A Phase 3b/4 Study in Rheumatoid Arthritis

• Register: EUCTR
• Last refreshed on: 15 April 2024
• Main ID: EUCTR2018-003351-37-PL
• Date of registration: 09/08/2019
• 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: 04/09/2019
• 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
• Affiliation: Eli Lilly

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

Key inclusion & exclusion criteria

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

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.


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)

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.

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.

Secondary Outcome(s)

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).

Secondary ID(s)

NCT03915964

I4V-MC-JAJA

2018-003351-37-GB

Source(s) of Monetary Support

Eli Lilly and Company

Ethics review

Status: Approved
Approval date: 02/07/2019
Contact: