A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1280

Inclusion Criteria

Entry 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 (Aletaha et al. 2010)
• 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, in accordance with local clinical practice, is considered acceptable to adequately assess clinical response. The dose of MTX must have been a stable, unchanging oral dose of 7.5 to 25 mg/week (or the equivalent injectable dose) for at least the 8 weeks prior to study entry.
• are able to read, understand, and give written informed consent
Enrollment Criteria:
• have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints assessed at Visit 1 and Visit 2 at the time of randomization
• have an hsCRP measurement =6 mg/L based on Visit 1 laboratory results by central laboratory testing
• 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 (radiographic images acquired within 4 weeks of study entry may be submitted to the central reader to confirm eligibility)
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

Entry Criteria:
•are currently receiving corticosteroids at doses >10 mg of prednisone per day 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 randomization
•are currently receiving concomitant treatment with MTX, hydroxychloroquine,sulfasalazine
•are currently receiving or have received cDMARDs other than MTX, hydroxychloroquine,sulfasalazine 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 bDMARD
•have received interferon therapy within 4 weeks prior to study entry or anticipated to require interferon therapy during the study
•have received any parenteral corticosteroid administered by IM or IV inj. within 2 weeks prior entry or within 6 weeks prior to randomization or are anticipated to require parenteral inj. of corticosteroids during the study
•had 3 or more joints injected with intraarticular corticosteroids within 2 weeks prior to study entry or within 6 weeks prior to randomization
•have any condition or contraindication for adalimumab
•have active fibromyalgia that would make it difficult to appropriately assess RA activity for the study
•have a diagnosis of any systemic inflammatory condition other than RA
•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
•have experienced within 12 weeks of study entry:myocardial infarction,unstable ischemic heart disease,stroke,NYHAS4 heart failure
•have a history or presence of cardiovascular,respiratory, hepatic,gastrointestinal,endocrine,hematological,neurological, neuropsychiatric disorders or any other serious and/or unstable illness
•are largely/wholly incapacitated permitting little/no self-care
•have an eGFR<40 mL/min/1.73m2
•have a history of chronic liver disease
•have a history of, lymphoproliferative disease or signs or symptoms suggestive of possible lymphoproliferative disease or active primary or recurrent malignant disease or been in remission from clinically significant malignancy for<5 years
•have been exposed to a live vaccine within 12 weeks prior to randomization or are expected to receive a live vaccine during the study
•have a current/recent clinically serious viral,bacterial,fungal, parasitic infection
•have had symptomatic herpes zoster infection within 12 weeks prior to study entry
•have a history of disseminated/complicated herpes zoster
•are immunocompromised
•have a history of active HBV,HCV,HIV
•have had contact with a person with active TB and did not receive prophylaxis
•have evidence of active TB and did not receive TRT
•are pregnant,nursing
•are females of childbearing potential who do not agree to use 2 forms of highly effective birth control
•are males who do not agree to use 2 forms of highly effective birth control
•have donated >500 mL of blood within 30 days prior to study entry
•have history of chronic alcohol abuse,intravenous drug abuse,other illicit drug abuse within the 2 years prior to study entry
•have previously been randomized in this study or any other study
investigating baricitinib
•are unable or unwilling t