Study on Baricitinib (LY3009104) in Adults with Rheumatoid Arthritis

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 (ICTRP)

ICTRP Trial ID
EUCTR2018-003351-37 (ICTRP)

Official title (approved by ethics committee)
A Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. (BASEC)

Academic title
A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE (ICTRP)

Public title
Uno studio di fase 3b/4 sull'Artrite Reumatoide (ICTRP)

Disease under investigation
Rheumatoid Arthritis
MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] (ICTRP)

Intervention under investigation

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

Trade Name: Enbrel
Product Name: Enbrel
Product Code: [Enbrel]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETANERCEPT
Current Sponsor code: Enbrel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: Humira
Product Name: Humira
Product Code: [Humira]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: Humira
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

(ICTRP)

Type of trial
Interventional clinical trial of medicinal product (ICTRP)

Trial 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 (ICTRP)

Inclusion/Exclusion criteria
Gender:
Female: yes
Male: yes

Inclusion criteria:
Participants must have an inadequate response or intolerance to at least 1 disease-modifying antirheumatic drugs (DMARD) (synthetic or biologic).
Participants must have at least one of the following characteristics:
?Documented evidence of a VTE prior to this study
?At least 60 years of age or older
? A body mass index (BMI) greater than or equal to 30 kilograms per
meter squared (kg/m2), or
?Age 50 to less than 60 years AND BMI 25 to less than 30 kg/m2.
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 (>=65 years) yes
F.1.3.1 Number of subjects for this age range 520
(ICTRP)

Exclusion criteria:
Participants must not have any problems taking a tumor necrosis factor(TNF) inhibitor, baricitinib, the active substance, or any of the excipients listed in the SmPC Section 6.1.
Participants must not be pregnant or breastfeeding.
Participants must not have had more than one VTE.
Participants must not have cancer.
Participants must not have active herpes zoster, serious infection, active tuberculosis, or any other serious illness. This is also applicable to patients with evidence of HIV infection and/or who are positive for anti-HIV antibodies.
Participants must not have had a live vaccine within four weeks of study start.
Participants must not have participated in any other clinical trial within four weeks of study randomisation
Participants must not have a history of IV drug use, other illicit drug abuse, or chronic alcohol abuse in the past year.


Primary and secondary end points
Main Objective: To compare baricitinib (combined dose groups) to TNF inhibitors with respect to the risk of VTE.;Secondary Objective: ?To compare baricitinib (combined dose groups) to TNF inhibitors with respect to the risk of key safety outcomes.
?To compare each baricitinib dose to TNF inhibitors with respect to the risk of key safety outcomes.;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. (ICTRP)

Secondary end point(s): Time from first dose of study treatment (combined baricitinib doses compared to TNF inhibitors) to first event of:
Arterial thromboembolic event (ATE)
Major adverse cardiovascular events (MACE)
Malignancy (excluding Nonmelanoma skin cancer(NMSC))
Opportunistic infection
Serious infection
Time from first dose of study treatment (each individual baricitinib dose compared to TNF inhibitor) to first event of:
VTE
ATE
MACE
Malignancy (excluding NMSC)
Opportunistic infection
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). (ICTRP)

Registration date
15.06.2021 (ICTRP)

Incorporation of the first participant
20.08.2019 (ICTRP)

Secondary sponsors
not available

Additional contacts
Clinical Trial Registry Office, EU_Lilly_Clinical_Trials@lilly.com, Eli Lilly (ICTRP)

Secondary trial IDs
I4V-MC-JAJA, NCT03915964, 2018-003351-37-GB (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-003351-37 (ICTRP)