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A Phase III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Without Methotrexate (MTX) Therapy

A Phase III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Without Methotrexate (MTX) Therapy

140

Of 140 FAS subjects, all subjects were Japanese, and 79.3% were female. The mean age was 57.9 years (SD, 12.6) , the mean weight was 59.51 kg (SD, 13.98) and the mean duration of rheumatoid arthritis was 8.0 years (SD, 8.5) 51.4% of subjects (72/140) were receiving csDMARDs. No relevant imbalances among the treatment groups were noted in the demographic and other characteristics.

A total of 142 subjects were randomized and 140 subjects of them received the study drug (30 mg group: 94 subjects, 80 mg group: 46 subjects).Of 140 subjects who received the study drug, 101 subjects completed the study(30 mg group: 68 subjects, 80 mg group: 33 subjects).

The incidence of adverse event (AE) up to 52 weeks was 80.9% in the 30mg group (76/94) and 93.5% in the 80 mg group (43/46).The incidence of adverse drug reaction (ADR) up to 52 weeks was 39.4% in the 30mg group (37/94) and 50.0% in the 80 mg group (23/46). No deaths were reported. No adverse device reactions were reported.

ACR20 response rate, one of efficacy endpoints, at week 52 (LOCF) was 72.3% in the 30 mg group (68/94) and 78.3% in the 80 mg group (36/46).

With regard to the other endpoints [ACR50, ACR70, DAS28-CRP, DAS28-ESR, ACR-N, TJC(68), SJC(66), Pt-GA, Ph-GA, Pt-PA, duration of morning stiffness, EULAR response rate (CRP), EULAR response rate (ESR), CDAI, SDAI, Boolean remission rate, HAQ-DI, EQ-5D-5L], the improvement was observed in 30 mg and 80mg group at week 52.

TS-152 30 mg and 80 mg once every 4 weeks showed improvement in all of efficacy measures at week 52 without MTX in RA patients. TS-152 was well tolerated with no notable safety concerns at doses of 30 mg and 80 mg when administered subcutaneously up to 52 week.

Oct. 06, 2022

https://academic.oup.com/mr/advance-article/doi/10.1093/mr/roac126/6750002

No

-

https://www.clinicaltrials.jp/file/ckSLeqhgd

Taisho Pharmaceutical Co., Ltd.

clinical-trials@taisho.co.jp

Taisho Pharmaceutical Co., Ltd.

clinical-trials@taisho.co.jp

completed

Oct. 02, 2018

Interventional

Randomized, Open-label, Multicenter study

treatment purpose

3

- Patients diagnosed with RA based on the American College of Rheumatology (ACR) 2010 revised criteria for classification of RA

etc.

- Patients who are observed any abnormal findings suggestive of malignant tumor, infection, or interstitial pneumonia.
- Patients with severe cardiovascular, hepatic, and/or renal diseases.

etc.

Both

Rheumatoid Arthritis (RA)

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

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

safety
efficacy
pharmacokinetics
Safety, Efficacy, Pharmacokinetic

other
-

ー

Aug. 28, 2018