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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03616912
Registration number
NCT03616912
Ethics application status
Date submitted
1/08/2018
Date registered
6/08/2018
Titles & IDs
Public title
A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus
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Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus
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Secondary ID [1]
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I4V-MC-JAHZ
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Secondary ID [2]
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16676
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Universal Trial Number (UTN)
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Trial acronym
SLE-BRAVE I
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Baricitinib
Treatment: Drugs - Placebo
Placebo comparator: Placebo - Participants received two placebo tablets: one matching baricitinib 4 milligram (mg) and one matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.
Experimental: 2 mg Baricitinib - Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
Experimental: 4 mg Baricitinib - Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.
Placebo comparator: Placebo Maximum Extended Enrollment (MEE) - Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
Experimental: 2 mg Baricitinib (MEE) - Participants received one Baricitinib 2 mg tablet and 1 placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
Experimental: 4 mg Baricitinib (MEE) - Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.
Treatment: Drugs: Baricitinib
Administered orally.
Treatment: Drugs: Placebo
Administered orally.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib)
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Assessment method [1]
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SRI-4 response defined as 1)greater than or equal to (\>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score 2)no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and 3)no worsening in Physician Global Assessment (PGA) of Disease Activity (worsening defined as an increase of \>=0.3 from baseline on a 0-3 visual analogue scale).
SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms,or laboratory parameters related to Systemic Lupus Erythematosus (SLE),divided into 9 organ systems. For each organ system A=severe disease,B=moderate disease,C=mild stable disease,D=inactive,but previously active,E=inactive and never affected. PGA assess disease activity on a visual analogue scale from 0 to 3 (1=mild, 2=moderate, 3=severe).
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Timepoint [1]
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Week 52
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Secondary outcome [1]
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Percentage of Participants Achieving SRI-4 Response - 2 mg Baricitinib
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Assessment method [1]
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SRI-4 response defined as 1)greater than or equal to (\>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score 2)no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and 3)no worsening in Physician Global Assessment (PGA) of Disease Activity (worsening defined as an increase of \>=0.3 from baseline on a 0-3 visual analogue scale).
SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms,or laboratory parameters related to Systemic Lupus Erythematosus (SLE),divided into 9 organ systems. For each organ system A=severe disease,B=moderate disease,C=mild stable disease,D=inactive,but previously active,E=inactive and never affected. PGA assess disease activity on a visual analogue scale from 0 to 3 (1=mild, 2=moderate, 3=severe).
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Timepoint [1]
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Week 52
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Secondary outcome [2]
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Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)
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Assessment method [2]
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The LLDAS is a composite measure designed to identify patients achieving a state of low disease activity. The LLDAS response criteria were: (1) SLEDAI-2K \<=4, with no activity in major organ systems (CNS, vascular, renal, cardiorespiratory and constitutional); where "no activity" is defined as all items of SLEDAI-2K within these major organ systems equal to 0. (2) no new features of lupus disease activity compared to previous occurred visit, where the "new feature" is defined as any of the SLEDAI-2K 24 items changed from 0 to greater than 0; (3) PGA (scale 0-3), \<=1; (4) current prednisolone (or equivalent) dose \<=7.5 mg daily.
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Timepoint [2]
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Week 52
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Secondary outcome [3]
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Time to First Severe Flare
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Assessment method [3]
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Time to first severe flare was analyzed using a Cox proportional hazards model with treatment group, baseline disease activity (Systemic Lupus Erythematosus Disease Activity Index 2000 \[SLEDAI-2K \] \<10; SLEDAI-2K =10), baseline corticosteroid dose (\<10 mg/day; =10 mg/day prednisone or equivalent), and region fitted as explanatory variables. Participants who did not have severe flare during the flare exposure time period were censored at the end of the flare exposure time.
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Timepoint [3]
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Baseline to Week 52
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Secondary outcome [4]
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Percentage of Participants Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Participants Receiving Greater Than 7.5 mg/Day at Baseline
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Assessment method [4]
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For the analysis of steroid use, steroid dosages were converted to a prednisone equivalent in mg. A responder was defined as having a prednisone reduction by \>=25% from Baseline to \<=7.5 mg/day during Weeks 40 through 52.
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Timepoint [4]
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Baseline, Week 40 through Week 52
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Secondary outcome [5]
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Change From Baseline in Worst Pain Numeric Rating Scale (NRS)
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Assessment method [5]
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Participants assessed their worst pain in the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The average worst daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. Higher score indicated severe pain. Least Squares (LS) mean was calculated using Mixed Model Repeated Measures (MMRM) analysis with treatment, baseline disease activity (total SLEDAI-2K \<10; \>=10), baseline corticosteroid dose (\<10 mg/day; \>= 10 mg/day prednisone or equivalent), region (North America, Central/South, America/Mexico, Europe, Asia Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.
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Timepoint [5]
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Baseline, Week 52
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Secondary outcome [6]
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Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Total Score
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Assessment method [6]
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FACIT-Fatigue score calculated according to a 13-item questionnaire that assess self reported fatigue and its impact upon daily activities and function. It uses a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse possible score) to 52 (best score). A higher score reflected an improvement in the participant's health status. Least Squares (LS) mean was calculated using Mixed Model Repeated Measures (MMRM) analysis with treatment, baseline disease activity (total SLEDAI-2K \<10; \>=10), baseline corticosteroid dose (\<10 mg/day; \>= 10 mg/day prednisone or equivalent), region (North America, Central/South, America/Mexico, Europe, Asia Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.
