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| ID | Type | Description | Link |
|---|---|---|---|
| I4V-MC-JAIA | Other Identifier | Eli Lilly and Company | |
| 2017-005027-25 | EudraCT Number |
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| Name | Class |
|---|---|
| Incyte Corporation | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 milligram (mg) Baricitinib | Experimental | Participants received one 2 mg baricitinib tablet and one placebo tablet matching 4 mg baricitinib administered orally once daily (QD) for 52 weeks. |
|
| 4 mg Baricitinib | Experimental | Participants received one 4 mg baricitinib tablet and one placebo tablet matching 2 mg baricitinib administered orally QD for 52 weeks. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Arthritis Center | Gilbert | Arizona | 85297 | United States | ||
| Arizona Arthritis & Rheumatology Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40305472 | Derived | Yin J, Hou Y, Wang C, Qin C. Clinical outcomes of baricitinib in patients with systemic lupus erythematosus: Pooled analysis of SLE-BRAVE-I and SLE-BRAVE-II trials. PLoS One. 2025 Apr 30;20(4):e0320179. doi: 10.1371/journal.pone.0320179. eCollection 2025. | |
| 36848919 | Derived | Petri M, Bruce IN, Dorner T, Tanaka Y, Morand EF, Kalunian KC, Cardiel MH, Silk ME, Dickson CL, Meszaros G, Zhang L, Jia B, Zhao Y, McVeigh CJ, Mosca M. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-II). Lancet. 2023 Mar 25;401(10381):1011-1019. doi: 10.1016/S0140-6736(22)02546-6. Epub 2023 Feb 24. |
| Label | URL |
|---|---|
| A Study of Baricitinib in Participants With Systemic Lupus Erythematosus | View source |
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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.
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.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received 2 placebo tablets: one placebo tablet matching 4 milligram (mg) baricitinib and one placebo tablet matching 2 mg baricitinib administered orally once daily (QD) for 52 weeks. |
| FG001 | 2 mg Baricitinib |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 20, 2020 | Jun 24, 2022 |
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| Placebo | Drug | Administered orally |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 |
| Phoenix |
| Arizona |
| 85302 |
| United States |
| Arizona Arthritis & Rheumatology Associates, P. C. | Tucson | Arizona | 85704 | United States |
| Wallace Rheumatic Studies Center | Beverly Hills | California | 90211 | United States |
| Medvin Clinical Research - Weidmann | Covina | California | 91722 | United States |
| Office: Dr Robin K Dore | Tustin | California | 92780 | United States |
| Inland Rheumatology & Osteoporosis Medical Group | Upland | California | 91786 | United States |
| Denver Arthritis Clinic - Lowry | Denver | Colorado | 80230 | United States |
| Clinical Research of West Florida, Inc. (Clearwater) | Clearwater | Florida | 33765 | United States |
| Millennium Research | Ormond Beach | Florida | 32174 | United States |
| Integral Rheumatology & Immunology Specialists | Plantation | Florida | 33324 | United States |
| Clinical Research of West Florida | Tampa | Florida | 33603 | United States |
| Tampa Medical Group, P.A. | Tampa | Florida | 33614 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Northside Hospital | Atlanta | Georgia | 30342 | United States |
| North Georgia Rheumatology, PC | Lawrenceville | Georgia | 30046 | United States |
| Arthritis Center of Lexington | Lexington | Kentucky | 40504 | United States |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21224-6801 | United States |
| Advanced Rheumatology, PC | Lansing | Michigan | 48910 | United States |
| Glacier View Research Institute - Endocrinology | Kalispell | Montana | 59901 | United States |
| Innovative Health Research | Las Vegas | Nevada | 89128 | United States |
| Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico | 87102 | United States |
| Arthritis and Osteoporosis Associates of New Mexico | Las Cruces | New Mexico | 88011 | United States |
| St. Lawrence Health System | Canton | New York | 13617 | United States |
| New York University Medical Center | New York | New York | 10016 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Joint and Muscle Medical Care | Charlotte | North Carolina | 28204 | United States |
| Box Arthritis & Rheumatology of the Carolinas, PLLC | Charlotte | North Carolina | 28210 | United States |
| Cincinnati Rheumatic Disease Study Group | Cincinnati | Ohio | 45242 | United States |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 | United States |
| Clinical Research Center of Reading,LLC | Wyomissing | Pennsylvania | 19610 | United States |
| Articularis Healthcare d/b/a/ Low Country Rheumatology, PA | Summerville | South Carolina | 29486 | United States |
| Eagle Medical | Crossville | Tennessee | 38555 | United States |
| Dr. Dhiman Basu Private Practice | Colleyville | Texas | 76034 | United States |
| Metroplex Clinical Research Center | Dallas | Texas | 75231 | United States |
