Evaluation of the Condition of Rheumatoid Arthritis After Treatment

September 20, 2021 updated by: Yukio Nakamura, Shinshu University

Evaluation of the Condition After Xeljanz Treatment in Rheumatoid Arthritis Patients

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
    • Nagano
      • Matsumoto, Nagano, Japan, 3908621
        • Recruiting
        • Yukio Nakamura
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Rheumatoid arthritis

Exclusion Criteria:

  • Other connective tissue disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The condition of rheumatoid arthritis
Drug: The effectiveness of Xeljanz in rheumatoid arthritis patients

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: Every month
Every month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shinshu University

Collaborators

Showa Inan General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

June 1, 2014

First Submitted That Met QC Criteria

June 3, 2014

First Posted (Estimate)

June 5, 2014

Study Record Updates

Last Update Posted (Actual)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Xeljanz2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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