drugset / Trial / NCT03737708

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

NCT03737708

Phase 4 Completed 21 enrolled Astellas Pharma Inc
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2019-02-13
Primary completion
2020-06-16
Completion
2020-06-16

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methotrexate Small molecule Oral
Subject Tacrolimus Small molecule Oral
Background Abatacept Other / unclassified Intravenous
Background Adalimumab Monoclonal antibody Subcutaneous
Background Tocilizumab Monoclonal antibody Intravenous

Indications