NCT03737708

A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA)

Compare Efficacy and Safety Between Biologics + Methotrexate (MTX) vs Biologics + Tacrolimus (TAC) (Switched From Biologics + Methotrexate (MTX)) in the Patients With Rheumatoid Arthritis (RA): Randomized, Interventional, Open, Active Controlled, Parallel Group, Multicenter-designed, Phase 4 Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Astellas Pharma Korea, Inc. · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy of Biologics + Methotrexate with Biologics + Tacrolimus measured by the disease activity score 28 (DAS28) erythrocyte sedimentation rate (ESR) and the American College of Rheumatology (ACR) scores. The study will also assess the safety of the combinations.

Detailed description

This study will include 4-weeks screening and a 12-week open-label treatment period.The participants in this study will visit the center five (5) times over the study period.

Conditions

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
DRUG	tacrolimus	Administered orally
DRUG	methotrexate	Administered orally
BIOLOGICAL	adalimumab	Administered as subcutaneous injection
BIOLOGICAL	tocilizumab	Administered by intravenous injection
BIOLOGICAL	abatacept	Administered by intravenous injection

Timeline

• Start date: 2019-02-13
• Primary completion: 2020-06-16
• Completion: 2020-06-16
• First posted: 2018-11-09
• Last updated: 2024-10-31

Locations

10 sites across 1 country: South Korea