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Timepoint [6]
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Baseline, Week 52
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Secondary outcome [7]
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Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Total Activity Score =10 at Baseline With =50% Reduction in CLASI Total Activity Score
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Assessment method [7]
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The CLASI is a single-page tool that separately quantifies disease activity and damage. For the activity score, points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. The total score represents the sum of the individual scores and ranges from 0 to 70. Higher scores are awarded for more severe manifestations.
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Timepoint [7]
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Week 52
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Secondary outcome [8]
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Change From Baseline in Tender Joints Count
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Assessment method [8]
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The number of tender and painful joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as tender or not tender. LS mean was calculated using Mixed Model Repeated Measures (MMRM) analysis with treatment, baseline disease activity (total SLEDAI-2K \<10; \>=10), baseline corticosteroid dose (\<10 mg/day; \>=10 mg/day prednisone or equivalent), region (North America, Central/South America/Mexico, Europe, Asia and Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.
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Timepoint [8]
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Baseline, Week 52
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Secondary outcome [9]
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Change From Baseline in Swollen Joint Count
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Assessment method [9]
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The number of swollen joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as swollen or not swollen. LS mean was calculated using MMRM analysis with treatment, baseline disease activity (total SLEDAI-2K \<10; \>=10), baseline corticosteroid dose (\<10 mg/day; \>=10 mg/day prednisone or equivalent), region (North America, Central/South America/Mexico, Europe, Asia and Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.
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Timepoint [9]
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Baseline, Week 52
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Secondary outcome [10]
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Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCt, ss)
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Assessment method [10]
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PK: Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCt, ss) was evaluated using population PK approach.
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Timepoint [10]
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Week 0 (Baseline): 15 minutes (min) and 60 min postdose; Week 4: 2 to 4 hours (hr) postdose; Week 8: 4 to 6 hr postdose; Week 12 and Week 16 predose
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Secondary outcome [11]
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Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss)
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Assessment method [11]
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Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) was evaluated using population PK approach.
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Timepoint [11]
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Week 0 (Baseline): 15 minutes (min) and 60 min postdose; Week 4: 2 to 4 hours (hr) postdose; Week 8: 4 to 6 hr postdose; Week 12 and Week 16 predose
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Eligibility
Key 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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/08/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/03/2022
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Sample size
Target
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Accrual to date
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Final
830
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Emeritus Research - Botany
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Recruitment hospital [2]
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The Rheumatology Research Unit Sunshine Coast - Maroochydore
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Emeritus Research - Camberwell
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Monash Medical Centre - Clayton
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St Vincents Hospital Melbourne - Fitzroy
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Recruitment hospital [6]
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Griffith University - Southport
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Recruitment postcode(s) [1]
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2019 - Botany
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Recruitment postcode(s) [2]
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4558 - Maroochydore
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Recruitment postcode(s) [3]
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3124 - Camberwell
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Recruitment postcode(s) [4]
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3168 - Clayton
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Recruitment postcode(s) [5]
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3065 - Fitzroy
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Recruitment postcode(s) [6]
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4215 - Southport
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Recruitment outside Australia
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Germany
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Attiki
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Greece
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Crete
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Larissa
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Greece
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Thessaloniki
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Hungary
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Bekes
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Veszprém City
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Budapest
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Debrecen
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Hungary
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Pecs
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Hungary
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Szeged
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Hungary
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Székesfehérvár
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Israel
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Kfar Saba
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Israel
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Ramat Gan
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Israel
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?eifa
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Mexico
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DF
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Distrito Federal
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Mexico
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Jalisco
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Mexico
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Mexico
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Mexico
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Ciudad De México
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Mexico
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San Luis Potosi
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Netherlands
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Netherlands
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Amsterdam
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Russian Federation
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Saint Petersburg
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Russian Federation
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Chelyabinsk
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Russian Federation
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Kazan
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Russian Federation
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Kursk
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Omsk
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Russian Federation
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Orenburg
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Russian Federation
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Ryazan
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Russian Federation
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Smolensk
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Russian Federation
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Ufa
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Switzerland
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Basel Stadt
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Switzerland
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Sankt Gallen
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Taoyuan Hsien
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Dalin Township
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Taiwan
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Kaohsiung City
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan City
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Taiwan
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Taipei
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United Kingdom
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Kent
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United Kingdom
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Surrey
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United Kingdom
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Doncaster
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Eli Lilly and Company
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Commercial sector/industry
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Incyte Corporation
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Ethics approval
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Summary
Brief summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT03616912
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
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Eli Lilly and Company
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
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Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://trials.lillytrialguide.com/en-US/trial/64a5deI4M0sSScwYIMISsIDescriptionAStudyofBaricitinib(LY3009104)inParticipantsWithSystemicLupusErythematosus
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/12/NCT03616912/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/12/NCT03616912/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03616912