NCT02157012

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started May 2014

Longer than P75 for phase_4 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

7.9 years

First QC Date

June 1, 2014

Last Update Submit

September 20, 2021

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Change from baseline of clinical evaluation in rheumatoid arthritis

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

    Every month

Secondary Outcomes (1)

  • Number of participants with adverse events

    Every month

Study Arms (1)

The condition of rheumatoid arthritis

EXPERIMENTAL
Drug: The effectiveness of Xeljanz in rheumatoid arthritis patients

Interventions

The effectiveness of Xeljanz in rheumatoid arthritis patientsDRUG
The condition of rheumatoid arthritis

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rheumatoid arthritis

You may not qualify if:

  • Other connective tissue disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yukio Nakamura

Matsumoto, Nagano, 3908621, Japan

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Yukio Nakamura, MD, PhD

CONTACT

yxn14@aol.jp

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 1, 2014

First Posted

June 5, 2014

Study Start

May 1, 2014

Primary Completion

April 1, 2022

Study Completion

March 1, 2025

Last Updated

September 21, 2021

Record last verified: 2021-09

Locations

JP(1)