75 years
Confirmed Systemic Lupus Erythematosus (SLE) diagnosis meeting the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria at least 24 weeks prior to screening
At least one of the following positive at screening: Antinuclear Antibodies (ANA) ≥1:80 or anti-double-stranded Deoxyribonucleic Acid (dsDNA) antibody or anti-Smith antibody
- Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 points and clinical SLEDAI-2K score ≥4 points
At least 1 British Isles Lupus Assessment Group (BILAG) A and/or 1 BILAG B grade at screening, with sufficient disease activity according to both investigator and adjudicator
On SLE background therapy with a maximum of 1 immunosuppressant and/or 1 antimalarial for ≥8 weeks and at a stable dose for ≥4 weeks before screening and/or oral corticosteroids at a dose of ≤30 mg/day prednisone or equivalent, stable for ≥2 weeks before screening (Visit 1) Further inclusion criteria apply.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim | Contact | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wallace & Lee Center | Not yet recruiting | Beverly Hills | California | 90210 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
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| Placebo | Drug | Placebo matching BI 3000202 |
|
| Achievement of Lupus Low Disease Activity State (LLDAS) |
| At Week 32 |
| Arthritis & Osteoporosis Medical Center, Inc - La Palma | Not yet recruiting | La Palma | California | 90623 | United States |
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| University of California San Diego | Not yet recruiting | San Diego | California | 92037 | United States |
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| University of California Los Angeles | Not yet recruiting | Torrance | California | 90509 | United States |
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| Inland Rheumatology Clinical Trials, Inc | Not yet recruiting | Upland | California | 91786 | United States |
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| Focus Clinical Research | Not yet recruiting | West Hills | California | 91307 | United States |
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| Denver Arthritis Clinic - Lowry | Not yet recruiting | Denver | Colorado | 80230 | United States |
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| AARDS Research, Inc. | Not yet recruiting | Aventura | Florida | 33180 | United States |
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| Meris Clinical Research-Brandon-69466 | Not yet recruiting | Brandon | Florida | 33511 | United States |
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| Clinical Research of West Florida, Inc. | Not yet recruiting | Clearwater | Florida | 33763 | United States |
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| Integral Rheumatology and Immunology Specialist | Not yet recruiting | Plantation | Florida | 33324 | United States |
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| Clinical Research of West Florida, Inc. - Tampa | Not yet recruiting | Tampa | Florida | 33606 | United States |
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| AA MRC LLC - Grand Blanc | Not yet recruiting | Grand Blanc | Michigan | 48439 | United States |
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| June DO, PC | Not yet recruiting | Lansing | Michigan | 48911 | United States |
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| Oscar Clinical Trials | Not yet recruiting | Jackson | Mississippi | 39206 | United States |
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| Boeson Research - Great Falls | Not yet recruiting | Great Falls | Montana | 59405 | United States |
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| DJL Clinical Research, PLLC | Not yet recruiting | Charlotte | North Carolina | 28211 | United States |
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| Cross Creek Medical Clinic, PA | Not yet recruiting | Fayetteville | North Carolina | 28304 | United States |
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| Paramount Medical Research and Consulting | Not yet recruiting | Middleburg Heights | Ohio | 44130 | United States |
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| Oklahoma Medical Research Foundation | Not yet recruiting | Oklahoma City | Oklahoma | 73104 | United States |
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| Altoona Arthritis & Osteoporosis Center - Altoona Center for Clinical Research | Not yet recruiting | Duncansville | Pennsylvania | 16635 | United States |
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| West Tennessee Research Institute | Not yet recruiting | Jackson | Tennessee | 38305 | United States |
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| Shelby Research LLC | Not yet recruiting | Memphis | Tennessee | 38119 | United States |
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| Arthritis & Rheumatology Institute - Allen | Not yet recruiting | Allen | Texas | 75013 | United States |
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| Amarillo Center for Clinical Research | Not yet recruiting | Amarillo | Texas | 79124 | United States |
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| Precision Comprehensive Clinical Research Solutions - Colleyville | Not yet recruiting | Colleyville | Texas | 76034 | United States |
