A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
NCT ID: NCT01205438
Last Updated: 2018-07-17
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
1124 participants
Study Classification
INTERVENTIONAL
Study Start Date
2011-01-31
Study Completion Date
2015-03-31
Brief Summary
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The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in addition to standard of care therapy in participants with active SLE.
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Detailed Description
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Conditions
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Systemic Lupus Erythematosus
Connective Tissue Disease
Autoimmune Disease
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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LY2127399 every 2 weeks
Group Type
EXPERIMENTAL
LY2127399
Intervention Type
DRUG
120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
LY2127399 every 4 weeks
During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.
Group Type
EXPERIMENTAL
LY2127399
Intervention Type
DRUG
120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
Placebo every 4 weeks
Intervention Type
DRUG
Administered via subcutaneous injection for 52 weeks.
Placebo
Group Type
PLACEBO_COMPARATOR
Placebo every 2 weeks
Intervention Type
DRUG
Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose.
Interventions
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LY2127399
120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
Intervention Type
DRUG
Placebo every 2 weeks
Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose.
Intervention Type
DRUG
Placebo every 4 weeks
Administered via subcutaneous injection for 52 weeks.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of SLE as defined by American College of Rheumatology (ACR) criteria
* Have positive antinuclear antibodies (ANA)
* Agree not to become pregnant throughout the course of the trial
* Have a screening SELENA-SLEDAI score ≥6. (The participant must be actively exhibiting all the symptoms scored on the screening SELENA-SLEDAI on the day of screening.)
* Have positive antinuclear antibodies (ANA)
* Agree not to become pregnant throughout the course of the trial
* Have a screening SELENA-SLEDAI score ≥6. (The participant must be actively exhibiting all the symptoms scored on the screening SELENA-SLEDAI on the day of screening.)
Exclusion Criteria
* Have active severe Lupus kidney disease
* Have active Central Nervous System or peripheral neurologic disease
* Have received intravenous immunoglobulin (IVIg) within 180 days of randomization
* Have active or recent infection within 30 days of screening
* Have had a serious infection within 90 days of randomization
* Have evidence or test positive for Hepatitis B
* Have Hepatitis C
* Are human immunodeficiency virus (HIV) positive
* Have evidence of active or latent tuberculosis (TB)
* Presence of significant laboratory abnormalities at screening
* Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or basal cell or squamous epithelial skin cell that were completely resected with no reoccurrence in the 3 yrs prior to randomization
* Have received greater than 40 mgs of prednisone or equivalent in the past 30 days
* Have changed your dose of antimalarial drug in the past 30 days
* Have changed your dose of immunosuppressive drug in the past 90 days
* Have previously received rituximab
* Have active Central Nervous System or peripheral neurologic disease
* Have received intravenous immunoglobulin (IVIg) within 180 days of randomization
* Have active or recent infection within 30 days of screening
* Have had a serious infection within 90 days of randomization
* Have evidence or test positive for Hepatitis B
* Have Hepatitis C
* Are human immunodeficiency virus (HIV) positive
* Have evidence of active or latent tuberculosis (TB)
* Presence of significant laboratory abnormalities at screening
* Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or basal cell or squamous epithelial skin cell that were completely resected with no reoccurrence in the 3 yrs prior to randomization
* Have received greater than 40 mgs of prednisone or equivalent in the past 30 days
* Have changed your dose of antimalarial drug in the past 30 days
* Have changed your dose of immunosuppressive drug in the past 90 days
* Have previously received rituximab
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Anniston, Alabama, United States
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Birmingham, Alabama, United States
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Gilbert, Arizona, United States
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Malvern, Arkansas, United States
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Covina, California, United States
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Escondido, California, United States
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Atlanta, Georgia, United States
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Duluth, Georgia, United States
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Lithonia, Georgia, United States
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Meridian, Idaho, United States
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Charlotte, North Carolina, United States
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Raleigh, North Carolina, United States
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Rocky Mount, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Duncansville, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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Charleston, South Carolina, United States
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Cookeville, Tennessee, United States
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Knoxville, Tennessee, United States
Site Status
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Memphis, Tennessee, United States
Site Status
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Nashville, Tennessee, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Nassau Bay, Texas, United States
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Round Rock, Texas, United States
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San Antonio, Texas, United States
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Victoria, Texas, United States
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St. George, Utah, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Clarksburg, West Virginia, United States
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St Leonards, New South Wales, Australia
Site Status
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Cairns, Queensland, Australia
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Maroochydore, Queensland, Australia
Site Status
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Clayton, Victoria, Australia
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Heidelberg, Victoria, Australia
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Malvern East, , Australia
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Campinas, , Brazil
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Goiânia, , Brazil
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Juiz de Fora, , Brazil
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Porto Alegre, , Brazil
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Salvador, , Brazil
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São Paulo, , Brazil
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Hamilton, Ontario, Canada
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Trois-Rivières, Quebec, Canada
Site Status
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Cuenca, , Ecuador
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Guayaquil, , Ecuador
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Quito, , Ecuador
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Orléans, , France
Site Status
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Strasbourg, , France
Site Status
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Budapest, , Hungary
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Debrecen, , Hungary
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Győr, , Hungary
Site Status
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Gyula, , Hungary
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Szeged, , Hungary
Site Status
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Bangalore, , India
Site Status
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Gujarat, , India
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Haryāna, , India
Site Status
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Hyderabaad, , India
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Kormangala, , India
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Pune, , India
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Trivandrum, , India
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Haifa, , Israel
Site Status
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Kfar Saba, , Israel
Site Status
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Petah Tikva, , Israel
Site Status
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Tel Litwinsky, , Israel
Site Status
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Ẕerifin, , Israel
Site Status
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Riga, , Latvia
Site Status
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Kota Kinabalu, , Malaysia
Site Status
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Kuala Lumpur, , Malaysia
Site Status
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Guadalajara, , Mexico
Site Status
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Mexico City, , Mexico
Site Status
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Mérida, , Mexico
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San Luis, , Mexico
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San Luis Potosí City, , Mexico
Site Status
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Tijuana, , Mexico
Site Status
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Hamilton, , New Zealand
Site Status
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Otahuhu, , New Zealand
Site Status
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Takapuna, , New Zealand
Site Status
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Brasov, , Romania
Site Status
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Bucharest, , Romania
Site Status
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Cluj-Napoca, , Romania
Site Status
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Galati, , Romania
Site Status
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Iași, , Romania
Site Status
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Târgu Mureş, , Romania
Site Status
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Chelyabinsk, , Russia
Site Status
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Kazan', , Russia
Site Status
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Kemerovo, , Russia
Site Status
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Moscow, , Russia
Site Status
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Orenburg, , Russia
Site Status
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Saint Petersburg, , Russia
Site Status
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Tomsk, , Russia
Site Status
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Yaroslavl, , Russia
Site Status
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Yekaterinburg, , Russia
Site Status
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Belgrade, , Serbia
Site Status
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Kragujevac, , Serbia
Site Status
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Niška Banja, , Serbia
Site Status
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Novi Sad, , Serbia
Site Status
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Cape Town, , South Africa
Site Status
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Durban, , South Africa
Site Status
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Stellenbosch, , South Africa
Site Status
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A Coruña, , Spain
Site Status
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Barcelona, , Spain
Site Status
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Bilbao, , Spain
Site Status
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Las Palmas de Gran Canaria, , Spain
Site Status
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Madrid, , Spain
Site Status
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Málaga, , Spain
Site Status
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Santiago de Compostela, , Spain
Site Status
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Seville, , Spain
Site Status
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Vigo, , Spain
Site Status
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Changhua, , Taiwan
Site Status
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Hualien City, , Taiwan
Site Status
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Kaohsiung City, , Taiwan
Site Status
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Taichung, , Taiwan
Site Status
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Taichung, , Taiwan
Site Status
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Taipei, , Taiwan
Site Status
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La Marsa, , Tunisia
Site Status
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Monastir, , Tunisia
Site Status
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Sfax, , Tunisia
Site Status
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sousse, , Tunisia
Site Status
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tunis, , Tunisia
Site Status
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tunis Monfleury, , Tunisia
Site Status
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cambridge, Cambridgeshire, United Kingdom
Site Status
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Poole, Dorset, United Kingdom
Site Status
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
London, Greater London, United Kingdom
Site Status
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Maidstone, Kent, United Kingdom
Site Status
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Wigan, Lancashire, United Kingdom
Site Status
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
London, , United Kingdom
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
Australia
Brazil
Canada
Ecuador
France
Hungary
India
Israel
Latvia
Malaysia
Mexico
New Zealand
Romania
Russia
Serbia
South Africa
Spain
Taiwan
Tunisia
United Kingdom
References
Explore related publications, articles, or registry entries linked to this study.
