World Health Organization site
Skip Navigation Links

Please fill this short user satisfaction survey


Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 12 March 2024
Main ID:  EUCTR2018-003351-37-GR
Date of registration: 29/07/2019
Prospective Registration: Yes
Primary sponsor: Eli Lilly and Company
Public title: A Phase 3b/4 Study in Rheumatoid Arthritis
Scientific title: A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis - RA-BRIDGE
Date of first enrolment: 13/09/2019
Target sample size: 2600
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-003351-37
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: yes Other trial design description: Blinded core study team members If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 3  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): yes
Countries of recruitment
Australia Austria Belgium Czech Republic Czechia Denmark France Germany
Greece Hungary Israel Italy Lithuania Netherlands Poland Romania
Russian Federation Slovakia South Africa Spain Switzerland Turkey United Kingdom United States
Contacts
Name: Clinical Trial Registry Office   
Address:  Lilly Corporate Center, DC 1526 Indianapolis United States
Telephone:
Email: EU_Lilly_Clinical_Trials@lilly.com
Affiliation:  Eli Lilly
Name: Clinical Trial Registry Office   
Address:  Lilly Corporate Center, DC 1526 Indianapolis United States
Telephone:
Email: EU_Lilly_Clinical_Trials@lilly.com
Affiliation:  Eli Lilly
Key inclusion & exclusion criteria
Inclusion criteria:
[1] Have a diagnosis of adult onset RA as defined by the 2010 Rheumatoid arthritis classification criteria: An American College of Rheumatology/European League against Rheumatism collaborative initiative (Aletaha et al. 2010)
[2] If RA symptom onset is <6 months, are rheumatoid factor or anticitrullinated antibody positive as assessed by the central laboratory during screening
[3] Have moderately to severely active RA defined as the presence of at least 3/28 tender joints and at least 3/28 swollen joints assessed at Visits 1 and 2. Joints with significant surgical treatment or injury cannot be counted towards the minimum number of tender and swollen joints for enrollment purposes
[4] Have had an inadequate response or intolerance to at least 1 DMARD (synthetic or biologic)
[5] Are male or female patients who are at least 18 years of age
[6] Have at least 1 of the following 4 characteristics:
a. Documented evidence of a VTE prior to this study
b. Age =60 years
c. BMI =30 kg/m2
d. Age 50 to <60 years AND BMI 25 to <30 kg/m2
[7] Nonpregnant, non breastfeeding female patient of childbearing potential:
a. Patients who are abstinent (if this is complete abstinence, as their preferred and usual lifestyle) or in a same sex relationship (as part of their preferred and usual lifestyle) must agree to either remain abstinent or stay in a same sex relationship without sexual relationships with the opposite sex during the entirety of the study and for 1 week after the last dose of baricitinib, 3 weeks after the last dose of etanercept, and 5 months after the last dose of adalimumab.
Total abstinence is defined as refraining from intercourse during the entirety of the study and for 1 week after the last dose of baricitinib, 3 weeks after the last dose of etanercept, and 5 months after the last dose of adalimumab. Periodic abstinence such as calendar, ovulation, symptothermal, postovulation methods, and withdrawal are not acceptable methods of contraception.
b. Otherwise, female patients must agree to use 1 highly effective method of contraception (defined as less than 1% failure rate per year when used consistently and correctly), such as combination oral contraceptives, implanted contraceptives, or intrauterine devices, for the entirety of the study and for 1 week after the last dose of baricitinib, 3 weeks after the last dose of etanercept, and 5 months after the last dose of adalimumab.
Female patients of non-childbearing potential may participate without requirements for contraception. This includes female patients who are
a. Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis; or
b. Postmenopausal – defined as either
i. A woman at least 50 years of age with an intact uterus, not on hormone therapy, who has had either
1. Cessation of menses for at least 1 year, or
2. At least 6 months of spontaneous amenorrhea with a follicle stimulating hormone >40 mIU/mL; or
ii. A woman 56 years of age or older not on hormone therapy, who has had at least 6 months of spontaneous amenorrhea; or
iii. A woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy.
[8] Must read and understand the informed consent and provide written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2080
F.1.3 Elderly (>=