| Advanced Rheumatology of Houston | The Woodlands | Texas | 77382 | United States |
| Clear Lake Specialties | Webster | Texas | 77598 | United States |
| Arthritis Clinic of Northern VA, P.C. | Arlington | Virginia | 22205 | United States |
| Spectrum Medical Inc. | Danville | Virginia | 24541 | United States |
| Aprillus Asistencia e Investigacion - Servicio de neurologia | CABA | Buenos Aires | C1046AAQ | Argentina |
| DOM Centro de Reumatologia | Ciudad de Buenos Aires | Buenos Aires | C1111AAH | Argentina |
| Framingham Centro Medico | La Plata | Buenos Aires | B1902COS | Argentina |
| CER Instituto Medico | Quilmes | Buenos Aires | B1878DVC | Argentina |
| Instituto de Investigaciones Clinicas Quilmes | Quilmes | Buenos Aires | B1878GEG | Argentina |
| Comite de Etica en Investigacion - CEMIC | Buenos Aires | Ciudad Autonoma de Buenos Aire | C1431FWO | Argentina |
| Clinica Adventista Belgrano | CABA | Ciudad Autónoma de Buenos Aire | C1430EGF | Argentina |
| Sanatorio Británico | Rosario | Santa Fe Province | 2000 | Argentina |
| Centro Medico Privado de Reumatologia | SAN M. de Tucuman | Tucumán Province | T4000AXL | Argentina |
| Sanatorio Guemes Cardiocirugia | Ciudad Autonoma Buenos Aires | C1181AAX | Argentina |
| IR Medical Center S.A. Instituto de Reumatologia | Mendoza | M5500CPH | Argentina |
| Clinical Research Chile SpA | Valdivia | Los Ríos Region | 5110683 | Chile |
| Enroll SpA | Providencia | Región Metropolitana de Santia | 7500587 | Chile |
| Clinica Alemana de Osorno | Osorno | 5290000 | Chile |
| Sociedad Medica Del Aparato Locomotor SA | Santiago | 7510186 | Chile |
| Prosalud y cia. Ltda. | Santiago | Chile |
| ReumaCen Centro Reumatologico Integral | Viña del Mar | 2570017 | Chile |
| HPTU-El Hospital con alma Pablo Tobon Uribe | Medellín | Antioquia | Colombia |
| Circaribe SAS | Barranquilla | Atlántico | Colombia |
| Clinica de la Costa | Barranquilla | Atlántico | Colombia |
| Idearg S.A.S. | Bogota | Cundinamarca | Colombia |
| Centro Integral de Reumatologia e Inmunologia | Bogotá | Cundinamarca | Colombia |
| Servimed S.A.S. | Bucaramanga | Santander Department | 12345 | Colombia |
| Centro de Medicina Interna | Cali | Valle del Cauca Department | Colombia |
| Preventive Care Ltdac | Chía | Colombia |
| CHRU Brest - Hopital Cavale Blanche | Brest | Finistère | 29609 | France |
| Centre hospitalier universitaire de Haut Leveque | Pessac | Gironde | 33604 | France |
| CHU Montpellier Lapeyronie Hospital | Montpellier | Hérault | 34295 | France |
| Centre hospitalier universitaire Pellegrin | Bordeaux | 33076 | France |
| Hopital Européen | Marseille | 13003 | France |
| Krishna Institute of Medical Science | Hyderabad | Andhra Pradesh | 500003 | India |
| Panchshil Hospital | Ahmedabad | Gujarat | 380005 | India |
| CIMS Hospital Private Limited | Ahmedabad | Gujarat | 380060 | India |
| NHL Municipal Medical College & VS General Hospital | Ahmedabad | Gujarat | 38006 | India |
| Shree Giriraj Hospital | Rajkot | Gujarat | 360004 | India |
| Nirmal Hospital Private Limited | Surat | Gujarat | 395002 | India |
| Sterling Hospital | Vadodara | Gujarat | 390007 | India |
| St. John Medical College & Hospital | Bangalore | Karnataka | 560034 | India |
| ChanRe Rheumatology And Immunology Center And Research | Bangalore | Karnataka | 560079 | India |
| Sushruta Multispecialty Hospital & Research Center Pvt Ltd | Hubli | Karnataka | 580021 | India |
| Kasturba Medical College Hospital, Mangalore | Madhav Nagar, Manipal | Karnataka | 576104 | India |
| Jasleen Hospital | Nagpur | Maharashtra | 44012 | India |
| Synexus Affiliate - Sujata Birla Hospital & Medical Research Center | Nashik | Maharashtra | 422101 | India |
| Fortis Escorts Hospital | Jaipur | Rajasthan | 302017 | India |
| Azienda Ospedaliera Universitaria | Modena | MO | 41124 | Italy |
| Azienda Ospedaliera Universitaria Pisana | Pisa | Tuscany | 56100 | Italy |
| IRCCS Ospedale Policlinico San Martino | Genova | 16132 | Italy |
| Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| Azienda Policlinico Umberto I | Roma | 00161 | Italy |
| Azienda Ospedaliera Santa Maria Della Misericordia | Udine | 33100 | Italy |
| University of Occupational and Enviromental Health | Kitakyushu | Fukuoka | 807-8556 | Japan |
| Hiroshima University Hospital | Hiroshima | Hiroshima | 734-8551 | Japan |
| National Hospital Organization Asahikawa Medical Center | Asahikawa | Hokkaido | 070-8644 | Japan |
| Hokkaido University Hospital | Sapporo | Hokkaido | 060-8648 | Japan |
| Jp Red Cross Society Himeji Hp | Himeji | Hyōgo | 670-8540 | Japan |
| Kobe University Hospital | Kobe | Hyōgo | 650-0017 | Japan |
| Kagawa University Hospital | Kita-gun | Kagawa-ken | 761-0793 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| Juntendo University Hospital | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| St. Lukes International Hospital | Chuo-Ku | Tokyo | 104 8560 | Japan |
| Toho University Ohashi Med C | Meguro-ku | Tokyo | 153-8515 | Japan |
| Showa University Hospital | Shinagawa-ku | Tokyo | 142-8666 | Japan |
