Evaluation of a Protocol for Dose Reduction in Patients With Spondylarthropathies and Clinical Remission With Anti-TNF

Phase 4 Completed 120 enrolled Spanish Clinical Pharmacology Society Spanish reumatology Society · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to demonstrate that patients with Spondylarthropathies in remission under antiTNF therapy, can maintain the remission with a maintenance dose inferior to the currently recommended dose schedule.

Timeline

Start: 2012-07
Primary completion: 2015-04
Completion: 2015-09

Outcome

Met primary endpoint

paper dose reduction is non-inferior to full TNF inhibitor doses to maintain LDA after 1 year. PMID 30621746 ↗

Publications

Gratacos J, Pontes C, Juanola X, Sanz J, Torres F, Avendano C, Vallano A, Calvo G, de Miguel E, Sanmarti R; REDES-TNF investigators. Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis. Arthritis Res Ther. 2019 Jan 8;21(1):11. doi: 10.1186/s13075-018-1772-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Adalimumab	Monoclonal antibody	40 mg	—
Subject	Etanercept	Protein / enzyme biologic	25 mg	—
Subject	Etanercept	Protein / enzyme biologic	50 mg	—
Subject	Golimumab	Monoclonal antibody	50 mg	—
Subject	Infliximab	Monoclonal antibody	3 mg/kg	—
Subject	Infliximab	Monoclonal antibody	5 mg/kg	—