A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)
16. listopadu 2018 aktualizováno: Eli Lilly and Company
A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Phase 2 Study of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as baricitinib in participants with systemic lupus erythematosus.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
314
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Ciudad Autonoma de Buenos Aire, Argentina, C1204AAD
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ciudad Autonoma de Buenos Aire, Argentina, C1417EYG
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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San Juan, Argentina, J5402DIL
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San Miguel de Tucuman, Argentina, T4000AXL
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San Miguel de Tucuman, Argentina, T4000BRD
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Bordeaux, Francie, 33076
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Marseille, Francie, 13003
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Pessac Cedex, Francie, 33604
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Strasbourg CEDEX, Francie, 67098
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Asahikawa, Japonsko, 070-8644
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Chuo-Ku, Japonsko, 104-8560
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Fukuoka, Japonsko, 810-8563
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Hamamatsu, Japonsko, 430-8558
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Itabashi-ku, Japonsko, 173-8610
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Kawagoe, Japonsko, 350-8550
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Kita-gun, Japonsko, 761-0793
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Kitakyushu, Japonsko, 807-8556
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Meguro-ku, Japonsko, 153-8515
- Meguro-kuFor additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nagasaki, Japonsko, 852-8501
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Omura, Japonsko, 856-8562
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Sapporo, Japonsko, 060-8648
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Sasebo, Japonsko, 857-1195
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Sendai, Japonsko, 980-8574
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Gwangju, Korejská republika, 61469
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Incheon, Korejská republika, 22332
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Seoul, Korejská republika, 02447
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Seoul, Korejská republika, 03080
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Suwon, Korejská republika, 16499
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Guadalajara, Mexiko, 44650
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Guadalajara, Mexiko, 44690
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Mexico City, Mexiko, 06700
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Zapopan, Mexiko, 45030
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Bydgoszcz, Polsko, 85-168
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Bytom, Polsko, 41-902
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Elblag, Polsko, 82-300
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Gdansk, Polsko, 80-546
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Nadarzyn, Polsko, 05-830
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Swidnik, Polsko, 21-040
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Caguas, Portoriko, 00725
- Office: Perez-De Jesus, Amarilis
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San Juan, Portoriko, 00918
- Mindful Medical Research
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Santurce, Portoriko, 00909
- Latin Clinical Trial Center
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Graz, Rakousko, 8036
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wien, Rakousko, 1130
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Wien, Rakousko, 1090
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Brasov, Rumunsko, 500283
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Bucuresti, Rumunsko, 011172
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Galati, Rumunsko, 800587
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Targu Mures, Rumunsko, 540136
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Arizona
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Tucson, Arizona, Spojené státy, 85724
- University of Arizona
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California
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Beverly Hills, California, Spojené státy, 90211
- Wallace Rheumatic Study Center
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Covina, California, Spojené státy, 91723
- Medvin Clinical Research
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El Cajon, California, Spojené státy, 92020
- TriWest Research Assocaites
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La Jolla, California, Spojené státy, 92037
- University of California
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Palm Desert, California, Spojené státy, 92260
- Desert Medical Advances
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Upland, California, Spojené státy, 91786
- Inlande Rheumatology Clinical Trials
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Colorado
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Denver, Colorado, Spojené státy, 80230
- Denver Arthritis Center
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Florida
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Miami, Florida, Spojené státy, 33175
- New Horizon Research Center
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Tamarac, Florida, Spojené státy, 33321
- West Broward Rheumatology Associates, Inc
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Tampa, Florida, Spojené státy, 33603
- Clinical Research of West Florida, Inc.
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Kansas
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Overland Park, Kansas, Spojené státy, 66209
- Kansas City Internal Medicine Research
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Louisiana
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Monroe, Louisiana, Spojené státy, 71203
- The Arthritis & Diabetes Clinic Inc.
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Shreveport, Louisiana, Spojené státy, 71103
- Louisiana State University health Sciences Center
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48109
- University of Michigan
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Missouri
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Saint Louis, Missouri, Spojené státy, 63117
- Clayton Medical Research
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Saint Louis, Missouri, Spojené státy, 63141
- Arthritis Consultants
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New Mexico
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Albuquerque, New Mexico, Spojené státy, 87102
- Albuquerque Clinical Trials
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New York
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Great Neck, New York, Spojené státy, 11021
- North Shore University Hospital at Great Neck
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Ohio
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Columbus, Ohio, Spojené státy, 43203
- The Ohio State University
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Middleburg Heights, Ohio, Spojené státy, 44130
- Paramount Medical Research
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73103
- Arthritis & Rheumatology Center of Oklahoma PLLC
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Oklahoma City, Oklahoma, Spojené státy, 73104-5046
- Oklahoma Medical Research Foundation
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Tulsa, Oklahoma, Spojené státy, 74104
- The Oklahoma Center For Arthritis Therapy
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Pennsylvania
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Bethlehem, Pennsylvania, Spojené státy, 18015
- East Penn Rheumatology
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Wyomissing, Pennsylvania, Spojené státy, 19610
- Clinical Research Center of Reading, LLC
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Texas
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Allen, Texas, Spojené státy, 75013
- Accent Clinical Research Professionals, LLC
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Kaohsiung, Tchaj-wan, 83301
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Taichung, Tchaj-wan, 40447
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Taichung City, Tchaj-wan, 40201
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Taipei, Tchaj-wan, 10002
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Badalona, Španělsko, 08916
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Barcelona, Španělsko, 08035
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Madrid, Španělsko, 28041
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Madrid, Španělsko, 28007
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Vigo, Španělsko, 36200
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Have received a diagnosis of SLE at least 24 weeks prior to screening, meeting the American College of Rheumatology (ACR) 1982 revised criteria OR the 2012 Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria.
- Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA) as assessed by a central laboratory at screening.
- Have a SLEDAI-2K score ≥4 based on clinical symptoms (not including lab values) at randomization.
- Have active arthritis and/or active rash as defined by the SLEDAI-2K at randomization.
Exclusion Criteria:
- Have active severe lupus nephritis.
- Have active severe central nervous system (CNS) lupus.
- Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.
- Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.
- Are currently receiving oral corticosteroids at doses >20-milligrams per day of prednisone (or equivalent) or have adjusted the dose of corticosteroids within 2 weeks of planned randomization.
- Have started treatment with or adjusted the dose of nonsteroidal anti-inflammatory drugs (NSAIDs) (for which the NSAID use is intended for treatment of signs and symptoms of SLE) within 4 weeks of planned randomization.
- Have started treatment with or adjusted the dose of an antimalarial within 12 weeks of planned randomization.
- Have started treatment with or adjusted the dose of an immunosuppressant within 12 weeks of planned randomization.
- Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 2 mg Baricitinib
Participants received 2 (milligrams) mg of Baricitinib tablet orally once a day for 24 weeks.
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Podává se ústně
Ostatní jména:
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Experimentální: 4 mg Baricitinib
Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.
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Podává se ústně
Ostatní jména:
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Komparátor placeba: Placebo
Participants received Placebo orally once daily (QD) for 24 weeks.
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Podává se ústně
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of Participants Who Achieve Remission of Arthritis and/or Rash Defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Časové okno: Week 24
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Participants were defined as responder as follows using SLEDAI-2K definitions of arthritis and rash.
If only arthritis is present at baseline, then arthritis must be absent at Week 24 to meet the primary endpoint.
If only rash is present at baseline, then rash must be absent at Week 24 to meet the primary endpoint.
If both arthritis and rash are present at baseline, then the primary endpoint is met if either arthritis, or rash, or both arthritis and rash are absent at Week 24.
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Week 24
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of Participants Who Achieve SLE Responder Index 4 (SRI-4) Response
Časové okno: Week 24
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SRI-4 response is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores; and 3) no worsening (defined as an increase of ≥0.3 points [10 mm] from baseline) in Physician's Global Assessment of Disease Activity.
The SRI-4 is a composite index used to assess disease activity in SLE.
SLEDAI-2K assessment consists of 24 items with total score of 0 to 105, with higher scores representing increased disease activity.
BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to 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 is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe).
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Week 24
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Change From Baseline in SLEDAI-2K Score
Časové okno: Baseline, Week 24
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SLE Disease Activity Index 2000 (SLEDAI-2K) score is a weighted, cumulative index of lupus disease activity.
SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline of response, region, baseline disease activity (SLEDAI-2K <10, >=10), baseline anti-dsDNA status (positive, negative), treatment, time, treatment*time (type III sum of squares).
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Baseline, Week 24
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Change From Baseline in Patient's Global Assessment of Disease Activity
Časové okno: Baseline, Week 24
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The Patient's Global Assessment of Disease Activity is a single-item, patient reported scale developed for the assessment of the patient's overall rating of their disease activity due to SLE.
The scale measures disease activity through a 5 point Likert scale ranging from 0 ("No disease activity") to 4 ("Severe disease activity") at its worst over the past 7 days.
LS mean was determined by MMRM model with baseline of response, region, baseline disease activity (SLEDAI-2K <10, >=10), baseline anti-dsDNA status (positive, negative), treatment, time, treatment*time (type III sum of squares).
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Baseline, Week 24
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Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss)
Časové okno: Week (Wk) 0: 15-30 minutes (min) postdose; Wk 4: Predose, 1.5 - 4 hour (hr) postdose; Wk 8: 1 - 3 hr postdose; Wk 16: Predose
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Plasma samples for pharmacokinetic (PK) analysis were obtained in week 0, week 4, week 8, week 16 and 24.
AUC takes all time points post dose into account and one value is reported.
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Week (Wk) 0: 15-30 minutes (min) postdose; Wk 4: Predose, 1.5 - 4 hour (hr) postdose; Wk 8: 1 - 3 hr postdose; Wk 16: Predose
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Population Pharmacokinetics (PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss)
Časové okno: Week (Wk) 0: 15-30 minutes (min) postdose; Wk 4: Predose, 1.5 - 4 hour (hr) postdose; Wk 8: 1 - 3 hr postdose; Wk 16: Predose
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Plasma samples for pharmacokinetic (PK) analysis were obtained in week 0, week 4, week 8, week 16 and 24.
Cmax takes all time points post dose into account and one value is reported.
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Week (Wk) 0: 15-30 minutes (min) postdose; Wk 4: Predose, 1.5 - 4 hour (hr) postdose; Wk 8: 1 - 3 hr postdose; Wk 16: Predose
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
- Dorner T, Tanaka Y, Dow ER, Koch AE, Silk M, Ross Terres JA, Sims JT, Sun Z, de la Torre I, Petri M. Mechanism of action of baricitinib and identification of biomarkers and key immune pathways in patients with active systemic lupus erythematosus. Ann Rheum Dis. 2022 May 24;81(9):1267-72. doi: 10.1136/annrheumdis-2022-222335. Online ahead of print.
- Dorner T, van Vollenhoven RF, Doria A, Jia B, Ross Terres JA, Silk ME, de Bono S, Fischer P, Wallace DJ. Baricitinib decreases anti-dsDNA in patients with systemic lupus erythematosus: results from a phase II double-blind, randomized, placebo-controlled trial. Arthritis Res Ther. 2022 May 16;24(1):112. doi: 10.1186/s13075-022-02794-x.
- Wallace DJ, Furie RA, Tanaka Y, Kalunian KC, Mosca M, Petri MA, Dorner T, Cardiel MH, Bruce IN, Gomez E, Carmack T, DeLozier AM, Janes JM, Linnik MD, de Bono S, Silk ME, Hoffman RW. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet. 2018 Jul 21;392(10143):222-231. doi: 10.1016/S0140-6736(18)31363-1. Erratum In: Lancet. 2018 Aug 11;392(10146):476.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
24. března 2016
Primární dokončení (Aktuální)
12. října 2017
Dokončení studie (Aktuální)
9. listopadu 2017
Termíny zápisu do studia
První předloženo
10. března 2016
První předloženo, které splnilo kritéria kontroly kvality
10. března 2016
První zveřejněno (Odhad)
15. března 2016
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
21. listopadu 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
16. listopadu 2018
Naposledy ověřeno
1. prosince 2017
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 16270 (Jiný identifikátor: City of Hope Comprehensive Cancer Center)
- I4V-MC-JAHH (Jiný identifikátor: Eli Lilly and Company)
- 2015-004404-35 (Číslo EudraCT)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .