None listed
Conditions
Interventions
Subcutaneous injection 125mg/ml, single dose at day 1, in patients with Rheumatoid Arthritis
Study duration: 71 days.
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Men and women ≥ 18 years of age. 2) Diagnosis of Rheumatoid Arthritis confirmed by the subject´s physician 3) Disease activity that is under sufficient control such that the subject´s treating physician does not anticipate the need for change in therapy within the next three months.
Exclusion criteria
Exclusion criteria: 1) Subjects with a change in DMARD therapy within the 3 months prior to enrollment (screening) 2) Subjects who have been exposed to any investigational drug within 4 weeks or 5 half-lives, whichever is longer. 3) Current or Prior use of rituximab ≤ 6 months ago; if after > 6 months has elapsed since use, must have documented reconstitution of total peripheral B cell counts to a level within normal laboratory range. 4) Current or Prior use of any of the following within 4 weeks or 5 half-lives of enrollment, whichever is longer: biologic DMARDS, tofacitinib, cyclophosphamide, mycophenolate mofetil and d-Penicillamine
Countries
Argentina, Australia, Mexico, South Africa, United States
Contacts
Public ContactYanina Verdier
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed