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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519278-37 | Other Identifier | EU CTR |
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The purpose of this study is to evaluate the efficacy, safety and drug levels of CC-97540 in participants with active systemic lupus erythematosus (SLE) including lupus nephritis with inadequate response to glucocorticoids and at least 2 immunosuppressants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of CC-97540 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-97540 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving drug-free Definition of Remission in Systemic Lupus Erythematosus (DORIS) remission | At month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete renal response (CRR) for participants with baseline lupus nephritis (LN) | Up to Month 60 | |
| Participants with drug-free DORIS remission | Up to month 60 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0106 | Not yet recruiting | Phoenix | Arizona | 85054 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
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| Fludarabine | Drug | Specified dose on specified days |
|
| Cyclophosphamide | Drug | Specified dose on specified days |
|
| CRR for participants with baseline LN |
| Up to month 60 |
| Modified CRR for participants with baseline LN | Up to month 60 |
| Number of participants achieving Lupus Low Disease Activity State (LLDAS) with baseline Systemic Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) ≥6 | Up to month 60 |
| Number of participants achieving SLE Responder Index (SRI) - 4 with baseline SLEDAI ≥6 | Up to month 60 |
| Number of participants with flares as assessed by SLEDAI flare index | Up to month 60 |
| Severity of participants with flares as assessed by SLEDAI flare index | Up to month 60 |
| Change from baseline in proteinuria | Up to month 60 |
| Change from baseline in estimated glomerular filtration rate (eGFR) | Up to month 60 |
| Change from baseline in Systemic Lupus International Collaborating Clinics (SLICC)/ACR (American College of Rheumatology) damage index | Up to month 60 |
| Percentage of participants achieving maintenance of drug-free DORIS remission | Up to month 60 |
| Percentage of participants achieving maintenance of LLDAS | Up to month 60 |
| Percentage of participants achieving maintenance of SRI-4 | Up to month 60 |
| Time from first response to loss of response for drug-free DORIS remission | Up to month 60 |
| Time from first response to loss of response for LLDAS | Up to month 60 |
| Time from first response to loss of response for SRI-4 | Up to month 60 |
| Time from baseline to first drug-free DORIS remission | Up to month 60 |
| Time from baseline to LLDAS | Up to month 60 |
| Time from baseline to SRI-4 | Up to month 60 |
| Duration of drug-free status | Up to month 60 |
| Percentage of participants achieving DORIS remission regardless of drug-free status | Up to month 60 |
| Glucocorticoid used post-infusion for SLE treatment | Up to month 60 |
| Change of serum autoantibodies from baseline | Up to month 60 |
| Change in complement factor (C3 and C4) levels from baseline | Up to month 60 |
| Change from baseline in patient reported outcomes (PRO) as assessed by FACIT-Fatigue | Up to month 60 |
| Change from baseline in PRO as assessed by SF 36 v2 Acute | Up to month 60 |
| Change from baseline in PRO as assessed by EQ-5D-5L | Up to month 60 |
| Change from baseline in PRO as assessed by Patient Global Impression of Severity (PGI-S) Pain | Up to month 60 |
| Change from baseline in PRO as assessed by PGI-S Fatigue | Up to month 60 |
| Patient Global Impression of Change (PGI-C) Pain | Up to month 60 |
| PGI-C Fatigue | Up to month 60 |
| Number of participants with Adverse Events (AEs) | Up to month 60 |
| Number of participants with serious AEs (SAEs) | Up to month 60 |
| Number of participants with AESIs (AEs of Special Interest) | Up to month 60 |
| Number of participants with clinically significant laboratory abnormalities | Up to month 60 |
| Local Institution - 0038 | Not yet recruiting | Los Angeles | California | 90027 | United States |
|
| Local Institution - 0051 | Not yet recruiting | Los Angeles | California | 90095 | United States |
|
| Local Institution - 0093 | Not yet recruiting | Newport Beach | California | 92663 | United States |
|
| Lucile Packard Children's Hospital | Recruiting | Palo Alto | California | 94304 | United States |
|
| University of Colorado Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
|
| Local Institution - 0105 | Not yet recruiting | Denver | Colorado | 80218 | United States |
|
| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
|
| University of Miami Hospital and Clinics, Sylvester Cancer Center | Recruiting | Miami | Florida | 33136 | United States |
|
| Local Institution - 0073 | Not yet recruiting | Orlando | Florida | 32803 | United States |
|
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
|
| USF Health | Recruiting | Tampa | Florida | 33612 | United States |
|
| Florida Medical Clinic Orlando Health | Recruiting | Zephyrhills | Florida | 33542 | United States |
|
| Emory University School of Medicine | Recruiting | Atlanta | Georgia | 30322 | United States |
|
| Local Institution - 0079 | Not yet recruiting | Atlanta | Georgia | 30322 | United States |
|
| Northside Hospital | Recruiting | Atlanta | Georgia | 30342 | United States |
|
| Local Institution - 0108 | Not yet recruiting | Indianapolis | Indiana | 46250 | United States |
|
| Local Institution - 0086 | Not yet recruiting | Baton Rouge | Louisiana | 70836 | United States |
|
| Local Institution - 0110 | Not yet recruiting | Shreveport | Louisiana | 71101 | United States |
|
| Local Institution - 0094 | Not yet recruiting | Boston | Massachusetts | 02114 | United States |
|
| Local Institution - 0096 | Not yet recruiting | Ann Arbor | Michigan | 48109 | United States |
|
| Local Institution - 0011 | Not yet recruiting | Rochester | Minnesota | 55905 | United States |
|
| Atlantic Health System Overlook Medical Center | Recruiting | Summit | New Jersey | 07901 | United States |
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| Local Institution - 0101 | Not yet recruiting | Manhasset | New York | 11030 | United States |
|
| Local Institution - 0082 | Not yet recruiting | New York | New York | 10016 | United States |
|
| Hospital for Special Surgery | Recruiting | New York | New York | 10021 | United States |
|
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
|
| Columbia University Irving Medical Center | Recruiting | New York | New York | 10032 | United States |
|
| Local Institution - 0095 | Not yet recruiting | New York | New York | 10032 | United States |
|
| Weill Cornell Medical College | Recruiting | New York | New York | 10065 | United States |
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| Local Institution - 0111 | Not yet recruiting | Stony Brook | New York | 11794 | United States |
|
| Carolinas HealthCare System SouthPark | Recruiting | Charlotte | North Carolina | 28211 | United States |
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| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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| Local Institution - 0083 | Not yet recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| Baptist Memorial Hospital | Recruiting | Memphis | Tennessee | 38120 | United States |
|
| Baylor Scott and White Research Institute | Recruiting | Dallas | Texas | 75246 | United States |
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| Local Institution - 0098 | Not yet recruiting | Dallas | Texas | 75390-9068 | United States |
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| Local Institution - 0104 | Not yet recruiting | San Antonio | Texas | 78229 | United States |
|
| Swedish Medical Center | Recruiting | Seattle | Washington | 98122 | United States |
|
| Hospital Italiano de Buenos Aires | Recruiting | ABB | Buenos Aires F.D. | C1199ABB | Argentina |
|
| Hospital Aleman | Recruiting | Buenos Aires | Buenos Aires F.D. | C1118AAT | Argentina |
|
| Local Institution - 0107 | Not yet recruiting | Buenos Aires | B1629ODT | Argentina |
|
| Local Institution - 0077 | Not yet recruiting | Córdoba | X5016 | Argentina |
|
| Medizinische Universität Wien | Recruiting | Vienna | State of Vienna | 1090 | Austria |
|
| Uniklinikum Salzburg | Recruiting | Salzburg | 5020 | Austria |
|
| UZ Leuven | Recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
|
| Local Institution - 0021 | Not yet recruiting | São Paulo | São Paulo | 01409-001 | Brazil |
|
| Local Institution - 0058 | Not yet recruiting | São Paulo | São Paulo | 01509-010 | Brazil |
|
| Local Institution - 0022 | Not yet recruiting | São Paulo | 05652-900 | Brazil |
|
| Vancouver General Hospital | Recruiting | Vancouver | British Columbia | V5Z 1M9 | Canada |
|
| The Hospital for Sick Children | Recruiting | Toronto | Ontario | M5G 1X8 | Canada |
