- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03784261
Usefulness of Non TNF Usage in RA Patients
September 20, 2021 updated by: Yukio Nakamura, Shinshu University
Usefulness of Non TNF Usage in Rheumatoid Arthritis Patients
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nagano
-
Matsumoto, Nagano, Japan, 3908621
- Recruiting
- Yukio Nakamura
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: SAR, usually subucutaneous injection every 2 weeks
|
To examine the effects of salirumab in RA patients
To examine the effects of tocilizmab in RA patients
To examine the effects of abatacept in RA patients
|
Active Comparator: TCZ, usually subucutaneous injection every 2 weeks
|
To examine the effects of salirumab in RA patients
To examine the effects of tocilizmab in RA patients
To examine the effects of abatacept in RA patients
|
Active Comparator: ABT, usually subucutaneous injection every week
|
To examine the effects of salirumab in RA patients
To examine the effects of tocilizmab in RA patients
To examine the effects of abatacept in RA patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Values of DAS28-CRP
Time Frame: Baseline and 1 year
|
Assessment of efficacy in rheumatoid arthritis patients for 1 year treated by salirumab (N=30), tocilizumab (N=30), or abatacept (N=30).
|
Baseline and 1 year
|
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
|
at 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 17, 2018
Primary Completion (Anticipated)
December 16, 2022
Study Completion (Anticipated)
December 16, 2024
Study Registration Dates
First Submitted
December 17, 2018
First Submitted That Met QC Criteria
December 20, 2018
First Posted (Actual)
December 21, 2018
Study Record Updates
Last Update Posted (Actual)
September 21, 2021
Last Update Submitted That Met QC Criteria
September 20, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Immune Checkpoint Inhibitors
- Abatacept
Other Study ID Numbers
- NonTNF 2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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