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An Extension Study of TS-152 in Subjects with Rheumatoid Arthritis

An Extension Study of TS-152 in Subjects with Rheumatoid Arthritis

401

Of 401 FAS subjects, all subjects were Japanese. At the start of the previous trials (TS152-3000-JA or TS152-3001-JA), 75.3% were female, the mean age was 55.0 years (SD, 11.6) , the mean weight was 58.63 kg (SD, 12.90) and the mean duration of rheumatoid arthritis was 7.6 years (SD, 7.4). 9.2% of subjects (37/401) were not receiving csDMARDs, 76.1% (305/401) were receiving MTX and 14.7% (59/401) were receiving csDMARDs except for MTX.

401 patients (217 in 30 mg group and 184 in 80 mg group) were administrated investigational drug in treatment period. Of them, 279 patietns (152 and 127, respectively)completed the trial. Patients who received 80 mg of treatment changed their dose to 30 mg after determining the approval submission dose of 30 mg. The maximum duration of treatment was 172 weeks.

The incidence of adverse event (AE) was 95.9% in the 30mg group (208/217) and 97.3% in the 80 mg group (179/184).The incidence of adverse drug reaction (ADR) was 45.2% in the 30mg group (98/217) and 41.3% in the 80 mg group (76/184). No deaths were reported. No adverse device reactions were reported.

ACR20 response rate,one of efficacy endpoints, at week 104 (OC) was 89.0% in the 30 mg group (154/173) and 89.7% in the 80 mg group (131/146), and the efficacy was observed through 168 weeks.

With regard to the other endpoints [ACR50, ACR70, DAS28-CRP, DAS28-ESR, ACR-N, TJC(68), SJC(66), Pt-GA, Ph-GA, Pt-PA, EULAR response rate (CRP), EULAR response rate (ESR), CDAI, SDAI, Boolean remission rate, HAQ-DI], the improvement was observed in 30 mg and 80mg group.

Long-term administration of TS-152 showed improvement in all of efficacy measures at week 104 and through 168 weeks in RA patients who completed the previous trials. No new safety concerns were observed with long-term administration of TS-152 and it was well tolerated.

Aug. 22, 2024

https://rmdopen.bmj.com/content/10/3/e004480.info

No

Taisho Pharmaceutical Co.Ltd

3-24-1 Takada,Toshima-ku,Tokyo JAPAN

clinical-trials@taisho.co.jp

Taisho Pharmaceutical Co.Ltd

3-24-1 Takada,Toshima-ku,Tokyo JAPAN

+81-3-3985-1118

clinical-trials@taisho.co.jp

completed

Oct. 01, 2019

Interventional

Open-label, Multicenter study

treatment purpose

3

(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.

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.

Both

Rheumatoid Arthritis

investigational material(s)
Generic name etc : ozoralizumab
INN of investigational material : ozoralizumab
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : Subcutaneous injection of TS-152 30mg or TS-152 80mg every 4 weeks

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

safety
efficacy
ACR20
adverse event,Side effects
etc.

other
-

Sept. 19, 2019