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| Local Institution - 0099 | Not yet recruiting | Toronto | Ontario | M5T 2S8 | Canada |
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| Local Institution - 0047 | Not yet recruiting | Copenhagen | Capital Region | 2100 | Denmark |
|
| Local Institution - 0132 | Not yet recruiting | Odense | Region Syddanmark | 5000 | Denmark |
|
| Odense Universitetshospital | Recruiting | Odense | Region Syddanmark | 5000 | Denmark |
|
| Local Institution - 0081 | Not yet recruiting | Toulouse | Haute-Garonne | 31059 | France |
|
| CHU Montpellier Lapeyronie Hospital | Recruiting | Montpellier | Hérault | 34295 | France |
|
| Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou | Recruiting | Rennes | 35033 | France |
|
| Local Institution - 0109 | Not yet recruiting | Strasbourg | 67098 | France |
|
| Pitie Salpetriere University Hospital | Recruiting | Paris | Île-de-France Region | 75013 | France |
|
| Universitätsklinikum Leipzig | Recruiting | Leipzig | Saxony | 04103 | Germany |
|
| Universitaetsklinikum Magdeburg | Recruiting | Magdeburg | Saxony-Anhalt | 39120 | Germany |
|
| Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin | Recruiting | Berlin | 10117 | Germany |
|
| Universitaetsklinikum Koeln | Recruiting | Cologne | 50937 | Germany |
|
| Universitaetsklinikum Erlangen | Recruiting | Erlangen | 91054 | Germany |
|
| Local Institution - 0084 | Not yet recruiting | Herne | 44649 | Germany |
|
| Sheba Medical Center | Recruiting | Ramat Gan | Central District | 5262100 | Israel |
|
| Hadassah Medical Center | Recruiting | Jerusalem | 9112001 | Israel |
|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore | Recruiting | Rome | Lazio | 00168 | Italy |
|
| ASST Grande Ospedale Metropolitano Niguarda | Recruiting | Milan | Milano | 20162 | Italy |
|
| Local Institution - 0044 | Not yet recruiting | Rome | Roma | 00165 | Italy |
|
| Local Institution - 0070 | Not yet recruiting | Pisa | Tuscany | 56126 | Italy |
|
| Hokkaido University Hospital | Recruiting | Sapporo | Hokkaido | 0608648 | Japan |
|
| Yokohama City University Hospital | Recruiting | Yokohama | Kanagawa | 236-0004 | Japan |
|
| Juntendo University Hospital | Recruiting | Bunkyo-ku | Tokyo | 113-8431 | Japan |
|
| Keio university hospital | Recruiting | Shinjuku-ku | Tokyo | 1608582 | Japan |
|
| Chiba University Hospital | Recruiting | Chiba | 260-8677 | Japan |
|
| Kyushu University Hospital | Recruiting | Fukuoka | 812-8582 | Japan |
|
| Okayama University Hospital | Recruiting | Okayama | 700-8558 | Japan |
|
| Osaka Metropolitan University Hospital | Recruiting | Osaka | 545-8586 | Japan |
|
| Szpital Specjalistyczny nr 1 w Bytomiu | Recruiting | Bytom | Silesian Voivodeship | 41-902 | Poland |
|
| Narodowy Instytut Onkologii - Oddzial w Gliwicach | Recruiting | Gliwice | Silesian Voivodeship | 44-101 | Poland |
|
| Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria | Recruiting | Lisbon | Lisbon District | 1649-035 | Portugal |
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| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
|
| Hospital Sant Joan de Déu | Recruiting | Esplugues de Llobregat | Barcelona [Barcelona] | 08950 | Spain |
|
| Local Institution - 0088 | Not yet recruiting | Donostia / San Sebastian | Gipuzkoa | 20014 | Spain |
|
| Hospital La Princesa | Recruiting | Madrid | 28006 | Spain |
|
| H.R.U Málaga - Hospital General | Recruiting | Málaga | 29011 | Spain |
|
| Hospital Clínico Universitario Virgen de la Arrixaca | Recruiting | Murcia | 30120 | Spain |
|
| Local Institution - 0061 | Withdrawn | London | London, City of | NW1 2PG | United Kingdom |
| University College London Hospital | Recruiting | London | London, City of | NW1 2PG | United Kingdom |
|
| King's College Hospital | Recruiting | London | London, City of | SE5 9RL | United Kingdom |
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| Local Institution - 0090 | Not yet recruiting | Metropolitan Borough of Wirral | Merseyside | L63 4JY | United Kingdom |
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| Derriford Hospital, University Hospitals Plymouth NHS Trust | Recruiting | Crownhill, Plymouth | PL6 8DH | United Kingdom |
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| Local Institution - 0091 | Not yet recruiting | Liverpool | L9 7AL | United Kingdom |
|
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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