Main
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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:
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EUCTR |
Last refreshed on:
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12 March 2024 |
Main ID: |
EUCTR2018-003351-37-GR |
Date of registration:
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29/07/2019 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Phase 3b/4 Study in Rheumatoid Arthritis
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Scientific title:
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A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis
- RA-BRIDGE |
Date of first enrolment:
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13/09/2019 |
Target sample size:
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2600 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-003351-37 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Australia
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Austria
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Belgium
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Czech Republic
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Czechia
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Denmark
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France
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Germany
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Greece
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Hungary
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Israel
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Italy
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Lithuania
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Netherlands
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Poland
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Romania
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Russian Federation
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Slovakia
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South Africa
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Spain
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Switzerland
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Turkey
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Trial Registry Office
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Address:
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Lilly Corporate Center, DC 1526
Indianapolis
United States |
Telephone:
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Email:
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EU_Lilly_Clinical_Trials@lilly.com |
Affiliation:
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Eli Lilly |
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Name:
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Clinical Trial Registry Office
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Address:
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Lilly Corporate Center, DC 1526
Indianapolis
United States |
Telephone:
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Email:
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EU_Lilly_Clinical_Trials@lilly.com |
Affiliation:
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Eli Lilly |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis MedDRA version: 23.1
Level: PT
Classification code 10039073
Term: Rheumatoid arthritis
System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
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Intervention(s)
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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-
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Primary Outcome(s)
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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.
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Main Objective: To compare baricitinib (combined dose groups) to TNF inhibitors with respect to VTE.
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Primary end point(s): Time from first dose of study treatment to first event of Venous thromboembolism (VTE).
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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.
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Secondary Outcome(s)
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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
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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).
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Secondary ID(s)
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I4V-MC-JAJA
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2018-003351-37-GB
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NCT03915964
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Source(s) of Monetary Support
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Eli Lilly and Company
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Ethics review
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Status: Approved
Approval date: 13/09/2019
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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