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Trial record 50 of 63 for:    Baricitinib

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

Tracking Information
First Submitted Date  ICMJE November 21, 2018
First Posted Date  ICMJE November 28, 2018
Last Update Posted Date December 3, 2018
Actual Study Start Date  ICMJE November 21, 2018
Estimated Primary Completion Date November 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2018)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 23, 2018)
Assessment of DAS28CRP and HAQ-DI in rheumatoid arthritis patients treated by baricitinib, biologics, or tofacitinib [ Time Frame: Change from Baseline Values of DAS28-CRP at 1 year in each group ]
Change History Complete list of historical versions of study NCT03755466 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Examination of Efficacy and Safety of Baricitinib in RA Patients
Official Title  ICMJE Efficacy and Safety of Baricitinib in Rheumatoid Arthritis Patients Compared With Those Treated by Biologics or Tofacitinib
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: "Baricitinib", "olumiant®"
    To examine the effects of baricitinib in RA patients
  • 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
Study Arms  ICMJE
  • Active Comparator: BARI
    Interventions:
    • Drug: "Biologics"
    • Drug: Tofacitinib 5 MG [Xeljanz]
  • Active Comparator: Bio
    Interventions:
    • Drug: "Baricitinib", "olumiant®"
    • Drug: Tofacitinib 5 MG [Xeljanz]
  • Active Comparator: Tofa
    Interventions:
    • Drug: "Baricitinib", "olumiant®"
    • Drug: "Biologics"
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 23, 2018)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 20, 2023
Estimated Primary Completion Date November 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03755466
Other Study ID Numbers  ICMJE BARI2018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yukio Nakamura, Shinshu University
Study Sponsor  ICMJE Shinshu University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shinshu University
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP