Evaluation of the Condition of Rheumatoid Arthritis After Treatment

• Sponsor: Shinshu University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02157012
• Collaborator: Showa Inan General Hospital (Other)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 130
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• 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
• Actual Study Start Date: May 1, 2014
• Anticipated Primary Completion Date: Apr 1, 2022
• Anticipated Study Completion Date: Mar 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change from baseline of clinical evaluation in rheumatoid arthritis [Every month]

   DAS28, SDAI, Blood testing, Plain radiograph, and Ultrasound will be performed.

Secondary Outcome Measures

1. Number of participants with adverse events [Every month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Rheumatoid arthritis

Exclusion Criteria:

• Other connective tissue disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yukio Nakamura	Matsumoto	Nagano	Japan	3908621

Sponsors and Collaborators

• Shinshu University
• Showa Inan General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yukio Nakamura, Assistant Professor, Shinshu University
• ClinicalTrials.gov Identifier: NCT02157012
• Other Study ID Numbers: Xeljanz2014
• First Posted: Jun 5, 2014
• Last Update Posted: Sep 21, 2021
• Last Verified: Sep 1, 2021

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Tofacitinib

Study Results

No Results Posted as of Sep 21, 2021