Back to resultsEvaluation of the Condition of Rheumatoid Arthritis After Treatment
Primary Purpose
Rheumatoid Arthritis
Status
Recruiting
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
The effectiveness of Xeljanz in rheumatoid arthritis patients
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Rheumatoid arthritis
Exclusion Criteria:
- Other connective tissue disease
Sites / Locations
- Yukio NakamuraRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
The condition of rheumatoid arthritis
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline of clinical evaluation in rheumatoid arthritis
DAS28, SDAI, Blood testing, Plain radiograph, and Ultrasound will be performed.
Secondary Outcome Measures
Number of participants with adverse events
Full Information
NCT ID
NCT02157012
First Posted
June 1, 2014
Last Updated
September 20, 2021
Sponsor
Shinshu University
Collaborators
Showa Inan General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02157012
Brief Title
Evaluation of the Condition of Rheumatoid Arthritis After Treatment
Official Title
Evaluation of the Condition After Xeljanz Treatment in Rheumatoid Arthritis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 2014 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shinshu University
Collaborators
Showa Inan General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To examine the safety and effectiveness after Xeljanz treatment in rheumatoid arthritis patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The condition of rheumatoid arthritis
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
The effectiveness of Xeljanz in rheumatoid arthritis patients
Primary Outcome Measure Information:
Title
Change from baseline of clinical evaluation in rheumatoid arthritis
Description
DAS28, SDAI, Blood testing, Plain radiograph, and Ultrasound will be performed.
Time Frame
Every month
Secondary Outcome Measure Information:
Title
Number of participants with adverse events
Time Frame
Every month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Rheumatoid arthritis
Exclusion Criteria:
Other connective tissue disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yukio Nakamura, MD, PhD
Email
yxn14@aol.jp
Facility Information:
Facility Name
Yukio Nakamura
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
3908621
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yukio Nakamura, MD, PhD
Email
yxn14@aol.jp
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Condition of Rheumatoid Arthritis After Treatment
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