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

NCT04077567 | Completed Phase 3

• 1 other identifier: TS152-3002-JA
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 1

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).

Conditions

Rheumatoid Arthritis

Keywords

RA

Outcome Measures

Primary Outcomes (2)

• 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.

  through study completion, an average of 3 year

• 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).

  through study completion, an average of 3 year

Study Arms (2)

TS-152 30mg SC

EXPERIMENTAL

TS-152 30mg subcutaneously (SC) every 4 weeks

Drug: TS-152

TS-152 80mg SC

EXPERIMENTAL

TS-152 80mg subcutaneously (SC) every 4 weeks

Drug: TS-152

Interventions

TS-152 DRUG

30mg,80mg

Also known as: ozoralizumab

TS-152 30mg SC; TS-152 80mg SC

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taisho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Location

Related Publications (1)

• Tanaka Y, Miyazaki Y, Kawanishi M, Yamasaki H, Takeuchi T. Long-term safety and efficacy of anti-TNF multivalent VHH antibodies ozoralizumab in patients with rheumatoid arthritis. RMD Open. 2024 Aug 22;10(3):e004480. doi: 10.1136/rmdopen-2024-004480.

  PMID: 39179257 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 4, 2019
• Study Start: October 1, 2019
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: February 28, 2025

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)