NCT03011281

Brief Summary

The objectives of this single center, prospective, non-interventional inception cohort is to understand patient characteristics, general treatment patterns, effectiveness, and safety of Tofacitinib for rheumatoid arthritis patients in the real-world setting.

  1. 1.To evaluate the baseline characteristics of Korean RA patients treated with Tofacitinib
  2. 2.To evaluate the effectiveness and safety of Tofacitinib in clinical practice in Korean RA patients.
  3. 3.To further evaluate safety, effectiveness and demographic characteristics of the patients treated with Tofacitinib matched with and compared to biologic DMARDs from the BIOPSY registry database.

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
378

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

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

September 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

June 25, 2020

Status Verified

June 1, 2020

Enrollment Period

4.3 years

First QC Date

December 30, 2016

Last Update Submit

June 23, 2020

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • DAS28-ESR (erythrocyte sedimentation rate) remission (DAS28 < 2.6) rate (%)

    5 years

Secondary Outcomes (11)

  • Assessment of efficacy with DAS28 (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP))

    5 years

  • Assessment of safety based on adverse events that occur during 5 years of patient monitoring.

    5 years

  • Assessment of adherence with Patient-reported Adherence, and Medication Possession Ratio (MPR) at 24, 48, 72, 96, 120, 144, 168, 192, 216 and 240 weeks of clinical visit.

    5 years

  • Assessment of Quality of life by European Quality of Life-5 Dimensions (EQ-5D)

    5 years

  • Global Health assessment using Visual Analogue Scale (VAS)

    5 years

  • +6 more secondary outcomes

Study Arms (1)

RA patients who start Tofacitinib

Korean RA patients who start Tofacitinib with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate or biologics.

Drug: Tofacitinib

Interventions

TofacitinibDRUG
Also known as: Xeljanz
RA patients who start Tofacitinib

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Korean RA patients who start Tofacitinib with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate or biologics

You may qualify if:

  • A. Patients who provide a written informed consent form of participating in this study.
  • B. Patients who are more than 19 years old. C. Patients with moderately to severely active rheumatoid arthritis as defined per EULAR guidelines, who have had an inadequate response or are intolerant to methotrexate.

You may not qualify if:

  • A. Patients who do not provide a written informed consent form of participating in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanyang University

Seoul, 04763, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Hemoglobin Hematocrit WBC Platelet count ESR CRP ALT AST ALP BUN Creatinine Bilirubin Urinalysis Total Cholesterol HDL (Calculated) LDL TG Rheumatoid factor(RF) Anti-nuclear antibodies(ANA) Anti-CCP HbA1c

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

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

Study Officials

  • Yoon-Kyoung Sung, MD, PhD, MPH

    Hanyang University Hospital for Rheumatic Diseases

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoon-Kyoung Sung, MD, PhD, MPH

CONTACT

82-2-2290-9250sungyk@hanyang.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 30, 2016

First Posted

January 5, 2017

Study Start

September 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

June 25, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)