Exclusion criteria:
[1] Have any contraindications or hypersensitivity to:
• a TNF inhibitor
• baricitinib
• the active substance, or
• any of the excipients listed in the SmPC Section 6.1
[2] Are pregnant or breastfeeding. Prior to initiation of treatment, female patients of childbearing potential must have a negative serum pregnancy test at the central laboratory during screening and a negative urine pregnancy test at Visit 2
[3] Have a history of VTE within 12 weeks prior to randomization or have a history of recurrent (>1) VTE
[4] Have active primary or recurrent malignant disease or have been in remission from clinically significant malignancy for <5 years prior to randomization
[5] Have active herpes zoster
[6] Have a clinically serious infection or have any other active or recent infection that in the opinion of the investigator would pose an unacceptable risk to the patient if participating in the study. This is also applicable to patients with evidence of HIV infection and/or who are positive for anti-HIV antibodies
[7] Have a history or presence of any illness that in the opinion of the investigator could pose an unacceptable risk to the patient if participating in the study or interfere with the interpretation of data
[8] Have had household contact with a person with active tuberculosis (TB) and did not receive appropriate and documented prophylaxis for TB
[9] Have evidence of active TB or untreated / inadequately / inappropriately treated for latent TB
[10] Have received more than 1 prior TNF inhibitor that was:
a. Discontinued for inadequate response for RA or
b. Discontinued for intolerance (AE) when used for any indication
[11] Have been treated with a bDMARD within 4 weeks of randomization (within 24 weeks of randomization for rituximab)
[12] Are being treated with more than 2 cDMARDs
[13] Have been treated with a JAK inhibitor
[14] Have received a live vaccine within 4 weeks of randomization or are expected to need/receive a live vaccine during the course of the study. Investigators should update immunizations (including, where applicable, herpes zoster) in agreement with current immunization guidelines prior to randomization
[15] Are being treated with a strong organic anion transporter 3 (OAT3) inhibitor, such as probenecid, that cannot be discontinued for the duration of the study
[16] Are being treated with an anticoagulant.Antiplatelet agents such as aspirin, clopidogrel, and prasugrel are not considered anticoagulants for the purpose of this study
[17] Have been previously enrolled in any baricitinib study
[18] Have any of the following:
a. ALT or AST >2 x the upper limit of normal (ULN)
b. alkaline phosphatase (ALP) =2 x ULN
c. total bilirubin level (TBL) =1.5 x ULN
d. hemoglobin <8 g/dL (80.0 g/L)
e. neutropenia (absolute neutrophil count <1000 cells/µL) (<1.00 x 103/µL or <1.00 GI/L)
f. lymphopenia (lymphocyte count <500 cells/µL) (<0.50 x 103/µL or <0.50 GI/L)
g. eGFR (Modification of Diet in Renal Disease) <30 mL/min/1.73 m2
[19] Have any screening laboratory test values outside the reference range for the population that in the opinion of the investigator pose an unacceptable risk for the patient’s participation in the study
[20] Have hepatitis B virus (HBV) infection defined as:
a. positive for hepatitis B surface antigen (HBsAg), or
b. positive for HBV DNA
[21] Have hepatitis C virus (HCV) infection defined as:
a. positive for hepatitis C antibody, and
b. positive for HCV ribonucleic acid [RNA]
[22] Are currently


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
MedDRA version: 23.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Intervention(s)

Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BARICITINIB
CAS Number: 1187594-09-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-

Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BARICITINIB
CAS Number: 1187594-09-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-

Trade Name: Enbrel
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: Humira
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)
Secondary Objective: •To compare baricitinib (combined dose groups) to TNF inhibitors with respect to key safety outcomes.
•To compare each baricitinib dose to TNF inhibitors with respect to key safety outcomes.
Main Objective: To compare baricitinib (combined dose groups) to TNF inhibitors with respect to VTE.
Primary end point(s): Time from first dose of study treatment to first event of Venous thromboembolism (VTE).
Timepoint(s) of evaluation of this end point: This endpoint will be evaluated at week 12, week 28, week 52 and every 24 weeks thereafter.
Secondary Outcome(s)
Secondary end point(s): • Time from first dose of study treatment (combined dose groups) to first event of:
o ATE
o MACE
o Malignancy (excluding NMSC)
o Opportunistic infection
o Serious infection

• Time from first dose of study treatment (each individual baricitinib dose) to first event of:
o VTE
o ATE
o MACE
o Malignancy (excluding NMSC)
o Opportunistic infection
o Serious infection
Timepoint(s) of evaluation of this end point: Endpoints will be evaluated at week 12, week 28, week 52 and every 24 weeks thereafter (all visits after randomisation).
Secondary ID(s)
I4V-MC-JAJA
2018-003351-37-GB
NCT03915964
Source(s) of Monetary Support
Eli Lilly and Company
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 13/09/2019
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history Please fill this short user satisfaction survey