| Keio University Hospital | Shinjuku-Ku | Tokyo | 160-8582 | Japan |
| National Hospital Organization Kyushu Medical Center | Fukuoka | 810 8563 | Japan |
| Hamanomachi Hospital | Fukuoka | 810-8539 | Japan |
| Nippon Medical School Hospital | Tokyo | 113-8603 | Japan |
| Mary Mediatrix Medical Center | Lipa | Batangas | 4217 | Philippines |
| Cebu Doctors Hospital | Cebu City | Cebu | 6000 | Philippines |
| Southern Philippines Medical Center | Davao City | Davao Del Norte | 8000 | Philippines |
| Angeles University Foundation and Medical Center | Angeles City | Pampanga | 2009 | Philippines |
| Chong Hua Medical Arts Center | Cebu City | 6000 | Philippines |
| Makati Medical Center | Makati City | 1229 | Philippines |
| St. Luke's Medical Center | Quenzon City | 1102 | Philippines |
| Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o. | Wroclaw | Lower Silesian Voivodeship | 53224 | Poland |
| Twoja Przychodnia Centrum Medyczne Nowa Sol | Nowa Sól | Lubusz Voivodeship | 67-100 | Poland |
| Medycyna Kliniczna | Warsaw | Masovian Voivodeship | 00874 | Poland |
| Reumatika - Centrum Reumatologii | Warsaw | Masovian Voivodeship | 02-691 | Poland |
| Gabinet Internistyczno- Reumatologiczny Piotr Adrian Klimiuk | Bialystok | Podlaskie Voivodeship | 15-077 | Poland |
| Zespol Poradni Specjalistycznych REUMED | Lublin | Polska | 20582 | Poland |
| Ambulatorium Barbara Bazela | Elblag | Warminsko-Mazurki | 82300 | Poland |
| Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej | Bydgoszcz | 85-168 | Poland |
| Centrum Medyczne Pratia Katowice | Katowice | 40-081 | Poland |
| Malopolskie Centrum Medyczne S.C. | Krakow | 30-510 | Poland |
| Centrum Medyczne Plejady | Krakow | 30363 | Poland |
| NZOZ Lecznica MAK-MED s.c. | Nadarzyn | 05-830 | Poland |
| Ortopedyczno-Rehabilitacyjny Szpital Kliniczny UM w Poznaniu | Poznan | 61-545 | Poland |
| Centrum Medyczne AMED | Warsaw | 03-291 | Poland |
| Napoca Emergency Clinical County Hospital | Cluj-Napoca | Cluj | 40006 | Romania |
| Craiova Emergency Clinical County Hospital | Craiova | Dolj | 200642 | Romania |
| SC CMDTA Neomed SRL | Brasov | 500283 | Romania |
| Spitalul Clinic Sf Maria Bucuresti | Bucharest | 011172 | Romania |
| Spitalul Clinic "Dr. Ioan Cantacuzino" | Bucharest | 020475 | Romania |
| SANA Medical Center | Bucharest | 11025 | Romania |
| St. Maria Clinical Hospital | Bucharest | 11172 | Romania |
| Spitalul Euroclinic | Bucureti | 014461 | Romania |
| Institute of Rheumatology | Belgrade | 11000 | Serbia |
| Military Medical Academy | Belgrade | 11000 | Serbia |
| University Clinical Center of Serbia | Belgrade | 11000 | Serbia |
| Institute for Treatment and Rehabilitation Niska Banja | Niška Banja | 18205 | Serbia |
| Clinical Center of Vojvodina | Novi Sad | 21000 | Serbia |
| Suite 509 Umhlanga Netcare Medical Centre | Umhlanga | Durban | 4319 | South Africa |
| Charlotte Maxeke Johannesburg Academic Hospital | Parktown | Guateng | 2000 | South Africa |
| Jakaranda Hospital | Muckleneuk | Pretoria | 0002 | South Africa |
| Panorama Medical Centre | Cape Town | Western Cape | 7506 | South Africa |
| Arthritis Clinical Trial Centre | Pinelands | Western Cape | 7405 | South Africa |
| Winelands Medical Research Centre | Stellenbosch | Western Cape | 7600 | South Africa |
| University Of Pretoria | Pretoria | 0002 | South Africa |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Kyung Pook National University Hospital | Daegu | Korea | 41944 | South Korea |
| Gachon University Gil Hospital | Incheon | Korea | 21565 | South Korea |
| Hanyang University Medical Center | Seoul | Korea | 04763 | South Korea |
| The Catholic University of Korea-Seoul St. Mary's Hospital | Seocho-Gu | Seoul | 06591 | South Korea |
| Asan Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] | 05505 | South Korea |
| Hospital Marina Baixa | Villajoyosa | Alicante | 03570 | Spain |
| Hospital De Fuenlabrada | Fuenlabrada | Madrid | 28944 | Spain |
| Hospital do Meixoeiro | Vigo | Pontevedra | 36200 | Spain |
| Corporacion Sanitaria Parc Tauli | Sabadell | Sapin | 08208 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Corporació Sanitària Clínic | Barcelona | 8036 | Spain |
| Hospital Quiron Infanta Luisa | Seville | 41010 | Spain |
| 33687069 | 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. |
Participants received one 2 mg baricitinib tablet and one placebo tablet matching 4 mg baricitinib administered QD for 52 weeks.
| FG002 | 4 mg Baricitinib | Participants received one 4 mg baricitinib tablet and one placebo tablet matching 2 mg baricitinib administered QD for 52 weeks. |
| Received at Least One Dose of Study Drug |
|
| Safety Population | All randomized participants who received at least one dose of study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. |
|
| Pharmacokinetic (PK) Population | Participants with estimated glomerular filtration rate less than (<) 60 milliliter/minute (mL/min)/1.73 square meter (m2) at screening randomized to the 4 mg dose received a dose of 2 mg QD. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 2 mg Baricitinib | Participants received one 2 mg baricitinib tablet and one placebo tablet matching 4 mg baricitinib administered QD for 52 weeks. |
