UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054609 |
|---|---|
| Receipt number | R000062231 |
| Scientific Title | A Biomarker Based Evaluation Study of the Immediate Response of Ozoralizumab, an Anti TNFa Antibody |
| Date of disclosure of the study information | 2024/06/07 |
| Last modified on | 2024/06/07 19:54:11 |
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Basic information
Public title
A Biomarker-Based Evaluation Study of the Immediate Response of Ozoralizumab, an Anti-TNFa Antibody
Acronym
EAGLE study
Scientific Title
A Biomarker Based Evaluation Study of the Immediate Response of Ozoralizumab, an Anti TNFa Antibody
Scientific Title:Acronym
EAGLE study
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In addition to clarifying the early clinical effects of OZR under actual clinical conditions, comprehensive analysis of cytokines using electrochemiluminescence before and after OZR administration and detection of immunocompetent cell subsets using a multicolor cytometer will be performed to elucidate the mechanism of action in vivo and detect therapeutic predictive factors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of mean change in CDAI at 24 weeks in the Ozoralizumab and Certolizumab pegol groups
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Eligible patients are those who meet the 2010 ACR/EULAR RA classification criteria and have been diagnosed with RA.
2) Patients with a CDAI > 10.0 despite appropriate treatment with MTX in previous therapy are eligible.
3) For subjects in the OZR group, subjects who are able to provide written consent of their own volition (written consent) will be included.
4) Subjects must be at least 18 years of age.
5) Subjects must have no history of use of biologics and JAK inhibitors, for whom new OZR treatment will be initiated after the date of inclusion.
Key exclusion 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.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yoshiya |
| Middle name | |
| Last name | Tanaka |
Organization
University of Occupational and Environmental Health, Japan
Division name
First Department of Internal Medicine
Zip code
807-8555
Address
1-1 Iseigaoka, Yahata-nishi, Kitakyushu 807-8555, Japan
TEL
093-603-1611
tanaka@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Masanobu |
| Middle name | |
| Last name | Ueno |
Organization
University of Occupational and Environmental Health, Japan
Division name
First Department of Internal Medicine
Zip code
807-8555
Address
1-1 Iseigaoka, Yahata-nishi, Kitakyushu 807-8555, Japan
TEL
093-603-1611
Homepage URL
masanobu-ueno@clnc.uoeh-u.ac.jp
Sponsor or person
Institute
The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
Taisho Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Medical Research, University of Occupational and Environmental Health, Japan
Address
1-1 Iseigaoka, Yahata-nishi, Kitakyushu 807-8555, Japan
Tel
093-691-7205
daigakurinri@mbox.pub.uoeh-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Specific methods of the study
Study subjects OZR group
This study will include biologic and JAK inhibitor-naive RA patients with residual disease activity after appropriate treatment with MTX in the past. The OZR group included patients who received intensified treatment with OZR (30 mg once every four weeks).
Historical control CZP group
As a historical control, the CZP (certolizumab pegol, hereafter CZP) was introduced in biologic- and JAK inhibitor-naive RA patients in the TSUBAME study* reported by the department (400 mg every two weeks for the first three cycles, 200 mg every two weeks for the fourth and subsequent cycles). These patients were defined as the CZP group. CZP group. For the CZP group, existing information and samples (stored serum) from the TSUBAME study will be used (the period covered: March 2015-December 2020).
*Biomarker-based evaluation study of the immediate efficacy of the anti-TNF agent certolizumab pegol (Ethics no. H26-200).
To study the therapeutic efficacy and safety of both groups.
Management information
Registered date
| 2024 | Year | 06 | Month | 07 | Day |
Last modified on
| 2024 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062231
