UMIN ID: UMIN000054609
Registered date:07/06/2024
A Biomarker-Based Evaluation Study of the Immediate Response of Ozoralizumab, an Anti-TNFa Antibody
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Rheumatoid arthritis |
| Date of first enrollment | 2024/05/16 |
| Target sample size | 150 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Comparison of mean change in CDAI at 24 weeks in the Ozoralizumab and Certolizumab pegol groups |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Patients with severe infections 2) Patients with active TB 3) Patients with a history of hypersensitivity to OZR 4) Patients with a history of demyelinating disease 5) Patients with congestive heart failure 6) Patients for whom TNF inhibitors are contraindicated in the Guidance on the Use of TNF Inhibitors for Rheumatoid Arthritis (revised 2023) by the Japan College of Rheumatology. 7) Other patients deemed inappropriate for the study by the principal investigator. |
Related Information
| Primary Sponsor | The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Taisho Pharmaceutical Co., Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Masanobu Ueno |
| Address | 1-1 Iseigaoka, Yahata-nishi, Kitakyushu 807-8555, Japan Japan 807-8555 |
| Telephone | 093-603-1611 |
| masanobu-ueno@clnc.uoeh-u.ac.jp | |
| Affiliation | University of Occupational and Environmental Health, Japan First Department of Internal Medicine |
| scientific contact | |
| Name | Yoshiya Tanaka |
| Address | 1-1 Iseigaoka, Yahata-nishi, Kitakyushu 807-8555, Japan Japan |
| Telephone | 093-603-1611 |
| tanaka@med.uoeh-u.ac.jp | |
| Affiliation | University of Occupational and Environmental Health, Japan First Department of Internal Medicine |