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Examination of Efficacy and Safety of Baricitinib in RA Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03755466
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : December 3, 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. Baricitinib treatment for 12 months
  2. Biologics treatment for 12 months
  3. Tofacitinib treatment for 12 months

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: "Baricitinib", "olumiant®" Drug: "Biologics" Drug: Tofacitinib 5 MG [Xeljanz] Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Baricitinib in Rheumatoid Arthritis Patients Compared With Those Treated by Biologics or Tofacitinib
Actual Study Start Date : November 21, 2018
Estimated Primary Completion Date : November 20, 2019
Estimated Study Completion Date : November 20, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: BARI Drug: "Biologics"
To examine the effects of biologics in RA patients

Drug: Tofacitinib 5 MG [Xeljanz]
To examine the effects of tofacitinib in RA patients

Active Comparator: Bio Drug: "Baricitinib", "olumiant®"
To examine the effects of baricitinib in RA patients

Drug: Tofacitinib 5 MG [Xeljanz]
To examine the effects of tofacitinib in RA patients

Active Comparator: Tofa Drug: "Baricitinib", "olumiant®"
To examine the effects of baricitinib in RA patients

Drug: "Biologics"
To examine the effects of biologics in RA patients




Primary Outcome Measures :
  1. Assessment of Disease Activity in rheumatoid patients for 1 year treated by baricitinib (N=30), biologics (N=30), or tofacitinib (N=30). Also, the efficacy and adverse event of each drug for 1 year in the RA patients. [ Time Frame: Change from Baseline Values of DAS28-CRP at 1 year in each group ]


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Ages Eligible for Study:   20 Years and older   (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): NCT03755466


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, Lecturer at Shinshu University School of Medicine, Shinshu University
ClinicalTrials.gov Identifier: NCT03755466    
Other Study ID Numbers: BARI2018
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 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
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action