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| ID | Type | Description | Link |
|---|---|---|---|
| 80202135SLE3001 | Other Identifier | Janssen Research & Development, LLC | |
| 2025-523552-31-00 | Registry Identifier | EUCT number |
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The purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nipocalimab | Experimental | Participants will receive nipocalimab up to Week 52 in the double blind treatment period along with standard of care treatments. At Week 52, eligible participants from both studies will have the option to enter an open-label long-term extension (OLE) period, where they will continue to receive nipocalimab until Week 156 or until the study intervention is discontinued. |
|
| Placebo | Placebo Comparator | Participants will receive placebo up to Week 52 in the double blind treatment period along with standard of care treatment. At Week 52, eligible participants from both studies will have the option to enter an OLE period, where they will continue to receive nipocalimab until Week 156 or until the study intervention is discontinued. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nipocalimab | Drug | Nipocalimab will be administered. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 52 | SLE SRI-4 composite response is a composite response of at least a 4 point reduction in SLE Disease Activity Index 2000 (SLEDAI-2K), no British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as no new A or less than or equal to <= 1 new B items compared to baseline, no worsening in Physician's Global Assessment (PGA [greater than {>} 10 percent {%} increase from baseline]). | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving SRI-4 Composite Response at Week 52 with High Baseline IFN Gene Signature (Interferon [IFN] high) | SLE SRI-4 composite response is a composite response of at least a 4 point reduction in SLEDAI-2K, no BILAG-2004 worsening, defined as no new A or <= 1 new B items compared to baseline, no worsening in PGA (> 10% increase from baseline). IFN high is defined as elevated peripheral type 1 IFN gene signature at baseline. |
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Inclusion Criteria:-
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David S Hallegua MD A Professional Corporation | Recruiting | Beverly Hills | California | 90211 | United States | |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Participants will be randomly assigned to one of the 2 identical studies (conducted under this single protocol) to make a total of 300 participants in each study. Participants in each study will be randomly assigned to one of the arms nipocalimab or placebo respectively.
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| Placebo |
| Drug |
Placebo will be administered. |
|
| Standard of care treatment | Drug | Protocol-defined topical and systemic standard of care background treatments. |
|
| Week 52 |
| Percentage of Participants Achieving SRI-4 Composite Response at Week 52 with Sustained Reduction in Oral Glucocorticoid (GC) Dose | SLE SRI-4 composite response is a composite response of at least a 4 point reduction in SLEDAI-2K, no BILAG-2004 worsening, defined as no new A or <= 1 new B items compared to baseline, no worsening in PGA (> 10% increase from baseline). Sustained reduction in oral GC dose at Week 52 is defined as achieving <= 5 mg/day oral prednisone (or equivalent) AND no increase of that dose from Week 32 through Week 52. | Week 52 |
| Percentage of Participants Who Achieve Lupus Low Disease Activity State (LLDAS) At Week 52 | LLDAS is defined as follows: SLEDAI-2K <= 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity measured as maintaining a D (no disease activity but suggests the system had previously been affected) or E (no current or previous disease activity) score in BILAG gastrointestinal body system, no new lupus disease activity compared with the previous assessment measured as no new or worsening individual BILAG parameters, physician's global assessment of disease activity <= 1 on a 3-point visual analog scale from no disease activity to severe disease activity, a current prednisolone (or equivalent) dose <= 7.5 milligram (mg) daily and well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents. | Week 52 |
| Percentage of Participants with < 2 Active Joints at Week 52 in Participants with >= 2 Active Joints at Baseline | Percentage of participants with < 2 active joints at Week 52 in participants with >= 2 active joints at baseline will be reported. | Week 52 |
| Change From Baseline in Lupus Symptoms Joint Pain Score at Week 52 | Lupus symptoms joint pain score at Week 52 will be reported. | Baseline, Week 52 |
| Percentage of Participants Achieving Sustained Reduction in Oral GC Dose at Week 52 in Participants Treated with Oral GC >5 mg/Day Prednisone (or equivalent) at Baseline | Percentage of participants achieving sustained reduction in oral GC dose at Week 52 in participants treated with oral GC >5 mg/Day prednisone (or equivalent) at baseline will be reported. | Week 52 |
| Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT) Fatigue Score at Week 52 | FACIT-Fatigue version 4.0 is a 13-item questionnaire that assesses participant-reported fatigue and its impact upon daily activities and function over the past 7 days. Participants will be asked to answer each question using a 5-point Likert scale (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; and 4=Very much). FACIT-Fatigue has a total score range from 0 to 52, with 0 being the worst possible score and 52 the best. | Baseline, Week 52 |
| Percentage of Participants With BILAG Flare Free Status Through Week 52 | A participant has a flare-free status if no flare has been reported during the 52-week treatment period. A flare was defined as either 1 or more new BILAG-2004 A (severe disease activity) or 2 or more new BILAG-2004 B (moderate disease activity) items compared to the previous visit. | Up to Week 52 |
| Percentage of Participants Achieving SRI-4 Composite Response at Week 52 with High Baseline Autoantibodies (Autoantibody High) | SLE SRI-4 composite response is a composite response of at least a 4 point reduction in SLEDAI-2K, no BILAG-2004 worsening, defined as no new A or <= 1 new B items compared to baseline, no worsening in PGA (> 10% increase from baseline). Autoantibody high participants is defined as participants with high autoantibody at baseline. | Week 52 |
| Southland Arthritis and Osteoporosis Medical Center Inc dba Southland Arthritis |
| Recruiting |
| Hemet |
| California |
| 92543 |
| United States |
| Advanced Medical Research | Recruiting | La Palma | California | 90623 | United States |
| Solace Clinical Research California | Recruiting | Tustin | California | 92780 | United States |
| Inland Rheumatology Clinical Trials Inc. | Recruiting | Upland | California | 91786 | United States |
| Arthritis & Rheumatic Disease Specialties | Recruiting | Aventura | Florida | 33180 | United States |
| Clinical Research of West Florida 1 | Recruiting | Clearwater | Florida | 33765 | United States |
| Avanti Clinical Research Corp | Recruiting | Hialeah | Florida | 33013 | United States |
| LeJenue Research Associates PLLC | Recruiting | Miami | Florida | 33126 | United States |
| Pro-Care Research Center, Corp. | Recruiting | Miami Gardens | Florida | 33014 | United States |
| Floridian Clinical Research LLC | Recruiting | Miami Lakes | Florida | 33016 | United States |
| Clinical Research of West Florida | Recruiting | Tampa | Florida | 33606 | United States |
| Atlanta Research Center for Rheumatology | Recruiting | Marietta | Georgia | 30060 | United States |
| Willow Rheumatology and Wellness PLLC | Recruiting | Willowbrook | Illinois | 60527 | United States |
| Accurate Clinical Research, Inc. | Recruiting | Lake Charles | Louisiana | 70605 | United States |
| Revive Research Institute | Recruiting | Sterling Heights | Michigan | 48313 | United States |
| Joint and Muscle Research Institute | Recruiting | Charlotte | North Carolina | 28204 | United States |
| DJL Clinical Research, PLLC | Recruiting | Charlotte | North Carolina | 28211 | United States |
| Cross Creek Medical Clinic | Recruiting | Fayetteville | North Carolina | 28304 4422 | United States |
| Paramount Medical Research & Consulting | Recruiting | Middleburg Heights | Ohio | 44130 | United States |
| Clinical Research Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19114 | United States |
| West Tennessee Research Institute | Recruiting | Jackson | Tennessee | 38305 | United States |
| Arthritis and Rheumatology Research Institute | Recruiting | Allen | Texas | 75013 | United States |
| Amarillo Center for Clinical Research | Recruiting | Amarillo | Texas | 79124 | United States |
| R and H Clinical Research | Recruiting | Katy | Texas | 77449 | United States |
| Southwest Rheumatology Research LLC | Recruiting | Mesquite | Texas | 75150 | United States |
| Texas Rheumatology Research Institute LLC | Recruiting | Plano | Texas | 75024 | United States |
| Epic Medical Research 1 | Recruiting | Red Oak | Texas | 75154 | United States |
| Fort Bend Rheumatology Associates PLLC | Recruiting | Sugar Land | Texas | 77479 | United States |
| ARCIS Salud SRL Aprillus asistencia e investigacion | Recruiting | Buenos Aires | C1406AGA | Argentina |
| Centro Privado de Medicina Familiar | Recruiting | Buenos Aires | C1417EYG | Argentina |
| Centro de Investigacion en Enfermedades Reumaticas CIER | Recruiting | Ciudad de Buenos Aires | C1055 | Argentina |
| Arsema | Recruiting | Ciudad de Buenos Aires | C1427 | Argentina |
| Global Psy Asociacion Civil | Recruiting | La Plata | B1904 | Argentina |
| Cer Instituto Medico | Recruiting | Quilmes | B1878DVB | Argentina |
| Instituto de Investigaciones Clinicas Quilmes | Recruiting | Quilmes | B1878GEG | Argentina |
| MR Medicina Reumatologica | Recruiting | San Fernando | B1646GHP | Argentina |
| Centro de Investigaciones Medicas Tucuman | Recruiting | San Miguel de Tucumán | T4000AXL | Argentina |
| Footscray Hospital, Western Health | Recruiting | Footscray | 3011 | Australia |
| Ipswich Hospital | Recruiting | Ipswich | 4305 | Australia |
| Hospital das Clinicas - UFG | Recruiting | Goiânia | 74605-020 | Brazil |
| CMIP - Centro Mineiro de Pesquisa Ltda | Recruiting | Juiz de Fora | 36010 570 | Brazil |
| Hospital De Clinicas De Porto Alegre | Recruiting | Porto Alegre | 90035-903 | Brazil |
| LMK Servicos Medicos S S | Recruiting | Porto Alegre | 90480 000 | Brazil |
| Associacao Hospitalar Moinhos de Vento | Recruiting | Porto Alegre | 90560032 | Brazil |
| Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS | Recruiting | Porto Alegre | 90610 000 | Brazil |
| SER - Servicos Especializados em Reumatologia da Bahia | Recruiting | Salvador | 40150 150 | Brazil |
| Fundacao do ABC Centro Universitario FMABC | Recruiting | Santo André | 09060 870 | Brazil |
| Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base | Recruiting | São José do Rio Preto | 15090 000 | Brazil |
| ESHO Empresa De Servicos Hospitalares S A | Recruiting | São Paulo | 01232 010 | Brazil |
| CEDOES Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda | Recruiting | Vitória | 29055 450 | Brazil |
| MC Medtech Services Ltd | Recruiting | Haskovo | 6304 | Bulgaria |
| Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv | Recruiting | Plovdiv | 4004 | Bulgaria |
| Diagnostic consulting center 1 Ruse EOOD | Recruiting | Rousse | 7002 | Bulgaria |
| Diagnostic-Consultative Center (DCC) Aleksandrovska | Recruiting | Sofia | 1431 | Bulgaria |
| Medical Center Hera EOOD | Recruiting | Sofia | 1510 | Bulgaria |
| Military Medical Academy Multiprofile Hospital for Active Treatment Sofia | Recruiting | Sofia | 1606 | Bulgaria |
| UMHAT 'Sveti Ivan Rilsky' | Recruiting | Sofia | 1612 | Bulgaria |
| University Multi Profile Hospital for Active Treatment UMHAT St. Marina | Recruiting | Varna | 9010 | Bulgaria |
| Peking University People's Hospital | Recruiting | Beijing | 100044 | China |
| West China School of Medicine/West China Hospital, Sichuan University | Recruiting | Cheng Du Shi | 610041 | China |
| Dongguan People s Hospital | Recruiting | Dongguan | 523109 | China |
| The Second Affiliated Hospital of Zhejiang University College of Medicine | Recruiting | Hangzhou | 311608 | China |
| Jinhua municipal central hospital | Recruiting | Jinhua | 321013 | China |
