Trial · NCT03616912
A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus
NCT03616912, Phase 3, Terminated, Eli Lilly and Company; results first posted 2023-01-30
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus. Trials, record NCT03616912. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03616912
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus
- NCT number
- NCT03616912
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 830 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Baricitinib, Placebo
- First posted
- 2018-08-06
- Last updated
- 2023-01-30
- Other registries' IDs
- eudract:2017-005026-37
- Results first posted
- 2023-01-30
- Limitations and caveats
One investigational site with seven participants was excluded from analysis due to confirmed misconduct.~Study terminated due to insufficient evidence to support a positive benefit: risk profile in systemic lupus erythematosus patients.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib) | Week 52 | 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). |
| Secondary | Percentage of Participants Achieving SRI-4 Response - 2 mg Baricitinib | Week 52 | 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). |
| Secondary | Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS) | Week 52 | 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. |
| Secondary | Time to First Severe Flare | Baseline to Week 52 | 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. |
| Secondary | 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 | Baseline, Week 40 through Week 52 | 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. |
| Secondary | Change From Baseline in Worst Pain Numeric Rating Scale (NRS) | Baseline, Week 52 | 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. |
| Secondary | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Total Score | Baseline, Week 52 | 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. |
| Secondary | 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 | Week 52 | 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. |
| Secondary | Change From Baseline in Tender Joints Count | Baseline, Week 52 | 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. |
| Secondary | Change From Baseline in Swollen Joint Count | Baseline, Week 52 | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib) | Week 52 | All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (Modified intent to treat (mITT population). Missing data was imputed using the hybrid imputation method \[nonresponder imputation (NRI) + multiple imputation (MI)\]. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving SRI-4 Response - 2 mg Baricitinib | Week 52 | All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population). Missing data was imputed using the hybrid imputation method \[nonresponder imputation (NRI) + multiple imputation (MI)\]. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS) | Week 52 | All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population). Missing data was imputed using the hybrid imputation method \[nonresponder imputation (NRI) + multiple imputation (MI)\]. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | percentage of participants | NUMBER |
| SECONDARY | Time to First Severe Flare | Baseline to Week 52 | All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population). As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | weeks | MEDIAN |
| SECONDARY | 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 | Baseline, Week 40 through Week 52 | All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population) and received \>7.5 mg prednisone at baseline. Missing data was imputed using the hybrid imputation method \[NRI + modified last observation carried forward\]. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Worst Pain Numeric Rating Scale (NRS) | Baseline, Week 52 | All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population) and had baseline and post-baseline values at the specified time point. Missing data was imputed using the hybrid imputation method (NRI + MMRM). As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Total Score | Baseline, Week 52 | All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population) and had baseline and post-baseline values at the specified time-point. Missing data was imputed using the hybrid imputation method (NRI + MMRM). As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | Week 52 | All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population) and had baseline CLASI score of \>= 10. Missing data was imputed using NRI method. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Tender Joints Count | Baseline, Week 52 | All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population) and had baseline and post-baseline values at specified time point. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | tender joint count | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Swollen Joint Count | Baseline, Week 52 | All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population) and had baseline and post-baseline values at the specified time point. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | swollen joint count | LEAST_SQUARES_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib) | Placebo | 45.9 | percentage of participants | ||
| Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib) | 4 mg Baricitinib | 56.7 | percentage of participants | ||
| Percentage of Participants Achieving SRI-4 Response - 2 mg Baricitinib | Placebo | 45.9 | percentage of participants | ||
| Percentage of Participants Achieving SRI-4 Response - 2 mg Baricitinib | 2 mg Baricitinib | 49.8 | percentage of participants | ||
| Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS) | Placebo | 26.2 | percentage of participants | ||
| Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS) | 2 mg Baricitinib | 25.7 | percentage of participants | ||
| Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS) | 4 mg Baricitinib | 29.7 | percentage of participants | ||
| Time to First Severe Flare | Placebo | NA | 95% Confidence Interval NA to NA | weeks | |
| Time to First Severe Flare | 2 mg Baricitinib | NA | 95% Confidence Interval NA to NA | weeks | |
| Time to First Severe Flare | 4 mg Baricitinib | NA | 95% Confidence Interval NA to NA | weeks |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 257 | |
| Overall Study | STARTED | 2 mg Baricitinib | 258 | |
| Overall Study | STARTED | 4 mg Baricitinib | 254 | |
| Overall Study | STARTED | Placebo (MEE) | 21 | |
| Overall Study | STARTED | 2 mg Baricitinib (MEE) | 20 | |
| Overall Study | STARTED | 4 mg Baricitinib (MEE) | 20 | |
| Overall Study | Received at Least One Dose of Study Drug | Placebo | 257 | |
| Overall Study | Received at Least One Dose of Study Drug | 2 mg Baricitinib | 256 | |
| Overall Study | Received at Least One Dose of Study Drug | 4 mg Baricitinib | 254 | |
| Overall Study | Received at Least One Dose of Study Drug | Placebo (MEE) | 21 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events690
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 4 | 253 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | 2 mg Baricitinib | 4 | 255 | 6 |
| other | Anaemia | Blood and lymphatic system disorders | 4 mg Baricitinib | 13 | 252 | 16 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo Maximum Extended Enrollment (MEE) | 3 | 21 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | 2 mg Baricitinib (MEE) | 2 | 20 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | 4 mg Baricitinib (MEE) | 2 | 20 | 2 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Placebo | 0 | 253 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | 2 mg Baricitinib | 4 | 255 | 4 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | 4 mg Baricitinib | 0 | 252 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Placebo Maximum Extended Enrollment (MEE) | 2 | 21 | 2 |
1 to 10 of 690Source ClinicalTrials.gov
See all 690 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 1 | 253 |
| Total, all-cause mortality | 2 mg Baricitinib | 1 | 255 |
| Total, all-cause mortality | 4 mg Baricitinib | 0 | 252 |
| Total, all-cause mortality | Placebo Maximum Extended Enrollment (MEE) | 0 | 21 |
| Total, all-cause mortality | 2 mg Baricitinib (MEE) | 0 | 20 |
| Total, all-cause mortality | 4 mg Baricitinib (MEE) | 0 | 20 |
| Total, other adverse events | Placebo | 129 | 253 |
| Total, other adverse events | 2 mg Baricitinib | 144 | 255 |
| Total, other adverse events | 4 mg Baricitinib | 144 | 252 |
| Total, other adverse events | Placebo Maximum Extended Enrollment (MEE) | 17 | 21 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03616912
GET https://conductscience.org/api/trials/v1/NCT03616912/results?page=2