NCT03100253

Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation

Open-label, Randomized Controlled Trial Comparing Tocilizumab to Anti-TNF Treatment and Discovery of Biomarkers for Treatment Selection in Rheumatoid Arthritis Patients With Inadequate Response to a First Anti-TNF

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Mario Negri Institute for Pharmacological Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy of switching to a different molecular target (from TNF to IL6) versus cycling to a second TNF inhibitor in patients with active RA, who have not adequately responded to a previous treatment with a first anti-TNF.

Detailed description

New drugs for the treatment of rheumatoid arthritis (RA) with action on specific molecular target (e.g. anti-TNF) have improved the prognosis of patients with an inadequate response to conventional therapy such as methotrexate (MTX). However, approximately 50% of patients treated with first-line anti-TNF discontinue treatment after two years due to ineffectiveness or adverse events. The second line treatment involves the use of another anti-TNF drug or switching to a different molecular target (anti-IL6, -CD20 or CTLA-4-Ig) in combination with MTX.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Tocilizumab	8 mg/kg i.v. every 4 weeks OR 162 mg s.c every seven days
DRUG	Etanercept	a. Etanercept if initial failure to monoclonal antibodies: infliximab, adalimumab, golimumab or certolizumab
DRUG	Infliximab	infliximab if initial failure to the receptor fusion protein, etanercept.
DRUG	Adalimumab	adalimumab if initial failure to the receptor fusion protein, etanercept.
DRUG	Golimumab	golimumab if initial failure to the receptor fusion protein, etanercept.
DRUG	Certolizumab Pegol	Certolizumab Pegol if initial failure to the receptor fusion protein, etanercept.

Timeline

• Start date: 2018-03-01
• Primary completion: 2021-12-01
• Completion: 2021-12-31
• First posted: 2017-04-04
• Last updated: 2022-09-19

Locations

22 sites across 1 country: Italy