A Phase 3 interventional study of Baricitinib and Placebo in Systemic Lupus Erythematosus, sponsored by Eli Lilly and Company. Completed at 159 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-23.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
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).
1,222 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's enrollment of 778 is above the median of 50 across 881 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.
Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Are receiving at least one of the following standard of care medications for SLE:
Exclusion Criteria:
Participants received one 2 mg baricitinib tablet and one placebo tablet matching 4 mg baricitinib administered orally once daily (QD) for 52 weeks.
Drug: Baricitinib · Drug: Placebo
Participants received one 4 mg baricitinib tablet and one placebo tablet matching 2 mg baricitinib administered orally QD for 52 weeks.
Drug: Baricitinib · Drug: Placebo
Participants received 2 placebo tablets: one placebo tablet matching 4 mg baricitinib and one placebo tablet matching 2 mg baricitinib administered orally QD for 52 weeks.
Drug: Placebo
Administered orally.
Also known as: LY3009104
Administered orally
Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib)
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).
Time frame: Week 52
Percentage of Participants Achieving SRI-4 Response (2 mg Baricitinib)
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).
Time frame: Week 52
Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)
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.
Time frame: Week 52
Time to First Severe Flare
Time to first severe flare 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.
Time frame: Baseline to Week 52
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
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.
Time frame: Baseline, Week 40 through Week 52
Change From Baseline in Worst Pain Numeric Rating Scale (NRS)
Participants assessed the 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.
Time frame: Baseline, Week 52
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Total Score
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.
Time frame: Baseline, Week 52
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
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.
Time frame: Week 52
Change From Baseline in Tender Joint Count
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.
Time frame: Baseline, Week 52
Change From Baseline in Swollen Joint Count
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.
Time frame: Baseline, Week 52
Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve for Dosing Interval of Baricitinib at Steady State (AUCtau,ss)
AUCtau,ss reported for participants who received multiple doses of mg baricitinib was derived by a population pharmacokinetics approach.
Time frame: 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
Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss)
PK: Maximum Concentration of Baricitinib at steady-state (Cmax,ss) was derived by a population pharmacokinetics approach.
Time frame: 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
| Milestone | Placebo | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|
| Started | 257 | 262 | 259 |
| Received at least one dose of study drug | 256 | 261 | 258 |
| Safety population | 256 | 261 | 258 |
| Pharmacokinetic (pk) population | 0 | 277 | 241 |
| Completed | 212 | 222 | 205 |
| Not completed | 45 | 40 | 54 |
| Withdrew: Adverse event | 15 | 10 | 16 |
| Withdrew: Death | 3 | 0 | 4 |
| Withdrew: Lack of efficacy | 4 | 8 | 8 |
| Withdrew: Lost to follow-up | 2 | 1 | 3 |
| Withdrew: Withdrawal by subject | 18 | 14 | 21 |
| Withdrew: Withdrawal by principal investigator (pi) | 1 | 1 | 1 |
| Withdrew: Sponsor's decision | 1 | 0 | 0 |
| Withdrew: Physician decision | 0 | 2 | 0 |
| Withdrew: Decreased neutrophils due to systemic lupus erythematosus (sle) | 0 | 1 | 0 |
| Withdrew: Protocol violation | 0 | 1 | 0 |
| Withdrew: Due to epidemic/pandemic | 0 | 1 | 0 |
| Withdrew: Randomized but never treated | 1 | 1 | 1 |
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).
| percentage of participants | Placebo | 4 mg Baricitinib |
|---|---|---|
| Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib) | 45.6 | 47.1 |
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).
| percentage of participants | Placebo | 2 mg Baricitinib |
|---|---|---|
| Percentage of Participants Achieving SRI-4 Response (2 mg Baricitinib) | 45.6 | 46.3 |
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.
| percentage of participants | Placebo | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|
| Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS) | 23.2 | 24.0 | 25.4 |
Time to first severe flare 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.
| weeks | Placebo | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|
| Time to First Severe Flare | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
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.
| percentage of participants | Placebo | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|
| 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 | 31.7 | 29.8 | 34.3 |
Participants assessed the 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.
| score on a scale | Placebo | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|
| Change From Baseline in Worst Pain Numeric Rating Scale (NRS) | -1.37 ± 0.14 | -1.45 ± 0.14 | -1.44 ± 0.14 |
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.
| score on a scale | Placebo | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|
| Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Total Score | 7.26 ± 0.60 | 6.90 ± 0.60 | 6.96 ± 0.61 |
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.
| percentage of participants | Placebo | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|
| 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 | 66.1 | 56.9 | 58.0 |
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.
| tender joint count | Placebo | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|
| Change From Baseline in Tender Joint Count | -6.92 ± 0.301 | -7.40 ± 0.300 | -7.83 ± 0.306 |
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.
| swollen joint count | Placebo | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|
| Change From Baseline in Swollen Joint Count | -4.79 ± 0.202 | -5.10 ± 0.201 | -5.31 ± 0.205 |
AUCtau,ss reported for participants who received multiple doses of mg baricitinib was derived by a population pharmacokinetics approach.
| nanogram*hour/milliliter (ng*h/mL) | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|
| Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve for Dosing Interval of Baricitinib at Steady State (AUCtau,ss) | 257 ± 48 | 505 ± 50 |
PK: Maximum Concentration of Baricitinib at steady-state (Cmax,ss) was derived by a population pharmacokinetics approach.
| nanograms per milliliter (ng/mL) | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|
| Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) | 27.0 ± 23 | 54.1 ± 24 |
Collected over Baseline through Follow-up (Up to 56 Weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 3/256 (1.2%) | 26/256 (10.2%) | 96/256 (37.5%) |
| 2 mg Baricitinib | 0/261 (0%) | 35/261 (13.4%) | 100/261 (38.3%) |
| 4 mg Baricitinib | 4/258 (1.6%) | 32/258 (12.4%) | 96/258 (37.2%) |
| Event | Placebo | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|
| Systemic lupus erythematosusMusculoskeletal and connective tissue disorders | 0/256 | 6/261 | 3/258 |
| PneumoniaInfections and infestations | 3/256 | 1/261 | 2/258 |
| Pneumonia bacterialInfections and infestations | 2/256 | 0/261 | 1/258 |
| Deep vein thrombosisVascular disorders | 2/256 | 0/261 | 0/258 |
| PancytopeniaBlood and lymphatic system disorders | 0/256 | 0/261 | 2/258 |
| CholelithiasisHepatobiliary disorders | 1/256 | 0/261 | 2/258 |
| Covid-19Infections and infestations | 1/256 | 2/261 | 1/258 |
| Hip arthroplastySurgical and medical procedures | 0/256 | 2/261 | 0/258 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 1/241 | 1/246 | 1/245 |
| Postmenopausal haemorrhageReproductive system and breast disorders | 1/241 | 0/246 | 0/245 |
| Event | Placebo | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|
| Urinary tract infectionInfections and infestations | 26/256 | 29/261 | 19/258 |
| HeadacheNervous system disorders | 23/256 | 25/261 | 19/258 |
| NasopharyngitisInfections and infestations | 23/256 | 18/261 | 21/258 |
| DiarrhoeaGastrointestinal disorders | 13/256 | 20/261 | 10/258 |
| Upper respiratory tract infectionInfections and infestations | 13/256 | 17/261 | 19/258 |
| Back painMusculoskeletal and connective tissue disorders | 6/256 | 8/261 | 15/258 |
| NeutropeniaBlood and lymphatic system disorders | 7/256 | 5/261 | 13/258 |
| HypertensionVascular disorders | 9/256 | 12/261 | 13/258 |
All randomized participants who received at least one dose of study drug.
| Age, Continuous(years) | Placebo | 2 mg Baricitinib | 4 mg Baricitinib | Total |
|---|---|---|---|---|
| Mean | 43.50 ± 13.47 | 42.80 ± 12.99 | 42.20 ± 12.11 | 42.80 ± 12.86 |
| Sex: Female, Male(Participants) | Placebo | 2 mg Baricitinib | 4 mg Baricitinib | Total |
|---|---|---|---|---|
| Female | 241 | 246 | 245 | 732 |
| Male | 15 | 15 | 13 | 43 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | 2 mg Baricitinib | 4 mg Baricitinib | Total |
|---|---|---|---|---|
| Hispanic or Latino | 9 | 11 | 8 | 28 |
| Not Hispanic or Latino | 40 | 38 | 40 | 118 |
| Unknown or Not Reported | 207 | 212 | 210 | 629 |
| Race (NIH/OMB)(Participants) | Placebo | 2 mg Baricitinib | 4 mg Baricitinib | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 14 | 12 | 13 | 39 |
| Asian | 71 | 66 | 70 | 207 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 1 |
| Black or African American | 17 | 23 | 26 | 66 |
| White | 145 | 152 | 140 | 437 |
| More than one race | 5 | 4 | 4 | 13 |
| Unknown or Not Reported | 4 | 4 | 4 | 12 |
| Region of Enrollment(Participants) | Placebo | 2 mg Baricitinib | 4 mg Baricitinib | Total |
|---|---|---|---|---|
| Argentina | 34 | 29 | 29 | 92 |
| Chile | 8 | 14 | 12 | 34 |
| Colombia | 17 | 15 | 16 | 48 |
| France | 3 | 2 | 2 | 7 |
| India | 32 | 28 | 34 | 94 |
| Italy | 2 | 2 | 5 | 9 |
| Japan | 14 | 12 | 12 | 38 |
| Philippines | 13 | 14 | 11 | 38 |
| Poland | 26 | 36 | 31 | 93 |
| Romania | 12 | 11 | 7 | 30 |
| Serbia | 15 | 20 | 18 | 53 |
| South Africa | 14 | 15 | 12 | 41 |
| South Korea | 4 | 7 | 8 | 19 |
| Spain | 12 | 6 | 12 | 30 |
| United States | 50 | 50 | 49 | 149 |
Showing the first 100 of 159 sites across 15 countries.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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 information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: 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.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · vivli.org
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Studies of the drug tested here: Baricitinib
Lupus Erythematosus, Systemic →