Early Rheumatoid Arthritis
Conditions
Sponsors
Astellas Pharma Inc.
UCB Japan CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects with RA as defined by the ACR/EULAR criteria (2010) who meet all of the following criteria. 1) Subjects must be at least 20 and under 65 years of age. 2) Subjects who developed RA within one year. 3) Subjects who have never received MTX before (MTX naive) 4) Subjects whose disease activity is moderate or more (DAS28(ESR) more than 3.2) 5) Subjects must satisfy at least two of the three criteria (Anti-CCP antibody positive, Rheumatoid factor positive, Presence of X-ray erosion) for poor prognosis. The anti-CCP antibody positive is essential for every patient.
Exclusion criteria
Exclusion criteria: *Patients who have a diagnosis of any other type of inflammatory arthritis. *Patients who have a secondary, non-inflammatory type of arthritis. *Patients who have used with MTX, reflunomide, or any other biologics prior to the start of study drug administration. *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 have a history of, malignant tumor *Female patients who are breastfeeding or pregnant, who are of childbearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Inhibition of radiographic progression at week 52 Change of mTSS | — |
Secondary
| Measure | Time frame |
|---|---|
| Inhibition of radiographic progression at week 24 Change of mTSS Clinical remission rate at week 24 and 52 DAS28(ESR) and ACR/EULAR remission | — |
Outcome results
None listed