| Shandong Jining No.1 People's Hospital | Recruiting | Jining | 272073 | China |
| Linfen Central Hospital | Recruiting | Linfen | 041000 | China |
| Ningbo medical center lihuili hospital | Recruiting | Ningbo | 315041 | China |
| Shenshan Medical Center Memorial Hospital of Sun Yat Sen University | Recruiting | Shanwei | 516601 | China |
| Second Affiliated Hospital, SooChow University | Recruiting | Suzhou | 215004 | China |
| Shanxi Bethune Hospital | Recruiting | Taiyuan | 030032 | China |
| Revimex Pro s r o | Recruiting | Karvina Frystat | 733 01 | Czechia |
| Revmatologicky ustav | Recruiting | Prague | 128 50 | Czechia |
| Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
| Zealand University Hospital | Recruiting | Køge | 4600 | Denmark |
| Helsinki University Hospital | Recruiting | Helsinki | 00290 | Finland |
| Northern Clinical Trial Coordinators | Recruiting | Oulu | 90150 | Finland |
| Centre Hospitalier Le Mans | Recruiting | Le Mans | 72037 | France |
| CHU Toulouse - Hopital de Rangueil | Recruiting | Toulouse | 31400 | France |
| Universitätsklinikum Carl-Gustav-Carus Dresden | Recruiting | Dresden | 01307 | Germany |
| CAIR Heidelberg | Recruiting | Heidelberg | 69121 | Germany |
| Klinikum der Universitaet Muenchen | Recruiting | München | 80336 | Germany |
| Medicover Muenchen Ost MVZ | Recruiting | München | 81667 | Germany |
| Laiko General Hospital of Athens | Recruiting | Athens | 115 27 | Greece |
| University General Hospital Attikon General Hospital Of West Attica H Agia Varvara | Recruiting | Athens | 12461 | Greece |
| University General Hospital of Heraklion | Recruiting | Heraklion | 715 00 | Greece |
| General University Hospital Of Larissa | Recruiting | Larissa | 41110 | Greece |
| Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz | Recruiting | Budapest | 1027 | Hungary |
| Vita Verum Medical Egeszsegugyi Szolgaltato Bt | Recruiting | Székesfehérvár | 8000 | Hungary |
| Vital Medical Center Orvosi es Fogaszati Kozpont | Recruiting | Veszprém | 8200 | Hungary |
| Obudai Egeszsegugyi Centrum Kft | Recruiting | Zalaegerszeg | 8900 | Hungary |
| Bnai Zion Medical Center | Recruiting | Haifa | 31048 | Israel |
| Rambam Health Care Campus | Recruiting | Haifa | 3109601 | Israel |
| Carmel Medical Center | Recruiting | Haifa | 3436212 | Israel |
| Hadassah Ein-Qarem Medical Center | Recruiting | Jerusalem | 9112001 | Israel |
| Meir Medical Center | Recruiting | Kfar Saba | 4428164 | Israel |
| Galilee Medical Center | Recruiting | Nahariya | 2210001 | Israel |
| Tel Aviv Sourasky Medical Center | Recruiting | Tel Aviv | 6423906 | Israel |
| Azienda Ospedaliero Universitaria Delle Marche | Recruiting | Ancona | 60126 | Italy |
| Istituto Clinico Humanitas | Recruiting | Rozzano | 20089 | Italy |
| Tokai University Hospital | Recruiting | Isehara | 259-1193 | Japan |
| Shinkenko Clinic | Recruiting | Naha | 900 0015 | Japan |
| Kitano Hospital | Recruiting | Osaka | 530-8480 | Japan |
| Hokkaido University Hospital | Recruiting | Sapporo | 060-8648 | Japan |
| St. Luke's International Hospital | Recruiting | Tokyo | 104 8560 | Japan |
| Hospital Sultan Ismail | Recruiting | Johor Bahru | 81100 | Malaysia |
| Hospital Sultanah Nur Zahirah | Recruiting | Kuala | 20400 | Malaysia |
| University Malaya Medical Centre | Recruiting | Kuala Lumpur | 59100 | Malaysia |
| Hospital Umum Sarawak | Recruiting | Kuching | 93586 | Malaysia |
| Sunway Medical Centre | Recruiting | Petaling Jaya | 47500 | Malaysia |
| Hospital Taiping | Recruiting | Taiping | 34000 | Malaysia |
| Haukeland University Hospital | Recruiting | Bergen | 5009 | Norway |
| Oslo universitetssykehus HF, Rikshospitalet | Recruiting | Oslo | 0372 | Norway |
| Stavanger University Hospital | Recruiting | Stavanger | 4011 | Norway |
| MICS Centrum Medyczne Bydgoszcz | Recruiting | Bydgoszcz | 85 065 | Poland |
| Jan Biziel's University Hospital | Recruiting | Bydgoszcz | 85 168 | Poland |
| Nzoz Bif Med | Recruiting | Bytom | 41 902 | Poland |
| Provita Sp z o o | Recruiting | Katowice | 40 611 | Poland |
| Malopolskie Badania Kliniczne Sp z o o | Recruiting | Krakow | 30-002 | Poland |
| NZOZ Lecznica MAK MED S C | Recruiting | Nadarzyn | 05 830 | Poland |
