Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Astellas Pharma Inc
With
UCB Japan Co. Ltd.
This study was initiated by Otsuka Pharmaceutical Co., Ltd and transferred to Astellas on 12/04/2012.
Age
20–64
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects with RA as defined by the ACR/EULAR criteria (2010) who meet all of the following criteria:
1. Subjects who developed RA within one year after onset of RA.
2. Subjects who have never received MTX before (MTX naive)
3. Subjects whose disease activity is moderate or higher (DAS28(ESR) ≥ 3.2）
4. Subjects must satisfy at least two of the three criteria (Anti-CCP antibody positive, Rheumatoid factor positive, Presence of X-ray erosion） for poor prognostic factors. The anti-CCP antibody positive is essential for every patient.
You may not be if
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
