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Evaluation of the Optimal MTX Dose as an Add-on Therapy to Adalimumab for RA Patients in Japan, South Korea and Taiwan

NCT03505008 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-03-06

Study results available
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Summary

This study will be conducted in Japan, South Korea and Taiwan to evaluate the optimal dosage of methotrexate (MTX) as an add-on therapy to adalimumab (ADA) in participants with rheumatoid arthritis (RA) who have not achieved remission by MTX monotherapy.

Conditions

Interventions

DRUG

Methotrexate

Route of Administration: Oral

DRUG

Adalimumab

Route of Administration: Subcutaneous

Sponsors & Collaborators

  • Eisai Co., Ltd.

    collaborator INDUSTRY

  • Keio University

    lead OTHER

Principal Investigators

  • Yuko Kaneko, MD, PhD · Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-18
Primary Completion
2021-05-11
Completion
2021-05-11

Countries

  • Japan
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03505008 on ClinicalTrials.gov