search
Back to results

Usefulness of Non TNF Usage in RA Patients

Primary Purpose

Rheumatoid Arthritis

Status
Recruiting
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Drug: "Salirumab"
Drug: "Tocilizmab"
Drug: "Abatacept"
Sponsored by
Shinshu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

・RA patients

Exclusion Criteria:

  • Not RA patients
  • RA patients who are allergic to the drugs, refused to do this research, or who are pregnant

Sites / Locations

  • Yukio NakamuraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

SAR, usually subucutaneous injection every 2 weeks

TCZ, usually subucutaneous injection every 2 weeks

ABT, usually subucutaneous injection every week

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline Values of DAS28-CRP
Assessment of efficacy in rheumatoid arthritis patients for 1 year treated by salirumab (N=30), tocilizumab (N=30), or abatacept (N=30).
Assessment of adverse event in rheumatoid arthritis patients for 1 year treated by salirumab (N=30), tocilizumab (N=30), or abatacept (N=30).

Secondary Outcome Measures

Full Information

First Posted
December 17, 2018
Last Updated
September 20, 2021
Sponsor
Shinshu University
search

1. Study Identification

Unique Protocol Identification Number
NCT03784261
Brief Title
Usefulness of Non TNF Usage in RA Patients
Official Title
Usefulness of Non TNF Usage in Rheumatoid Arthritis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 17, 2018 (Actual)
Primary Completion Date
December 16, 2022 (Anticipated)
Study Completion Date
December 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shinshu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to examine the efficacy and adverse events in the following 3 groups in rheumatoid arthritis patients: Sarilumab treatment for 12 months Tocilizmab treatment for 12 months Abatacept treatment for 12 months

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SAR, usually subucutaneous injection every 2 weeks
Arm Type
Active Comparator
Arm Title
TCZ, usually subucutaneous injection every 2 weeks
Arm Type
Active Comparator
Arm Title
ABT, usually subucutaneous injection every week
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Drug: "Salirumab"
Intervention Description
To examine the effects of salirumab in RA patients
Intervention Type
Drug
Intervention Name(s)
Drug: "Tocilizmab"
Intervention Description
To examine the effects of tocilizmab in RA patients
Intervention Type
Drug
Intervention Name(s)
Drug: "Abatacept"
Intervention Description
To examine the effects of abatacept in RA patients
Primary Outcome Measure Information:
Title
Change from Baseline Values of DAS28-CRP
Description
Assessment of efficacy in rheumatoid arthritis patients for 1 year treated by salirumab (N=30), tocilizumab (N=30), or abatacept (N=30).
Time Frame
Baseline and 1 year
Title
Assessment of adverse event in rheumatoid arthritis patients for 1 year treated by salirumab (N=30), tocilizumab (N=30), or abatacept (N=30).
Time Frame
at 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ・RA patients Exclusion Criteria: Not RA patients RA patients who are allergic to the drugs, refused to do this research, or who are pregnant
Facility Information:
Facility Name
Yukio Nakamura
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
3908621
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yukio Nakamura, MD, PhD
Phone
+81-263-37-2659
Email
yxn14@aol.jp
First Name & Middle Initial & Last Name & Degree
Yukio Nakamura, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Usefulness of Non TNF Usage in RA Patients

We'll reach out to this number within 24 hrs