| BG002 | 4 mg Baricitinib | Participants received one 4 mg baricitinib tablet and one placebo tablet matching 2 mg baricitinib administered QD for 52 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | All randomized participants who received at least one dose of study drug (modified intent-to-treat (mITT) population). The hybrid imputation method [nonresponder imputation (NRI) + multiple imputation (MI)] was used to estimate the response rate in percentage and not the number of responder. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | 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). | All randomized participants who received at least one dose of study drug (mITT population). The hybrid imputation method [nonresponder imputation (NRI) + multiple imputation (MI)] was used to estimate the response rate in percentage and not the number of responder. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | 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. | All randomized participants who received at least 1 dose of study drug (mITT population). The hybrid imputation method [nonresponder imputation (NRI) + multiple imputation (MI)] was used to estimate the response rate in percentage and not the number of responder. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | 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. | All randomized participants who received at least one dose of study drug (mITT population). | Posted | Median | 95% Confidence Interval | weeks | Baseline to Week 52 |
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| 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 | 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. | All randomized participants who received at least one dose of study drug (mITT population) and had received >7.5 mg prednisone at baseline. Missing data was imputed using the hybrid imputation method [NRI + mLOCF (modified last observation carried forward)]. | Posted | Number | percentage of participants | Baseline, Week 40 through Week 52 |
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| Secondary | 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. | All randomized participants 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). | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 52 |
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| Secondary | 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. | All randomized participants 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). | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 52 |
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| 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 | 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. | All randomized participants who received at least one dose of study drug (mITT population) and had baseline CLASI score >=10. Missing data was imputed using NRI method. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | 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. | All randomized participants who received at least one dose of study drug (mITT population) and had baseline and post-baseline values at the specified time point. | Posted | Least Squares Mean | Standard Error | tender joint count | Baseline, Week 52 |
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| Secondary | 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. | All randomized participants who received at least one dose of study drug (mITT population) and had baseline and post-baseline values at the specified time point. | Posted | Least Squares Mean | Standard Error | swollen joint count | Baseline, Week 52 |
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| Secondary | 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. | All randomized participants who received at least one dose of study drug with evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour/milliliter (ng*h/mL) | 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 | 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. | All randomized participants who received at least one dose of study drug with evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | 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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|
Baseline through Follow-up (Up to 56 Weeks)
All randomized participants who received at least one dose of study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit (safety population). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 3 | 256 | 26 | 256 | 96 | 256 |
| EG001 | 2 mg Baricitinib | Participants received one 2 mg baricitinib tablet and one placebo tablet matching 4 mg baricitinib administered QD for 52 weeks. | 0 | 261 | 35 | 261 | 100 | 261 |
| EG002 | 4 mg Baricitinib | Participants received one 4 mg baricitinib tablet and one placebo tablet matching 2 mg baricitinib administered QD for 52 weeks. | 4 | 258 | 32 | 258 | 96 | 258 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Food poisoning | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Intestinal pseudo-obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
