Rheumatoid Arthritis
Conditions
Sponsors
Otsuka Pharmaceutical Co., Ltd.
UCB Japan CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * 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 6 tender joints and 6 swollen joints - ESR of 28 mm/hour or CRP of 2.0 mg/dL * Subjects who have failed to respond or have been resistant to at least one DMARD (including MTX) * Subjects in whom MTX cannot be administered for any of the reasons(incomplete response/safety concerns)
Exclusion criteria
Exclusion criteria: * 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-TNF-alpha drugs or who previously failed to respond to treatment with 1 or more aint-TNF-alpha drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR20 responder rate Week12, 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| ACR20/50/70 responder rate Week1, 2, 4, 6, 8, 12,14, 16, 20, 24 DAS28 (ESR) Week1, 2, 4, 6, 8, 12, 14, 16, 18, 20, 24 Modified Total Sharp Score Week24 | — |
Outcome results
None listed