Back to resultsAn Extension Study of TS-152 in Subjects With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
TS-152
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring RA
Eligibility Criteria
Inclusion Criteria:
- At visit1(-4 weeks), Subject must be fully informed about the study and must obtain written informed consent from the subject himself.
- 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:
- Subjects who had serious adverse drug reactions in the previous study.
- At Visit1(-4 weeks) or Visit2 (0 week), Subjects who have not recovered from clinically important adverse events.
etc.
Sites / Locations
- Taisho Pharmaceutical Co., Ltd selected site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
TS-152 30mg SC
TS-152 80mg SC
Arm Description
TS-152 30mg subcutaneously (SC) every 4 weeks
TS-152 80mg subcutaneously (SC) every 4 weeks
Outcomes
Primary Outcome Measures
Incidence of adverse events
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
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT04077567
First Posted
August 29, 2019
Last Updated
May 10, 2023
Sponsor
Taisho Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04077567
Brief Title
An Extension Study of TS-152 in Subjects With Rheumatoid Arthritis
Official Title
An Extension Study of TS-152 in Subjects With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
April 28, 2023 (Actual)
Study Completion Date
April 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taisho Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
RA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
401 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TS-152 30mg SC
Arm Type
Experimental
Arm Description
TS-152 30mg subcutaneously (SC) every 4 weeks
Arm Title
TS-152 80mg SC
Arm Type
Experimental
Arm Description
TS-152 80mg subcutaneously (SC) every 4 weeks
Intervention Type
Drug
Intervention Name(s)
TS-152
Other Intervention Name(s)
ozoralizumab
Intervention Description
30mg,80mg
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
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.
Time Frame
through study completion, an average of 3 year
Title
ACR20
Description
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).
Time Frame
through study completion, an average of 3 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At visit1(-4 weeks), Subject must be fully informed about the study and must obtain written informed consent from the subject himself.
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:
Subjects who had serious adverse drug reactions in the previous study.
At Visit1(-4 weeks) or Visit2 (0 week), Subjects who have not recovered from clinically important adverse events.
etc.
Facility Information:
Facility Name
Taisho Pharmaceutical Co., Ltd selected site
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
An Extension Study of TS-152 in Subjects With Rheumatoid Arthritis
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