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| Abscess jaw | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Coronavirus infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Covid-19 pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Cytomegalovirus colitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Disseminated varicella zoster virus infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Gastroenteritis salmonella | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Herpes zoster meningomyelitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Salmonellosis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Tubo-ovarian abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Typhoid fever | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Electrocardiogram t wave inversion | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
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| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
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| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
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| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Post herpetic neuralgia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 24.0 | Systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Lupus nephritis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
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| Nephrotic syndrome | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
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| Pelvi-ureteric obstruction | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
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| Ureterolithiasis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Genital prolapse | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
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| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Hip arthroplasty | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
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| Knee arthroplasty | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
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| Rehabilitation therapy | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
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| Thyroidectomy | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 8005455979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 1, 2021 | Jun 24, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000596027 | baricitinib |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Chile |
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| Colombia |
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| France |
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| India |
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| Italy |
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| Japan |
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| Philippines |
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| Poland |
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| Romania |
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| Serbia |
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| South Africa |
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| South Korea |
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| Spain |
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| United States |
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| 2 mg Baricitinib |
Participants received one 2 mg baricitinib tablet and one placebo tablet matching 4 mg baricitinib administered QD for 52 weeks. |
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| OG002 | 4 mg Baricitinib | Participants received one 4 mg baricitinib tablet and one placebo tablet matching 2 mg baricitinib administered QD for 52 weeks. |
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| OG002 | 4 mg Baricitinib | Participants received one 4 mg baricitinib tablet and one placebo tablet matching 2 mg baricitinib administered QD for 52 weeks. |
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| 2 mg Baricitinib |
Participants received one 2 mg baricitinib tablet and one placebo tablet matching 4 mg baricitinib administered QD for 52 weeks. |
| OG002 | 4 mg Baricitinib | Participants received one 4 mg baricitinib tablet and one placebo tablet matching 2 mg baricitinib administered QD for 52 weeks. |
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| OG002 | 4 mg Baricitinib | Participants received one 4 mg baricitinib tablet and one placebo tablet matching 2 mg baricitinib administered QD for 52 weeks. |
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| OG002 | 4 mg Baricitinib | Participants received one 4 mg baricitinib tablet and one placebo tablet matching 2 mg baricitinib administered QD for 52 weeks. |
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