Vendel AC, Jaroszewski L, Linnik MD, Godzik A. B- and T-Lymphocyte Attenuator in Systemic Lupus Erythematosus Disease Pathogenesis. Clin Pharmacol Ther. 2024 Jul;116(1):247-256. doi: 10.1002/cpt.3282. Epub 2024 Apr 26.
Reference Type
DERIVED
Toro-Dominguez D, Martorell-Marugan J, Martinez-Bueno M, Lopez-Dominguez R, Carnero-Montoro E, Barturen G, Goldman D, Petri M, Carmona-Saez P, Alarcon-Riquelme ME. Scoring personalized molecular portraits identify Systemic Lupus Erythematosus subtypes and predict individualized drug responses, symptomatology and disease progression. Brief Bioinform. 2022 Sep 20;23(5):bbac332. doi: 10.1093/bib/bbac332.
Reference Type
DERIVED
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Reference Type
DERIVED
Li Y, Higgs RE, Hoffman RW, Dow ER, Liu X, Petri M, Wallace DJ, Dorner T, Eastwood BJ, Miller BB, Liu Y. A Bayesian gene network reveals insight into the JAK-STAT pathway in systemic lupus erythematosus. PLoS One. 2019 Dec 2;14(12):e0225651. doi: 10.1371/journal.pone.0225651. eCollection 2019.
Reference Type
DERIVED
Kalunian KC, Urowitz MB, Isenberg D, Merrill JT, Petri M, Furie RA, Morgan-Cox MA, Taha R, Watts S, Silk M, Linnik MD. Clinical trial parameters that influence outcomes in lupus trials that use the systemic lupus erythematosus responder index. Rheumatology (Oxford). 2018 Jan 1;57(1):125-133. doi: 10.1093/rheumatology/kex368.
Reference Type
DERIVED
Hoffman RW, Merrill JT, Alarcon-Riquelme MM, Petri M, Dow ER, Nantz E, Nisenbaum LK, Schroeder KM, Komocsar WJ, Perumal NB, Linnik MD, Airey DC, Liu Y, Rocha GV, Higgs RE. Gene Expression and Pharmacodynamic Changes in 1,760 Systemic Lupus Erythematosus Patients From Two Phase III Trials of BAFF Blockade With Tabalumab. Arthritis Rheumatol. 2017 Mar;69(3):643-654. doi: 10.1002/art.39950.
Reference Type
DERIVED
Rovin BH, Dooley MA, Radhakrishnan J, Ginzler EM, Forrester TD, Anderson PW. The impact of tabalumab on the kidney in systemic lupus erythematosus: results from two phase 3 randomized, clinical trials. Lupus. 2016 Dec;25(14):1597-1601. doi: 10.1177/0961203316650734. Epub 2016 May 24.
Reference Type
DERIVED
Merrill JT, van Vollenhoven RF, Buyon JP, Furie RA, Stohl W, Morgan-Cox M, Dickson C, Anderson PW, Lee C, Berclaz PY, Dorner T. Efficacy and safety of subcutaneous tabalumab, a monoclonal antibody to B-cell activating factor, in patients with systemic lupus erythematosus: results from ILLUMINATE-2, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2016 Feb;75(2):332-40. doi: 10.1136/annrheumdis-2015-207654. Epub 2015 Aug 20.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H9B-MC-BCDT
Identifier Type: OTHER
Identifier Source: secondary_id
13653
Identifier Type: -
Identifier Source: org_study_id
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