Rheumatoid arthritis MedDRA version: 21.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
Pharmaceutical Form: Tablet
INN or Proposed INN: baricitinib
Current Sponsor code: LY3009104
Concentration unit: mg milligram(s)
Con
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Have completed the final active treatment study visit in Study I4V-MC-JADV, I4V-MC-JADZ, I4V-MC-JADX, 4V-MC-JADW, I4V-MC-JADA, or I4V-CR-JAGS. 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 3000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 350
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: [2] have significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous baricitinib study that, in the opinion of the investigator, pose an unacceptable risk to the patient if investigational product continues to be administered [3] have a known hypersensitivity to baricitinib or any component of this investigational product. [4] had investigational product permanently discontinued at any time during a previous baricitinib study [5] had temporary investigational product interruption at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for the patient’s participation in the study [6] have any other condition that, in the opinion of the investigator, renders the patient unable to understand the nature, scope, and possible consequences of the study or precludes the patient from following and completing the protocol [7] are females of childbearing potential who do not agree to use 2 forms of highly effective birth control when engaging in sexual intercourse while enrolled in the study and for at least 28 days following the last dose of investigational product [8] are males who do not agree to use 2 forms of highly effective birth control while engaging in sexual intercourse with female partners of childbearing potential while enrolled in the study and for at least 28 days following the last dose of investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate in patients initially randomized to receive baricitinib in the originating study, the effect of long-term administration of baricitinib on the progression of structural joint damage, joint space narrowing and bone erosion. score, duration of morning stiffness, and changes in the European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) scores and in healthcare resource utilization. To determine if treatment with baricitinib 2 mg QD maintains the low disease activity level achieved with the 4-mg QD dose on patients who maintain a CDAI score of =10 and Time to relapse after randomization to the baricitinib 2-mg and 4-mg QD doses;Main Objective: The primary objective of the study is to evaluate the long-term safety and tolerability of baricitinib. ;Primary end point(s): a) Proportion of patients experiencing Treatment emergent adverse events (TEAEs), adverse events of special interest, and serious adverse events (SAEs) over long term follow-up. b) Temporary study drug interruptions and/or permanent study drug discontinuations over the long term follow-up c) Vital signs and laboratory evaluations (including chemistry and hematology) ;Timepoint(s) of evaluation of this end point: a) All study visits. b) All study visits except Visits 1, 2, 5, and 801. c) All study visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Proportion of patients who maintain an improvement of 20, 50, or 70 percent, respectively, in the American College of Rheumatology criteria (ACR20, ACR50 and ACR70) b) Proportion of patients who maintain a • Disease Activity Score modified to include the 28 diathrodial joint count (DAS28)-high sensitivity C-reactive protein (hsCRP) DAS28 erythrocyte sedimentation rate (ESR)=3.2, DAS28-hsCRP 10 from Studies JADV, JADW, and JADX) after randomization to the baricitinib 2-mg and 4-mg QD doses;Timepoint(s) of evaluation of this end point: a) Change from Month 6 (of the originating study) through each 12 months of treatment b) same as a) c) Change from baseline of originating study through each 12 month of treatment d) same as c) e) same as c) f) Change from baseline in duration of morning stiffness through each 12 months of treatment g) Change from baseline through each 12 month of treatment h) All study visits I) All study visits | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, Poland, Portugal, Romania, Russian Federation, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed