A Study of Baricitinib in Participants With Systemic Lupus Erythematosus
| Status: | Recruiting | 
|---|---|
| Conditions: | Lupus | 
| Therapuetic Areas: | Immunology / Infectious Diseases | 
| Healthy: | No | 
| Age Range: | 18 - Any | 
| Updated: | 4/5/2019 | 
| Start Date: | August 2, 2018 | 
| End Date: | February 16, 2021 | 
| Contact: | There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 
| Email: | clinicaltrials.gov@lilly.com | 
| Phone: | 1-317-615-4559 | 
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus
The reason for this study is to see how effective and safe the study drug known as
baricitinib is in participants with systemic lupus erythematosus (SLE).
			baricitinib is in participants with systemic lupus erythematosus (SLE).
Inclusion Criteria:
- Have a clinical diagnosis of SLE at least 24 weeks prior to screening.
- Have documentation of having met at least 4 of 11 Revised Criteria for Classification
of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 American
College of Rheumatology (ACR) criteria for classification of SLE prior to
randomization.
- Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive
anti-double-stranded deoxyribonucleic acid (dsDNA), and/or a positive anti-Smith
(anti-Sm) as assessed by a central laboratory during screening.
- Have a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
score ≥6 during screening.
- Have a clinical SLEDAI-2K score ≥4 at randomization.
- Have at least 1 British Isles Lupus Assessment Group (BILAG) A score or 2 BILAG B
scores during screening.
- Are receiving at least one of the following standard of care medications for SLE:
- A single antimalarial at a stable dose for at least 8 weeks prior to screening
- A single immunosuppressant at a stable dose for at least 8 weeks prior to
screening
- An oral corticosteroid, initiated at least 4 weeks prior to screening, at a
stable dose ≤40 milligrams/day prednisone (or equivalent) for at least 2 weeks
prior to screening. If the participant is not receiving an antimalarial or
immunosuppressant, the dose of corticosteroid must be ≥7.5 milligrams/day
prednisone (or equivalent)
Exclusion Criteria:
- Have severe active lupus nephritis.
- Have active central nervous system (CNS) lupus.
- Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal,
endocrine, hematological, neurological, or neuropsychiatric disorders or any other
serious and/or unstable illness that, in the opinion of the investigator, could
constitute an unacceptable risk when taking investigational product or interfere with
the interpretation of data.
- Have a current or recent clinically serious viral, bacterial, fungal, or parasitic
infection.
- Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to
screening.
We found this trial at
    32
    sites
	
								Plantation, Florida 33324			
	
			
					Principal Investigator: Guillermo Valenzuela
			
						
										Phone: 909-580-6320
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									201 Dowman Dr
Atlanta, Georgia 30303
	
			Atlanta, Georgia 30303
(404) 727-6123
							 
					Principal Investigator: Arezou Khosroshahi
			
						
										Phone: 404-778-6638
					
		Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...  
  
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									2147 Northeast Coachman Road
Clearwater, Florida 33765
	
			
					Clearwater, Florida 33765
Principal Investigator: Robert W Levin
			
						
										Phone: 727-466-0078
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								Albuquerque, New Mexico 			
	
			
					Principal Investigator: Ellen Kim
			
						
										Phone: 505-224-7407
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								Arlington, Virginia 22205			
	
			
					Principal Investigator: Philip Kempf
			
						
										Phone: 70352530698
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									1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
	
			Atlanta, Georgia 30342
(404) 851-8000
							 
					Principal Investigator: Paul Geo Sutej
			
						
								
		Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...  
  
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									8750 Wilshire Boulevard
Beverly Hills, California 90211
	
			
					Beverly Hills, California 90211
Principal Investigator: Daniel Jeffrey Wallace
			
						
										Phone: 13103609197
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								Caba, Buenos Aires 			
	
			
					Principal Investigator: Pablo Mannucci
			
						
										Phone: 541149512763
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								Charlotte, North Carolina 00000			
	
			
					Principal Investigator: Emily Jane Box
			
						
										Phone: 704-247-9179
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								Charlotte, North Carolina 28204			
	
			
					Principal Investigator: Alireza Nami
			
						
										Phone: 704-248-8577
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								Cincinnati, Ohio 45242			
	
			
					Principal Investigator: Michael Luggen
			
						
										Phone: 513-558-5538
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								Covina, California 91723			
	
			
					Principal Investigator: Samy K Metyas
			
						
										Phone: 562-713-2596
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								Dallas, Texas 75231			
	
			
					Principal Investigator: Margarita Fallena
			
						
										Phone: 214-879-6737
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								Danville, Virginia 24541			
	
			
					Principal Investigator: Sharukh D Shroff
			
						
										Phone: 4347934711349
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								Gilbert, Arizona 85704			
	
			
					Principal Investigator: Daniel E Kreutz
			
						
										Phone: 480-626-6650
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									9500 Gilman Dr
La Jolla, California 92093
	
			La Jolla, California 92093
(858) 534-2230
							 
					Principal Investigator: Susan Lee
			
						
										Phone: 858-657-7040
					
		The University of California, San Diego UC San Diego is an academic powerhouse and economic...  
  
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									1255 Hillrise Circle
Las Cruces, New Mexico 88011
	
			
					Las Cruces, New Mexico 88011
Principal Investigator: Arthur R Snyder
			
						
										Phone: 575-571-7529
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								Las Vegas, Nevada 89128			
	
			
					Principal Investigator: George Timothy Kelly
			
						
										Phone: 7023415444
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									500 Medical Center Boulevard
Lawrenceville, Georgia 30046
	
			
					Lawrenceville, Georgia 30046
Principal Investigator: Theresa A Ford
			
						
										Phone: 770-822-1090
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								Lexington, Kentucky 40504			
	
			
					Principal Investigator: Alexander D Brown
			
						
										Phone: 859-351-5175
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								Norman, Oklahoma 73069			
	
			
					Principal Investigator: Robert L McArthur
			
						
										Phone: 405-552-9492
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								Ormond Beach, Florida 32174			
	
			
					Principal Investigator: Michael David Kohen
			
						
										Phone: 3866721985
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								Phoenix, Arizona 85037			
	
			
					Principal Investigator: Eric A Peters
			
						
										Phone: 480-626-6656
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									750 East Adams Street
Syracuse, New York 13210
	
			
					Syracuse, New York 13210
Principal Investigator: Andras Perl
			
						
										Phone: 315-464-4194
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									5115 North Armenia Avenue
Tampa, Florida 33603
	
			
					Tampa, Florida 33603
Principal Investigator: Edgard Janer
			
						
										Phone: 813-870-1292
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								Tampa, Florida 33614			
	
			
					Principal Investigator: Michael C Burnette
			
						
										Phone: 813-840-3600
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									7520 North Oracle Road
Tucson, Arizona 85704
	
			
					Tucson, Arizona 85704
Principal Investigator: Jeffrey B Loomer
			
						
										Phone: 480-443-8400
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								Tupelo, Mississippi 38801			
	
			
					Principal Investigator: Charles King
			
						
										Phone: 662-377-5131
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								Tustin, California 92780			
	
			
					Principal Investigator: Robin K Dore
			
						
										Phone: 714-505-5500
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								Upland, California 91786			
	
			
					Principal Investigator: Antony Hou
			
						
										Phone: 909-296-8700
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								Webster, Texas 77598			
	
			
					Principal Investigator: Abdelnaser Naser Elkhalili
			
						
										Phone: 2817241860
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								Wyomissing, Pennsylvania 19610			
	
			
					Principal Investigator: Nancy J Walker
			
						
										Phone: 610-375-2466
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