Rheumatoid Arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion 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
Exclusion criteria: •Participants must not have any problems taking a tumor necrosis factor (TNF) inhibitor. •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. •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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Australia, Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Switzerland, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed