Rheumatoid Arthritis
Conditions
Keywords
RA
Brief summary
To evaluate the long-term safety and efficacy of TS-152 in subjects with Rheumatoid Arthritis who have completed the previous study (TS152-3000-JA study or TS152-3001-JA study).
Interventions
DRUGTS-152
30mg,80mg
Sponsors
Taisho Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At visit1(-4 weeks), Subject must be fully informed about the study and must obtain written informed consent from the subject himself. 2. At Visit2(0 week), Subjects must have completed the previous study (TS152-3000-JA or TS152-3001-JA) ,and must have completed all evaluations required at the follow-up visit. etc.
Exclusion criteria
1. Subjects who had serious adverse drug reactions in the previous study. 2. At Visit1(-4 weeks) or Visit2 (0 week), Subjects who have not recovered from clinically important adverse events. etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | through study completion, an average of 3 year | To evaluate the Long-term safety of TS-152 in RA patients by incidence of adverse events which include vital signs, and clinical laboratory parameters. |
| ACR20 | through study completion, an average of 3 year | Percentage of Subjects who meet the American College of Rheumatology 20% (ACR20) Criteria from baseline of previous study (TS152-3001-JA or TS152-3001-JA). |
Countries
Japan
Outcome results
None listed