Ensayos clínicos

Inclusion Criteria:

• Males and Females ages 18-80 years old
• Active rheumatoid arthritis (RA) disease as per 2010 ACR/EULAR classification criteria for the diagnosis of RA.
• Must be positive for rheumatoid factor and/or anti-cyclic citrullinated peptide (anti-CCP3) but without extra-articular disease or severe functional limitation
• Patient with active RA defined as:
  • 4 tender joints (TJC) count (28 joint count) at screening and
  • 4 swollen joints (SJC) count (28 joint count) at screening
• ESR ≥ 28 mm/hr OR hsCRP greater than ULN
• Patient has been taking MTX for at least 4 months directly prior to screening, with dose and route of administration stable
• Patient has had an inadequate response to at least one TNFα inhibitor with last dose at least 6 weeks prior to screening
• Use of oral DMARD (sulfasalazine, hydroxychloroquine, chloroquine and leflunomide) besides MTX  must be stable for at least 3 months directly prior to screening 
• Female patients of childbearing potential who are surgically sterile and male patients who are surgically sterile must have had this surgery at least 3 months prior to randomization/first dose of study drug

Exclusion Criteria:

• Pregnant women or women who are breastfeeding.
• Other investigational therapy received within 8 weeks or five half-lives (whichever is longer) prior to Screening (except where otherwise excluded).
• Known or suspected alcohol or drug abuse within three years preceding Screening.
• Autoimmune disease other than RA (such as systemic lupus erythematosus (SLE), mixed connective tissue disease, scleroderma, polymyositis/dermatomyositis, vasculitis)
• History of or current inflammatory joint disease other than RA (such as tophaceous gout, reactive arthritis, psoriatic arthritis, ankylosing spondylitis or other spondyloarthropathy, Lyme disease). Patients primarily diagnosed with osteoarthritis are excluded.
• Bedridden or confined to a wheelchair or patients with > 3 arthroplasties due to RA.
• History of diagnosed and/or treated malignancy, with no evidence of recurrence, within the past 5 years. Treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ with no evidence of recurrence is allowable within the 5 years prior to screening
• Surgical procedures planned to occur during the trial (these patients may be rescreened following completion of and recovery from the surgical procedure).
• Use of TNFα inhibitor for treatment of RA at time of screening or within the 6 weeks prior to screening.
• Prior use of biologics for treatment of RA administered within 6 weeks prior to screening
• An exacerbation of asthma or COPD in the 1 month prior to screening
• Patient has current clinical, radiographic, or laboratory evidence of active TB or prior evidence of active TB that, in the opinion of the investigator, has not been adequately treated or controlled and that represents a reactivation risk. (Documented results from TB screening within 3 months prior to screening are sufficient to exclude risk, provided the results are negative.) 
• Clinically relevant heart disease or abnormal ECG at Screening, in the opinion of the investigator