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| Precision Comprehensive Clinical Research Solutions | Not yet recruiting | Euless | Texas | 76040 | United States |
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| The University of Texas Health Science Center at Houston | Not yet recruiting | Houston | Texas | 77030 | United States |
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| R&H Clinical Research - Katy | Not yet recruiting | Katy | Texas | 77449 | United States |
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| SouthWest Rheumatology Research | Not yet recruiting | Mesquite | Texas | 75150 | United States |
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| Centro Medico Reumatologico - OMI | Not yet recruiting | CABA | 1015 | Argentina |
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| Instituto de Investigación ClÃnica TyT | Not yet recruiting | CABA | C1405BFN | Argentina |
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| Instituto Médico Especializado | Not yet recruiting | Capital Federal | C1405BCH | Argentina |
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| Consultora integral en Salud SRL. | Not yet recruiting | General Paz | 5000 | Argentina |
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| Sanatorio Maipú | Not yet recruiting | Maipu | M5515DQA | Argentina |
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| Instituto de Investigaciones Clinicas Quilmes | Not yet recruiting | Quilmes | B1878 | Argentina |
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| Centro de Investigaciones Médicas Tucumán | Not yet recruiting | San Miguel de Tucumán | 4000 | Argentina |
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| Austin Health | Not yet recruiting | Heidelberg | Victoria | 3081 | Australia |
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| Fiona Stanley Hospital | Not yet recruiting | Murdoch | Western Australia | 6150 | Australia |
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| SAPIENS - Instituto de Estudos e Pesquisa ClÃnica | Not yet recruiting | Curitiba | 80810-000 | Brazil |
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| Centro Mineiro de Pesquisa (CMIP) | Not yet recruiting | Juiz de Fora | 36010-570 | Brazil |
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| Hospitalar Moinhos de Vento | Not yet recruiting | Porto Alegre | 90035-001 | Brazil |
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| Inovace Pesquisa ClÃnica | Not yet recruiting | Salvador | 41820-000 | Brazil |
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| Fundação Faculdade Regional de Medicina de São José do Rio Preto | Not yet recruiting | São José do Rio Preto | 15090-000 | Brazil |
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| CEPIC - Centro Paulista de Investigacao Clinica e Servicos | Recruiting | São Paulo | 04266-010 | Brazil |
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| Azidus Centro de Pesquisa Clinica Avancada | Not yet recruiting | Valinhos | 13271-130 | Brazil |
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| Medical Center MedTech Services Ltd. | Not yet recruiting | Haskovo | 6304 | Bulgaria |
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| Military medical academy - MHAT Pleven | Not yet recruiting | Pleven | 5800 | Bulgaria |
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| Medical Complex Sveti Ivan Rilski EOOD | Not yet recruiting | Plovdiv | 4003 | Bulgaria |
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| Hospital MHAT Plovdiv, AD | Not yet recruiting | Plovdiv | 4027 | Bulgaria |
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| Medical center "Medici Sofia" Ltd. | Not yet recruiting | Sofia | 1113 | Bulgaria |
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| Diagnostic Consultative Center Alexandrovska | Not yet recruiting | Sofia | 1431 | Bulgaria |
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| Medical Center Hera EOOD | Not yet recruiting | Sofia | 1510 | Bulgaria |
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| University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD | Not yet recruiting | Sofia | 1612 | Bulgaria |
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| Peking Union Medical College Hospital | Recruiting | Beijing | 100730 | China |
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| Jilin Province People's Hospital | Recruiting | Changchun | 130021 | China |
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| Xiangya Hospital, Central South University | Not yet recruiting | Changsha | 410008 | China |
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| The third affiliated hospital of Sun Yat-Sen University | Not yet recruiting | Guangzhou | 510630 | China |
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| Linfen Central Hospital | Not yet recruiting | Linfen | 041000 | China |
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| Nanjing Drum Tower Hospital | Not yet recruiting | Nanjing | 210008 | China |
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| The First Affiliated Hospital of Ningbo University | Recruiting | Ningbo | 315010 | China |
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| Huashan Hospital, Fudan University | Not yet recruiting | Shanghai | 200040 | China |
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| Renji Hospital Shanghai Jiaotong Univesrity School of Medicine | Not yet recruiting | Shanghai | 200040 | China |
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| The Second Affiliated Hospital of Soochow University | Not yet recruiting | Suzhou | 215004 | China |
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| The First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | Wenzhou | 325000 | China |
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| ClÃnica de la Costa SAS | Not yet recruiting | Barranquilla | 080020 | Colombia |
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| CIREEM SAS (Centro de Investigación en ReumatologÃa y Especialidades Médicas) | Not yet recruiting | Bogotá | 110231 | Colombia |
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| Hospital Universitario San Ignacio de Bogotá | Not yet recruiting | Bogotá | 110231 | Colombia |
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| IPS Centro Medico Julián Coronel S.A. | Not yet recruiting | Cali | 760001 | Colombia |
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| Fundacion Oftalmologica de Santander FOSCAL | Not yet recruiting | Floridablanca | 681001 | Colombia |
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| Klinicki Bolnicki Centar Osijek | Not yet recruiting | Osijek | 31000 | Croatia |
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| Specijalna Bolnica Medico | Not yet recruiting | Rijeka | 51000 | Croatia |
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| Poliklinika Bonifarm Zagreb | Not yet recruiting | Zagreb | 10000 | Croatia |
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| Solmed Polyclinic | Not yet recruiting | Zagreb | 1000 | Croatia |
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| Rheumazentrum Prof. Dr. med. Gunther Neeck | Not yet recruiting | Bad Doberan | 18209 | Germany |
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| Mühlenkreiskliniken AöR | Not yet recruiting | Minden | 32429 | Germany |
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| Klinikum der Universität München AÖR | Not yet recruiting | München | 80336 | Germany |
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| Semmelweis University | Not yet recruiting | Budapest | 1021 | Hungary |
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| Vita Verum Medical Bt. | Not yet recruiting | Székesfehérvár | 8000 | Hungary |
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| CARE, Kochi | Not yet recruiting | Kochi | 682040 | India |
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| IPGMER and SSKM Hospital | Not yet recruiting | Kolkata | 700020 | India |
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| Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute | Not yet recruiting | Maharashtra | 400053 | India |
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| Japan Community Healthcare Organization Chukyo Hospital | Not yet recruiting | Aichi, Nagoya | 457-8510 | Japan |
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| National Hospital Organization Chibahigashi National Hospital | Not yet recruiting | Chiba, Chiba | 260-8712 | Japan |
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| Juntendo University Urayasu Hospital | Not yet recruiting | Chiba, Urayasu | 279-0021 | Japan |
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| Hospital of the University of Occupational and Environmental Health | Not yet recruiting | Fukuoka, Kitakyushu | 807-8556 | Japan |
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| Hokkaido University Hospital | Not yet recruiting | Hokkaido, Sapporo | 060-8648 | Japan |
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| Tohoku Medical and Pharmaceutical University Hospital | Not yet recruiting | Miyagi, Sendai | 983-8512 | Japan |
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| University of Miyazaki Hospital | Not yet recruiting | Miyazaki, Miyazaki | 889-1692 | Japan |
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| Shinshu University Hospital | Not yet recruiting | Nagano, Matsumoto | 390-8621 | Japan |
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| Niigata University Medical and Dental Hospital | Not yet recruiting | Niigata, Niigata | 951-8520 | Japan |
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| Japanese Red Cross Okayama Hospital | Not yet recruiting | Okayama, Okayama | 700-8607 | Japan |
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| Saitama Medical University Hospital | Not yet recruiting | Saitama, Iruma-gun | 350-0495 | Japan |
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| Juntendo University Hospital | Not yet recruiting | Tokyo, Bunkyo-ku | 113-8431 | Japan |
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| Institute of Science Tokyo Hospital | Not yet recruiting | Tokyo, Bunkyo-ku | 113-8519 | Japan |
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| St. Luke's International Hospital | Not yet recruiting | Tokyo, Chuo-ku | 104-8560 | Japan |
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| Keio University Hospital | Not yet recruiting | Tokyo, Shinjuku-ku | 160-8582 | Japan |
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| Investigacion y Biomedicina de Chihuahua S.C. | Not yet recruiting | Chihuahua City | 31020 | Mexico |
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| Mediadvance Clinical S.A.P.I de C.V. | Not yet recruiting | Chihuahua City | 31203 | Mexico |
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| Centro Médico ISSEMyM Ecatepec | Not yet recruiting | Ecatepec | 55020 | Mexico |
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| Centro de Investigacion Farmacologica del BajÃo, S.C. | Not yet recruiting | León | 37160 | Mexico |
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| Centro Médico del Angel SC | Not yet recruiting | Mexicali | 21100 | Mexico |
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| Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran | Not yet recruiting | Mexico City | 14080 | Mexico |
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| Cemdeicy, S.C.P. | Not yet recruiting | Mérida | 97130 | Mexico |
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| CIMAB S.A. de C.V | Not yet recruiting | Torreón | 27000 | Mexico |
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| Erasmus Medisch Centrum | Not yet recruiting | Rotterdam | 3015 GD | Netherlands |
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| Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy | Not yet recruiting | Bydgoszcz | 85-168 | Poland |
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| Intercor | Not yet recruiting | Bydgoszcz | 85605 | Poland |
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| Pratia S.A. | Not yet recruiting | Krakow | 30-727 | Poland |
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| Medical Center Hetmanska | Not yet recruiting | Poznan | 60-218 | Poland |
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| Prywatna Praktyka Lekarska Paweł Piesiak | Not yet recruiting | Poznan | 61-397 | Poland |
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| ai medical center LLC | Not yet recruiting | Poznan | 61113 | Poland |
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| Medicover Integrated Clinical Services Sp. z o.o. | Not yet recruiting | Warsaw | 00874 | Poland |
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| Klinika Reuma Park Sp. z o.o. S.K. | Not yet recruiting | Warsaw | 02665 | Poland |
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| Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy | Not yet recruiting | Warsaw | 04-141 | Poland |
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| Pracownia Badan Klinicznych Salus | Not yet recruiting | Wroclaw | 53034 | Poland |
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| Delta Health Care | Not yet recruiting | Bucharest | 014142 | Romania |
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| Spitalul Clinic Dr. I. Cantacuzino | Not yet recruiting | Bucharest | 020475 | Romania |
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| Centrul Clinic De Boli Reumatismale Dr. Ion Stoia | Not yet recruiting | Bucharest | 020983 | Romania |
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| Institutul Clinic Fundeni | Not yet recruiting | Bucharest | 022328 | Romania |
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| Military Medical Academy | Not yet recruiting | Belgrade | 11000 | Serbia |
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| General Hospital - Djordje Joanovic | Not yet recruiting | Zrenjanin | 23101 | Serbia |
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| Dr Gareth Scott Tarr | Not yet recruiting | Stellenbosch | 7599 | South Africa |
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| Hospital Germans Trias i Pujol | Not yet recruiting | Badalona | 08916 | Spain |
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| Hospital Santa Creu i Sant Pau | Not yet recruiting | Barcelona | 08041 | Spain |
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| Hospital de Galdakao | Recruiting | Galdakao | 48960 | Spain |
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| Hospital Universitario Ramon Y Cajal | Not yet recruiting | Madrid | 28034 | Spain |
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| Hospital Universitario de Araba | Not yet recruiting | Vitoria-Gasteiz | 01009 | Spain |
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| Chang Gung Memorial Hospital - Kaohsiung | Recruiting | Kaohsiung City | 833 | Taiwan |
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| Chung Shan Medical University Hospital | Not yet recruiting | Taichung | 40201 | Taiwan |
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| National Taiwan University Hospital | Not yet recruiting | Taipei | 100225 | Taiwan |
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| Taipei Medical University Hospital | Not yet recruiting | Taipei | 110 | Taiwan |
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| Taipei Veterans General Hospital | Not yet recruiting | Taipei | 112201 | Taiwan |
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| Basingstoke and North Hampshire Hospital | Not yet recruiting | Basingstoke | RG24 9NA | United Kingdom |
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| Belfast City Hospital | Not yet recruiting | Belfast | BT9 7AB | United Kingdom |
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| Doncaster Royal Infirmary | Not yet recruiting | Doncaster | DN2 5LTT | United Kingdom |
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| Guy's Hospital | Not yet recruiting | London | SE1 9RT | United Kingdom |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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