Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0 Level: LLT Classification code 10079454 Term: Systemic juvenile idiopathic arthritis System Organ Class: 100000004859
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Patients are at least 1 year and less than 18 years of age; full date of birth will be collected except in countries in which it is not allowed. [2] Have a diagnosis of sJIA as defined by International League of Associations for Rheumatology (ILAR) criteria (Petty et al. 2004), with onset before the age of 16 years: Arthritis in 1 or more joints with or preceded by fever of at least 2 weeks’ duration that is documented to be daily (quotidian) fever for at least 3 days, and accompanied by 1 or more of the following: o Evanescent (nonfixed) erythematous rash o Generalized lymph node enlargement o Hepatomegaly and/or splenomegaly o Serositis [4] If participating in the PoC period, must have ? a diagnosis of sJIA as defined by the ILAR criteria ? at least 2 joints with active arthritis ? intermittently spiking fever >38°C within the week prior to enrollment ? hsCRP levels >1.5 x ULN, and ? eGFR =60 mL/min/1.73 m2. [5] Both a parent or legal guardian and the patient (as appropriate) are able to understand and fully participate in the activities of the clinical study and sign their consent and assent, respectively, in accordance with local guidelines. [6] Male or nonpregnant, nonbreastfeeding female patients a. Patients of childbearing potential who are abstinent (if this is complete abstinence, as their preferred and usual lifestyle) must agree to remain abstinent. b. Total abstinence is defined as refraining from intercourse during the entirety of the study and for at least 1 week following the last dose of investigational product. Periodic abstinence such as calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception. c. Otherwise, patients and their partners of childbearing potential must agree to use 2 effective methods of contraception, where at least 1 form is highly effective for the entirety of the study and for at least 1 week following the last dose of investigational product. The following contraception methods are considered acceptable (the patient, and their partner, should choose 2, and 1 must be highly effective [defined as less than 1% failure rate per year when used consistently and correctly]): ? Highly effective birth control methods: o Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal o Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or implantable o Intrauterine device/intrauterine hormone-releasing system o Vasectomized partner (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). ? Effective birth control methods: o Male or female condom with spermicide. It should be noted that the use of male and female condoms as a double-barrier method is not considered acceptable due to the high failure rate when these methods are combined. o Diaphragm with spermicide o Cervical sponge o Cervical cap with spermicide Note: When local guidelines concerning highly effective or effective methods of birth control differ from the above, the local guidelines must be followed. Adolescent females who have started menses (even 1 cycle and any amount of spotting) are considered to be of childbearing potential. Female patients of nonchildbearing potential are not required to use birth control and they are defined as: Females who are infertile due to surgical sterilization (hysterectomy, bilateral oo
Exclusion criteria
Exclusion criteria: [7] Have polyarticular JIA (positive or negative for rheumatoid factor), extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriatic arthritis. [8] Have persistent oligoarticular arthritis as defined by the ILAR criteria. [9] Have a history or presence of any autoimmune inflammatory condition other than JIA, such as Crohn’s disease or ulcerative colitis. [10] Have active anterior uveitis or are receiving concurrent treatment for anterior uveitis (patients with a history of uveitis should not be excluded). [11] Have active fibromyalgia or other chronic pain conditions that, in the investigator’s opinion, would make it difficult to appropriately assess disease activity for the purposes of this study. [12] Have biologic features of MAS such as hemorrhages, central nervous system dysfunction, hepatomegaly, plasma fibrinogen level <2.5 g/L, cytopenia, hypertriglyceridemia, decreased platelet count, increased AST, hyperferritinemia (Ravelli et al. 2005) at screening or a history of recurrent pericarditis, myocarditis, serositis and/or biologic features of MAS over the past 24 weeks. [13] Have a current or recent (<4 weeks prior to baseline) clinically serious viral, bacterial, fungal, or parasitic infection or 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. Note: For example, a recent viral upper respiratory tract infection or uncomplicated urinary tract infection need not be considered clinically serious. [14] Have had bone or joint infections within 6 months prior to screening. [15] Have symptomatic herpes simplex at baseline. [16] Have had symptomatic herpes zoster infection within 12 weeks prior to baseline. [17] Have a history of multidermatomal herpes zoster, complicated herpes zoster (e.g., ocular or motor nerve involvement or disseminated herpes zoster such as systemic infection). [18] Have a positive test for hepatitis B virus (HBV) at screening defined as: a. positive for hepatitis B surface antigen, or b. positive for hepatitis B core antibody (HBcAb) and positive for HBV deoxyribonucleic acid (DNA) [19] Have hepatitis C virus (HCV) infection (hepatitis C antibody positive and confirmed presence of HCV ribonucleic acid [RNA]). [20] Have evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies. [21] Have had household contact with a person with active tuberculosis (TB) and did not receive appropriate and documented prophylaxis for TB. [22] Have evidence of active TB or untreated/inadequately/inappropriately treated latent TB. [23] Had major surgery within 8 weeks prior to screening or will require major surgery during the study that in the opinion of the investigator in consultation with Lilly or its designee would pose an unacceptable risk to the patient. [24] Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data. [25] Have a history of a VTE or are considered at high risk of VTE as deemed by the investigator. [26] Are largely or wholly incapacitated, such as being bedridden. [27] Have a history of lymphoproliferative disease; or have signs or symptoms suggestive of possible l
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate the efficacy of baricitinib in children with sJIA. To assess the safety of baricitinib compared to placebo in patients with sJIA.;Primary end point(s): -Time to disease flare (defined as recurrence of fever lasting for 2 or more consecutive days, and/ or worsening of =30% in at least 3 of the 6 Pediatric American College of Rheumatology (PediACR) core criteria for JIA and an improvement of =30% in no more than 1 of the criteria) from the initiation of the double blind withdrawal period to the end of the double blind withdrawal period.;Timepoint(s) of evaluation of this end point: 32 weeks;Main Objective: To evaluate the efficacy of baricitinib compared to placebo in children with sJIA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Open Label Lead in Period: Changes from baseline in each of the 6 individual components of the PediACR Core Set variables as follows, with the addition of absence of spiking fever, as follows: -Number of active joints -Number of joints with limited range of motion -Physician's Global Assessment of Disease Activity -Parent's Global Assessment of Well-Being -Physical function as measured by the CHAQ -Acute-phase reactant hsCRP and erythrocyte sedimentation rate (ESR) - Proportion of patients without spiking fever Adapted PediACR 30/50/70/90/100 response rates at the end of the Open label lead in period. Proportion of patients with inactive disease. Proportion of patients with minimal disease activity. Double Blind Withdrawal period: Changes from the beginning of the OLLI period to the end of the DBW period (due to disease flare or completion) in each of the 6 individual components of the PediACR Core set, plus absence of spiking fever. Adapted PediACR 30/50/70/90/100 response rates at the end of the DBW period. Proportion of patients with disease flare. Proportion of patients with inactive disease Adverse events including serious AE's.;Timepoint(s) of evaluation of this end point: 24 weeks (Open label lead in period) and 32 weeks (Double Blind Withdrawal period) | — |
Countries
Argentina, Austria, Belgium, Brazil, China, Czech Republic, Denmark, France, Germany, India, Israel, Italy, Japan, Mexico, Poland, Russian Federation, Spain, Turkey, United Kingdom
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed