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Usefulness of Non TNF Usage in RA Patients

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ClinicalTrials.gov Identifier: NCT03784261
Recruitment Status : Recruiting
First Posted : December 21, 2018
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Yukio Nakamura, Shinshu University

Brief Summary:

The aim of this study is to examine the efficacy and adverse events in the following 3 groups in rheumatoid arthritis patients:

  1. Sarilumab treatment for 12 months
  2. Tocilizmab treatment for 12 months
  3. Abatacept treatment for 12 months

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Drug: "Salirumab" Drug: Drug: "Tocilizmab" Drug: Drug: "Abatacept" Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Usefulness of Non TNF Usage in Rheumatoid Arthritis Patients
Actual Study Start Date : December 17, 2018
Estimated Primary Completion Date : December 16, 2019
Estimated Study Completion Date : December 16, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Arm Intervention/treatment
Active Comparator: SAR, usually subucutaneous injection every 2 weeks Drug: Drug: "Salirumab"
To examine the effects of salirumab in RA patients

Drug: Drug: "Tocilizmab"
To examine the effects of tocilizmab in RA patients

Drug: Drug: "Abatacept"
To examine the effects of abatacept in RA patients

Active Comparator: TCZ, usually subucutaneous injection every 2 weeks Drug: Drug: "Salirumab"
To examine the effects of salirumab in RA patients

Drug: Drug: "Tocilizmab"
To examine the effects of tocilizmab in RA patients

Drug: Drug: "Abatacept"
To examine the effects of abatacept in RA patients

Active Comparator: ABT, usually subucutaneous injection every week Drug: Drug: "Salirumab"
To examine the effects of salirumab in RA patients

Drug: Drug: "Tocilizmab"
To examine the effects of tocilizmab in RA patients

Drug: Drug: "Abatacept"
To examine the effects of abatacept in RA patients




Primary Outcome Measures :
  1. 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).

  2. 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 ]


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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03784261


Locations
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Japan
Yukio Nakamura Recruiting
Matsumoto, Nagano, Japan, 3908621
Contact: Yukio Nakamura, MD, PhD    +81-263-37-2659    yxn14@aol.jp   
Principal Investigator: Yukio Nakamura, MD, PhD         
Sponsors and Collaborators
Shinshu University

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Responsible Party: Yukio Nakamura, Principle Investigator, Shinshu University
ClinicalTrials.gov Identifier: NCT03784261     History of Changes
Other Study ID Numbers: NonTNF 2018
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Connective Tissue Diseases
Abatacept
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents