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Evaluation of the Condition of Rheumatoid Arthritis After Treatment

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ClinicalTrials.gov Identifier: NCT02157012
Recruitment Status : Recruiting
First Posted : June 5, 2014
Last Update Posted : November 27, 2018
Sponsor:
Collaborator:
Showa Inan General Hospital
Information provided by (Responsible Party):
Yukio Nakamura, Shinshu University

Brief Summary:
To examine the safety and effectiveness after Xeljanz treatment in rheumatoid arthritis patients

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: The effectiveness of Xeljanz in rheumatoid arthritis patients Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Condition After Xeljanz Treatment in Rheumatoid Arthritis Patients
Study Start Date : May 2014
Actual Primary Completion Date : April 2016
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: The condition of rheumatoid arthritis Drug: The effectiveness of Xeljanz in rheumatoid arthritis patients



Primary Outcome Measures :
  1. Change from baseline of clinical evaluation in rheumatoid arthritis [ Time Frame: Every month ]
    DAS28, SDAI, Blood testing, Plain radiograph, and Ultrasound will be performed.


Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Every month ]


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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Rheumatoid arthritis

Exclusion Criteria:

  • Other connective tissue disease

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): NCT02157012


Contacts
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Contact: Yukio Nakamura, MD, PhD yxn14@aol.jp

Locations
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Japan
Yukio Nakamura Recruiting
Matsumoto, Nagano, Japan, 3908621
Contact: Yukio Nakamura, MD, PhD       yxn14@aol.jp   
Sponsors and Collaborators
Shinshu University
Showa Inan General Hospital

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Responsible Party: Yukio Nakamura, Assistant Professor, Shinshu University
ClinicalTrials.gov Identifier: NCT02157012     History of Changes
Other Study ID Numbers: Xeljanz2014
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018

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