NCT03784261

Brief Summary

The aim of this study is to examine the efficacy and adverse events in the following 3 groups in rheumatoid arthritis patients:

  1. 1.Sarilumab treatment for 12 months
  2. 2.Tocilizmab treatment for 12 months
  3. 3.Abatacept treatment for 12 months

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
90

participants targeted

Target at P25-P50 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Dec 2018

Longer than P75 for phase_2 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

First Submitted

Initial submission to the registry

December 17, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

December 17, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2024

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

4 years

First QC Date

December 17, 2018

Last Update Submit

September 20, 2021

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline Values of DAS28-CRP

    Assessment of efficacy in rheumatoid arthritis patients for 1 year treated by salirumab (N=30), tocilizumab (N=30), or abatacept (N=30).

    Baseline and 1 year

  • Assessment of adverse event in rheumatoid arthritis patients for 1 year treated by salirumab (N=30), tocilizumab (N=30), or abatacept (N=30).

    at 1 year

Study Arms (3)

SAR, usually subucutaneous injection every 2 weeks

ACTIVE COMPARATOR
Drug: Drug: "Salirumab"Drug: Drug: "Tocilizmab"Drug: Drug: "Abatacept"

TCZ, usually subucutaneous injection every 2 weeks

ACTIVE COMPARATOR
Drug: Drug: "Salirumab"Drug: Drug: "Tocilizmab"Drug: Drug: "Abatacept"

ABT, usually subucutaneous injection every week

ACTIVE COMPARATOR
Drug: Drug: "Salirumab"Drug: Drug: "Tocilizmab"Drug: Drug: "Abatacept"

Interventions

Drug: "Salirumab"DRUG

To examine the effects of salirumab in RA patients

ABT, usually subucutaneous injection every weekSAR, usually subucutaneous injection every 2 weeksTCZ, usually subucutaneous injection every 2 weeks
Drug: "Tocilizmab"DRUG

To examine the effects of tocilizmab in RA patients

ABT, usually subucutaneous injection every weekSAR, usually subucutaneous injection every 2 weeksTCZ, usually subucutaneous injection every 2 weeks
Drug: "Abatacept"DRUG

To examine the effects of abatacept in RA patients

ABT, usually subucutaneous injection every weekSAR, usually subucutaneous injection every 2 weeksTCZ, usually subucutaneous injection every 2 weeks

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ・RA patients

You may not qualify if:

  • Not RA patients
  • RA patients who are allergic to the drugs, refused to do this research, or who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yukio Nakamura

Matsumoto, Nagano, 3908621, Japan

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ImmunoconjugatesAntibodiesImmunoglobulinsSerum GlobulinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsGlobulins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

December 17, 2018

First Posted

December 21, 2018

Study Start

December 17, 2018

Primary Completion

December 16, 2022

Study Completion

December 16, 2024

Last Updated

September 21, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)