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Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation

NCT03100253 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2022-09-19

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Mario Negri Institute for Pharmacological Research

    lead OTHER

Principal Investigators

  • Mauro Galeazzi · Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2021-12-01
Completion
2021-12-31

Countries

  • Italy

Study Locations

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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 NCT03100253 on ClinicalTrials.gov