| Twoja Przychodnia - Centrum Medyczne Nowa Sol | Recruiting | Nowa Sól | 67 100 | Poland |
| Twoja Przychodnia Poznanskie Centrum Medyczne | Recruiting | Poznan | 60-324 | Poland |
| Innova Clinic sp z o o | Recruiting | Płońsk | 09 100 | Poland |
| MICS Centrum Medyczne Warszawa | Recruiting | Warsaw | 00-874 | Poland |
| Rheuma Medicus Sp z o o | Recruiting | Warsaw | 02 118 | Poland |
| Uls Almada Seixal - Hosp. Garcia de Orta | Recruiting | Almada | 2805 267 | Portugal |
| Uls Sao Jose - Hosp. Curry Cabral | Recruiting | Lisbon | 1069 166 | Portugal |
| Uls Santa Maria - Hosp. Santa Maria | Recruiting | Lisbon | 1649 028 | Portugal |
| Ulsam - Hosp. Conde de Bertiandos | Recruiting | Ponte de Lima | 4990-041 | Portugal |
| Centrul Medical de Diagnostic si Tratament Ambulator NEOMED | Recruiting | Brasov | 500283 | Romania |
| Spitalul Clinic Sfanta Maria | Recruiting | Bucharest | 011172 | Romania |
| Spitalul Clinic Judetean de Urgenta Cluj | Recruiting | Cluj-Napoca | 400006 | Romania |
| Medisof Diagnostic S R L | Recruiting | Craiova | 200347 | Romania |
| Spitalul Clinic Judetean de Urgenta Bihor | Recruiting | Oradea | 410469 | Romania |
| Medbanat s r l | Recruiting | Timișoara | 300766 | Romania |
| MEDMAN s.r.o. | Recruiting | Martin | 036 01 | Slovakia |
| Narodny Ustav Reumatickych Chorob | Recruiting | Piešťany | 921 12 | Slovakia |
| Chonnam National University Hospital | Recruiting | Gwangju | 61469 | South Korea |
| Seoul National University Bundang Hospital | Recruiting | Gyeonggi-do | 13620 | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| Ajou University Hospital | Recruiting | Suwon | 16499 | South Korea |
| Hospital Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hosp. de La Santa Creu I Sant Pau | Recruiting | Barcelona | 8026 | Spain |
| Hosp. Gral. Juan Ramon Jimenez | Recruiting | Huelva | 21005 | Spain |
| Hosp. Univ. Infanta Leonor | Recruiting | Madrid | 28031 | Spain |
| Complejo Hosp de Navarra - Hosp de Navarra | Recruiting | Pamplona | 31008 | Spain |
| Hosp. Univ. Marques de Valdecilla | Recruiting | Santander | 39008 | Spain |
| Hosp. Clinico Univ. de Santiago | Recruiting | Santiago de Compostela | 15706 | Spain |
| Hosp. Univ. Rio Hortega | Recruiting | Valladolid | 47012 | Spain |
| NTU Biomedical Park Hospital | Recruiting | Hsinchu | 302058 | Taiwan |
| Kaohsiung Veterans General Hospital | Recruiting | Kaohsiung City | 813414 | Taiwan |
| Kaohsiung Chang Gung Memorial Hospital | Recruiting | Kaohsiung City | 83301 | Taiwan |
| National Taiwan University Hospital | Recruiting | Taipei | 10043 | Taiwan |
| Taipei Veterans General Hospital | Recruiting | Taipei | 11217 | Taiwan |
| Linkou Chang Gung Memorial Hospital | Recruiting | Taoyuan | 333 | Taiwan |
| Phramongkutklao Hospital | Recruiting | Bangkok | 10400 | Thailand |
| Ramathibodi Hospital Mahidol University | Recruiting | Bangkok | 10400 | Thailand |
| Maharaj Nakorn Chiang Mai Hospital | Recruiting | Chiang Mai | 50200 | Thailand |
| Ankara University Medical Faculty | Recruiting | Ankara | 06050 | Turkey (Türkiye) |
| Ankara Bilkent Sehir Hastanesi | Recruiting | Ankara | 06800 | Turkey (Türkiye) |
| Firat University Hospital | Recruiting | Elâzığ | 23200 | Turkey (Türkiye) |
| Sanko Universitesi Hastanesi | Recruiting | Gaziantep | 27090 | Turkey (Türkiye) |
| Marmara University Istanbul Pendik Education and Research Hospital | Recruiting | Istanbul | 34899 | Turkey (Türkiye) |
| Necmettin Erbakan University Meram Medical Faculty | Recruiting | Konya | 42080 | Turkey (Türkiye) |
| Newcastle Freeman Hospital | Recruiting | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Peterborough City Hospital | Recruiting | Peterborough | PE3 9GZ | United Kingdom |
| Royal Berkshire Hospital | Recruiting | Reading | RG1 5LE | United Kingdom |
| Southampton University Hospital | Recruiting | Southampton | SO16 6HU | United Kingdom |
| Haywood Hospital | Recruiting | Stoke-on-Trent | ST6 7AG | United Kingdom |
| Great Western Hospital | Recruiting | Swindon | SN3 6BB | United Kingdom |
| 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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