Moderately to severely active rheumatoid arthritis MedDRA version: 16.1 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: • are at least 18 years of age • have a diagnosis of adult-onset RA as defined by the ACR/EULAR 2010 Criteria for the Classification of RA • have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints • have a C-reactive protein (or hsCRP) measurement =1 times the upper limit of normal (ULN) • have been treated at approved doses with at least 1 biologic TNF- a inhibitor and either: - experienced insufficient efficacy or loss of efficacy - experienced intolerance of such treatment • have had regular use of at least 1 cDMARD for at least the 12 weeks prior to study entry with a continuous, nonchanging dose for at least 8 weeks prior to study entry 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • have received a biologic treatment for RA within 28 days of planned randomization • are currently receiving corticosteroids at doses >10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization • have started treatment with NSAIDs or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization • are currently receiving concomitant treatment with MTX, hydroxychloroquine, and sulfasalazine or combination of any 3 cDMARDs. • have received any parenteral corticosteroid administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study • have had 3 or more joints injected with intraarticular corticosteroids within 2 weeks prior to study entry or within 6 weeks prior to planned randomization • have active fibromyalgia that, in the investigator’s opinion, would make it difficult to appropriately assess RA activity for the purposes of this study • have a diagnosis of any systemic inflammatory condition other than RA, such as, but not limited to juvenile chronic arthritis, spondyloarthropathy, Crohn’s disease, ulcerative colitis, psoriatic arthritis, or active vasculitis - Patients with secondary Sjogren’s syndrome are not excluded. • have a diagnosis of Felty’s syndrome • have had any major surgery within 8 weeks of study entry 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 • have experienced any of the following within 12 weeks of study entry: myocardial infarction, unstable ischemic heart disease, stroke, or have New York Heart Association stage IV heart failure • 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 a risk when taking investigational product or could interfere with the interpretation of data • are largely or wholly incapacitated permitting little or no self care, such as, being bedridden or confined to a wheelchair • have an eGFR based on the most recent available serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of 1.5 times the ULN or the most recent available total bilirubin ?1.5 times the ULN • have, or have a history of, lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for <5 years • have been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination) • have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection • have had symptomatic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine whether baricitinib 4 mg QD is superior to placebo in the treatment of patients with moderately to severely active RA who have had an inadequate response to a TNF inhibitor, despite ongoing treatment with cDMARDs, as assessed by the proportion of patients achieving ACR20 at Week 12.;Secondary Objective: - change from baseline to Week 12 in Health Assessment Questionnaire-Disability Index (HAQ-DI) score (baricitinib 4mg compared to placebo) - change from baseline to Week 12 in DAS28-high-sensitivity C-reactive protein (hsCRP) (baricitinib 4mg compared to placebo) - proportion of patients achieving ACR20 at Week 12 (baricitinib 2mg compared to placebo) - change from baseline to Week 12 in HAQ-DI score (baricitinib 2mg compared to placebo) - change from baseline to Week 12 in DAS28-hsCRP (baricitinib 2mg compared to placebo) ;Primary end point(s): Proportion of patients achieving ACR20 response (baricitinib 4mg compared to placebo) ;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Health Assessment Questionnaire-Disability Index (HAQ-DI) score - DAS28-high-sensitivity C-reactive protein (hsCRP) - Proportion of patients achieving ACR20 response (baricitinib 2mg compared to placebo) - Proportion of patients achieving ACR20 response - Proportion of patients achieving ACR50 and ACR70 response - proportion of patients achieving DAS28-hsCRP =3.2; proportion of patients achieving DAS28- hsCRP <2.6 - proportion of patients achieving DAS28-ESR =3.2; proportion of patients achieving DAS28- ESR <2.6 ;Timepoint(s) of evaluation of this end point: - Health Assessment Questionnaire-Disability Index (HAQ-DI) score: Change from baseline to Weeks 12 and 24 - DAS28-high-sensitivity C-reactive protein (hsCRP): Change from baseline to Weeks 12 and 24 - Proportion of patients achieving ACR20 response (baricitinib 2mg compared to placebo): Week 12 - Proportion of patients achieving ACR20 response: Week 24 - Proportion of patients achieving ACR50 and ACR70 response: Weeks 12 and 24 - proportion of patients achieving DAS28-hsCRP =3.2; proportion of patients achieving DAS28- hsCRP <2.6: Weeks 12 and 24 - proportion of patients achieving DAS28-ESR =3.2; proportion of patients achieving DAS28- ESR <2.6: Weeks 12 and 24 | — |
Countries
Argentina, Australia, Austria, Belgium, Canada, Croatia, Denmark, France, Germany, Greece, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Spain, Switzerland, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Eli Lilly
Outcome results
None listed