chronic inflammation of the joints and Rheumatoid Arthritis
Conditions
Interventions
Patients who have completed Study JADV, JADZ, JADX, or JADW will be assigned to
blinded baricitinib treatment (2 mg QD or 4 mg QD), and all patients who have
completed Study JADA will be assigned to
Sponsors
Eli Lilly
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. have completed the final active treatment study visit in Study I4V-MC-JADV, I4V-MC-JADZ, I4V-MC-JADX, JADW, or I4V-MC-JADA.
Exclusion criteria
Exclusion criteria: 1. 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 2. have a known hypersensitivity to baricitinib or any component of this investigational product. 3. had investigational product permanently discontinued at any time during a previous baricitinib study 4. 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 5. 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 6. 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 (see protocol page 33 for definition fertile age and approved contraception) 7. 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
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: The following efficacy measures will be assessed in this study: * ACR20, ACR50, and ACR70 indices * Hybrid ACR (bounded) response measure * DAS28-ESR and DAS28-hsCRP * EULAR28 * mTSS (includes joint space narrowing score and bone erosion score) * HAQ-DI * Simplified Disease Activity Index (SDAI) * CDAI | — |
Primary
| Measure | Time frame |
|---|---|
| Safety: The following safety measures will be assessed in this study: * adverse events (AEs) * AESI * SAEs * suspected unexpected serious adverse reactions (SUSARs) * concomitant medications * physical examinations * vital signs (blood pressure and pulse) and physical characteristics * standard laboratory tests (including hematology, clinical chemistry, urinalysis, lipid profile, eGFR, iron studies, hsCRP, and ESR) AESIs or laboratory results of special interest will include: * severe or opportunistic infections * venous thromboembolism (DVT/PE) * myelosuppressive events of anemia, leukopenia, neutropenia, lymphopenia, or thrombocytopenia * thrombocytosis * elevations in alanine aminotransferase or aspartate aminotransferase (>3 times the upper limit of normal [ULN]) with total bilirubin (>2 times the ULN) Patients with these laboratory-value-specified events will be identified using the same criteria for the interruption of investigational product with the exception of anemia, which will be identified using the same criteria for the discontinuation of investigational product, and thrombocytosis, which will be defined as a platelet count >600,000/*L. Health Outcomes: The following health outcome measures will be administered in this study: * duration of morning joint stiffness * EQ-5D-5L * Quick Inventory of Depressive Symptomatology Self-Rated-16 (QIDS-SR16) * healthcare resource utilization | — |
Countries
Netherlands
Outcome results
None listed