Rheumatoid Arthritis
Conditions
Brief summary
This post-marketing study is designed to compare the safety of baricitinib versus tumor necrosis factor (TNF) inhibitors with respect to venous thromboembolic events (VTEs) when given to participants with rheumatoid arthritis.
Interventions
DRUGBaricitinib
Administered orally.
DRUGTNF Inhibitor
Administered subcutaneously.
Sponsors
Eli Lilly and Company
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * 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. * Participants must have an inadequate response or intolerance to at least 1 disease-modifying antirheumatic drug (DMARD) (synthetic or biologic).
Exclusion criteria
* Participant should have no reason to not take a 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 start. * 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 | Description |
|---|---|---|
| Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Combined Baricitinib Dose Versus TNF Inhibitor] | From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants) | Time from first dose of study treatment to first event of VTE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/Body Mass Index (BMI) combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Individual Baricitinib Dose Versus TNF Inhibitor] | From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants) | Time from first dose of study treatment to first event of VTE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/Body Mass Index (BMI) combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables. |
| Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Arterial Thromboembolic Event (ATE) [Combined and Individual Baricitinib Dose Versus TNF Inhibitor] | From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants) | Time from first dose of study treatment to first ATE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables. |
| Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Major Adverse Cerebro-Cardiovascular Event (MACE) [Combined and Individual Baricitinib Dose Versus TNF Inhibitor] | From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants) | Time from first dose of study treatment to first MACE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables. |
| Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Malignancy (Excluding Nonmelanoma Skin Cancer [NMSC]) [Combined and Individual Baricitinib Dose Versus TNF Inhibitor] | From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants) | Time from first dose of study treatment to first malignancy (excluding NMSC) was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables. |
| Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Opportunistic Infection [Combined and Individual Baricitinib Dose Versus TNF Inhibitor] | From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants) | Time from first dose of study treatment to first opportunistic infection was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables. |
| Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Serious Infection [Combined and Individual Baricitinib Dose Versus TNF Inhibitor] | From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants) | Time from first dose of study treatment to first serious infection was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables. |
Countries
Australia, Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Lithuania, Netherlands, Poland, Puerto Rico, Romania, Russia, Slovakia, South Africa, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 60.10 years STANDARD_DEVIATION 9.87 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 76 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 724 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 80 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 16 Participants |
| Race (NIH/OMB) Asian | 26 Participants |
| Race (NIH/OMB) Black or African American | 89 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 47 Participants |
| Race (NIH/OMB) White | 2419 Participants |
| Region of Enrollment Australia | 7 Participants |
| Region of Enrollment Austria | 4 Participants |
| Region of Enrollment Belgium | 7 Participants |
| Region of Enrollment Czechia | 109 Participants |
| Region of Enrollment Denmark | 1 Participants |
| Region of Enrollment France | 16 Participants |
| Region of Enrollment Germany | 31 Participants |
| Region of Enrollment Greece | 8 Participants |
| Region of Enrollment Hungary | 41 Participants |
| Region of Enrollment Israel | 97 Participants |
| Region of Enrollment Italy | 8 Participants |
| Region of Enrollment Lithuania | 4 Participants |
| Region of Enrollment Netherlands | 13 Participants |
| Region of Enrollment Poland | 416 Participants |
| Region of Enrollment Romania | 39 Participants |
| Region of Enrollment Russia | 91 Participants |
| Region of Enrollment Slovakia | 17 Participants |
| Region of Enrollment South Africa | 103 Participants |
| Region of Enrollment Spain | 69 Participants |
| Region of Enrollment Switzerland | 1 Participants |
| Region of Enrollment Turkey | 15 Participants |
| Region of Enrollment United Kingdom | 46 Participants |
| Region of Enrollment United States | 225 Participants |
| Sex: Female, Male Female | 702 Participants |
| Sex: Female, Male Male | 551 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 16 / 886 | 32 / 886 | 23 / 887 |
| other Total, other adverse events | 498 / 879 | 538 / 881 | 475 / 880 |
| serious Total, serious adverse events | 259 / 879 | 276 / 881 | 259 / 880 |
Outcome results
None listed