Moderately to severely active rheumatoid arthritis MedDRA version: 14.1 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 (CRP) (or hsCRP) measurement =6 mg/L • have had regular use of MTX for at least the 12 weeks prior to study entry at a dose that is considered acceptable to adequately assess clinical response. • have at least 1 joint erosion in hand, wrist, or foot joints based on radiographic interpretation by the central reader and be rheumatoid factor or anticyclic citrullinated peptide (anti-CCP) antibody positive; or have at least 3 joint erosions in hand, wrist, or foot joints based on radiographic interpretation by the central reader regardless of rheumatoid factor or anti-CCP antibody status 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 1685 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 255
Exclusion criteria
Exclusion criteria: • are currently receiving corticosteroids at doses >10 mg of prednisone per day (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 • are currently receiving or have received cDMARDs (eg, gold salts, cyclosporine, azathioprine, or any other immunosuppressives) other than MTX, hydroxychloroquine (up to 400 mg/day), or sulfasalazine (up to 3000 mg/day) within 8 weeks prior to study entry • have received leflunomide in the 12 weeks prior to study entry have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry • have ever received any biologic DMARD • have received interferon therapy within 4 weeks prior to study entry or are anticipated to require interferon therapy during the study • have received any parenteral corticosteroid administered by intramuscular or intravenous 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 any condition or contraindication for adalimumab that would preclude the patient from participating in this protocol • have active fibromyalgia that 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 o Patients with secondary Sjögren’s syndrome are not excluded. • have a diagnosis of Felty’s syndrome • have had any major surgery within 8 weeks prior to 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 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 a history of lymphoproliferative disease; or 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 duri
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine whether baricitinib is superior to placebo in the treatment of patients with moderately to severely active RA despite MTX treatment (i.e., MTX IR), as assessed by the proportion of patients achieving ACR20 at Week 12.;Secondary Objective: • change from baseline to Week 24 in structural joint damage as measured by modified Total Sharp Score (mTSS [van der Heijde method]) compared to placebo • change from baseline to Week 12 in Health Assessment Questionnaire-Disability Index (HAQ-DI) score compared to placebo • change from baseline to Week 12 in DAS28-high-sensitivity C-reactive protein (hsCRP) compared to placebo • proportion of patients achieving an SDAI score =3.3 at week 12 • proportion of patients achieving ACR20 response at Week 12 compared to adalimumab • proportion of patients achieving DAS28-hsCRP =3.2 and DAS28-hsCRP <2.6 at Week 12, Week 24, and Week 52 • change from baseline to Week 16 and Week 52 in structural joint damage as measured by mTSS • proportion of patients achieving DAS28-ESR =3.2 and DAS28-ESR <2.6 at Week 12, Week 24, and Week 52 ;Primary end point(s): Proportion of patients achieving ACR20 response compared to placebo .;Timepoint(s) of evaluation of this end point: Change from baseline to Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Modified Total Sharp Score (mTSS [van der Heijde method]) - Health Assessment Questionnaire Disability Index (HAQ-DI) - DAS28-high-sensitivity C-reactive protein (hsCRP) - 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 ACR20 response compared to adalimumab - proportion of patients achieving DAS28-ESR =3.2; proportion of patients achieving DAS28-ESR <2.6;Timepoint(s) of evaluation of this end point: - Modified Total Sharp Score (mTSS [van der Heijde method]): Change from baseline to Week 24 and 52 - Health Assessment Questionnaire Disability Index (HAQ-DI): Change from baseline to Week 12 - DAS28-high-sensitivity C-reactive protein (hsCRP): Change from baseline to Week 12 - Proportion of patients achieving ACR50 and ACR70 response: Change from baseline to Week 12, 24 and 52 - proportion of patients achieving DAS28-hsCRP =3.2; proportion of patients achieving DAS28- hsCRP <2.6: Weeks 12, 24 and 52 - proportion of patients achieving ACR20 response compared to adalimumab: Weeks 12 - proportion of patients achieving DAS28-ESR =3.2; proportion of patients achieving DAS28-ESR <2.6: Weeks 12, 24 and 52 | — |
Countries
Argentina, Australia, Belgium, Canada, China, Croatia, Czech Republic, France, Germany, Greece, Hungary, Israel, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, Poland, Portugal, Romania, Russian Federation, Slovakia, Slovenia, South Africa, Spain, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Eli Lilly
Outcome results
None listed