Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Otsuka Pharmaceutical Co., Ltd.
With
UCB Japan Co. Ltd.
Age
20–74
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects must have a diagnosis of adult-onset RA of at least 6 months but not longer than 15 years in duration as defined by the 1987 American College of Rheumatology classification criteria.
Subjects must have active RA disease as defined by:
* At least 9 tender joints and 9 swollen joints
* ESR of 30 mm/hour or CRP of 1.5 mg/dL
Subjects must have received treatment with MTX for at least 6 months prior to the start of study drug administration. The dose of MTX must have remain fixed for at least 2 months prior to the study and the dose of MTX should be within 6 to 8 mg/week.
You may not be if
Patients who have a diagnosis of any other inflammatory arthritis
Patients who have a secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
Patients who currently have, or who have a history of, a demyelinating or convulsive disease of the central nervous system (eg, multiple sclerosis, epilepsy)
Patients who have NYHA (New York Heart Association) Class III or IV congestive heart failure
Patients who currently have, or who have a history of, tuberculosis
Patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease)
Patients who currently have, or who have a history of, malignancy
Female patients who are breastfeeding or pregnant, who are of childbearing potential
Patients who previously received treatment with 2 or more anti-TNFα drugs or who previously failed to respond to treatment with 1 or more aint-TNFα drugs.
