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baricitinib treatment

Phase 3

Rheumatoid Arthritis | Small molecule | Immunology |Eli Lilly and Company|Last Updated: Mar 17, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials7
Total Enrollment6,433
FDA Designations
No designations recorded
Clinical Trials (7)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04870203Combination of Baricitinib and Anti-TNF in Rheumatoid ArthritisPHASE3 ACTIVE NOT_RECRUITING 160Jul 15, 2021Mar 1, 2027Mar 17, 202636 France, Monaco
NCT02265705A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis (RA)PHASE3 COMPLETED 290Oct 1, 2014May 1, 2017Sep 11, 201930 Argentina, Brazil +1
NCT01885078An Extension Study in Participants With Moderate to Severe Rheumatoid ArthritisPHASE3 COMPLETED 2,877Jun 27, 2013Nov 12, 2020Apr 25, 2022408 United States, Argentina +36
NCT01721044A Moderate to Severe Rheumatoid Arthritis StudyPHASE3 COMPLETED 527Jan 1, 2013Sep 1, 2014Sep 18, 2019103 United States, Argentina +20
NCT01721057A Study in Moderate to Severe Rheumatoid Arthritis ParticipantsPHASE3 COMPLETED 684Dec 1, 2012Dec 1, 2014Sep 18, 2019147 United States, Argentina +21
NCT01711359A Study in Participants With Moderate to Severe Rheumatoid ArthritisPHASE3 COMPLETED 588Nov 1, 2012Aug 1, 2015Sep 19, 2019154 United States, Argentina +17
NCT01710358A Study in Moderate to Severe Rheumatoid ArthritisPHASE3 COMPLETED 1,307Oct 1, 2012Sep 1, 2015Sep 18, 2019213 United States, Argentina +26
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Study Endpoints
Primary Endpoints
Proportion of patients who achieve an ACR 50 response
At weeks 24 after baseline

in each treatment group (COMBI group (anti-TNF therapy + baricitinib) vs. MONO group (baricitinib conventional therapy)).

Quantitative change in DAS28-CRP
At weeks 24 after baseline

in each treatment group (COMBI group (anti-TNF therapy + baricitinib) vs. MONO group (baricitinib conventional therapy)).

Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20)
Week 12

ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) \* 100.

Number of Participants Who Experienced Adverse Events (AEs) or Serious AE
Baseline through 84 Months

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (i.e., abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Non-serious AEs are reported at a threshold of 5%. An SAE is an AE from this study that results in any of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability/incapacity, congenital anomaly/birth defect, considered significant by the investigator for any other reason A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response - Placebo Versus Baricitinib 4 mg
Week 12

ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.

Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)
Week 12

ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). "ACR20 Responder" is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.

Secondary Endpoints
Proportion of adverse events (AE) and serious adverse events (SAE) in each treatment group
weeks 52 after baseline (Day 0)
Proportion of patients who achieve an ACR20 response in each treatment group
At weeks 4, 12 and 24 after baseline (Day 0)
Proportion of patients who achieve an ACR70 response in each treatment group
At weeks 4, 12 and 24 after baseline (Day 0)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Period A : baricitinib + anti-TNFEXPERIMENTAL -
Period A : baricitinib + placeboPLACEBO_COMPARATOR -
Period B : baricitinib + anti-TNFEXPERIMENTAL -
Period B : baricitinibACTIVE_COMPARATOR -
BaricitinibEXPERIMENTAL4 milligrams (mg) baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks. Participants will continue to take background methotrexate (MTX) therapy throughout study. Other background therapies, including non-steroidal anti-inflammatory drugs (NSAIDs) and low dose oral corticosteroids, are permitted during the study for participants who are on stable doses of these treatments at baseline.
PlaceboPLACEBO_COMPARATORPlacebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52. Participants will continue to take background MTX therapy throughout study. Other background therapies, including NSAIDs and low dose oral corticosteroids, are permitted during the study for participants who are on stable doses of these treatments at baseline.
4 milligram (mg) BaricitinibEXPERIMENTAL4 mg Baricitinib administered orally once daily. Participants received baricitinib doses according to the dose received at the completion of the originating study. Participants may continue to receive the background non-investigational, open-label conventional disease-modifying antirheumatic drugs (cDMARD), nonsteroidal anti-inflammatory drug (NSAID), corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
2 mg BaricitinibEXPERIMENTAL2 mg Baricitinib administered orally once daily. Participants received baricitinib doses according to the dose received at the completion of the originating study. Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
2 mg Baricitinib Step-downEXPERIMENTAL2 mg Baricitinib administered orally once daily in the 96-week Step-down period. Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
4 mg Baricitinib Step-downEXPERIMENTAL4 mg Baricitinib administered orally once daily in the 96-week Step-down period. Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
Baricitinib 2 mgEXPERIMENTALBaricitinib 2 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.
Baricitinib 4 mgEXPERIMENTALBaricitinib 4 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.
Baricitinib + MTXEXPERIMENTALBaricitinib 4 milligram (mg) administered orally once daily through Week 52. Participants received methotrexate (MTX) orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
MTXACTIVE_COMPARATORMTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
AdalimumabACTIVE_COMPARATORAdalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background methotrexate (MTX) therapy throughout study.
Interventions
NameTypeDescription
baricitinib treatmentDRUG4 mg daily during 12 months
anti-TNF therapyDRUGadalimumab at 40 mg every 2 weeks or etanercept 50 mg per week according to treatments history
PlaceboDRUG40 mg every 2 weeks during 6 months only during Period A
BaricitinibDRUGAdministered orally
cDMARDDRUGParticipants will continue to take background cDMARD therapy throughout study.
MethotrexateDRUGAdministered orally
Baricitinib PlaceboDRUGBaricitinib placebo administered orally once daily.
MTX PlaceboDRUGMTX placebo administered orally once weekly.
Folic AcidDRUGAdministered orally every day
AdalimumabDRUGAdministered SC
Adalimumab PlaceboDRUGAdalimumab placebo administered SC.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites36

Inclusion Criteria: * Male or female; * Age between 18 and 65 years-old; * Adult patient with a diagnosis of RA as defined by the ACR/EULAR 2010 criteria for the classification of RA; * Patient who presents an inadequate response to at least one bDMARD or tsDMARD for at least 12 weeks prior to stud...

Countries:FranceMonacoArgentinaBrazilChinaUnited StatesAustraliaAustriaBelgiumCanadaCroatiaCzechiaDenmarkGermanyGreeceHungaryIndiaIsraelItalyJapanLatviaLithuaniaMexicoNetherlandsPolandPortugalPuerto RicoRomaniaRussiaSlovakiaSloveniaSouth AfricaSouth KoreaSpainSwedenSwitzerlandTaiwanTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04870203primaryCompletionDate: changed
LOWMay 24, 2026NCT04870203studyFirstPostDate: changed