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A Study to Target the Type I IFN Receptor by Administrating Anifrolumab in RA Patients With a High IFN Signature (TarIFNiRA)

NCT03435601 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-03-02

No results posted yet for this study

Summary

A multicenter, randomised, double-blind, placebo-controlled Phase 2A/ proof-of-concept study to evaluate the efficacy and safety of an intravenous treatment regimen of 300 mg Anifrolumab versus placebo in patients with moderately to severely active RA who did not respond to biological disease-modifying anti-rheumatic drugs (bDMARDs) and who have a high type I IFN gene signature.

Conditions

Interventions

DRUG

Anifrolumab

IV Administration of Anifrolumab 300 mg every 4 weeks from week 0 to week 20 for a total of 6 doses. At week 24 patients will continue the current study for another 8 weeks to complete a 12-week safety follow-up after the last dose of investigational products (last dose of investigational product will be given at week 20). The total study duration could be up to approximately 36 weeks (including the screening period).

DRUG

Placebos

Placebo IV administration Q4W, a total of 6 doses At week 24 patients will continue the current study for another 8 weeks to complete a 12-week safety follow-up after the last dose of investigational products (last dose of investigational product will be given at week 20). The total study duration could be up to approximately 36 weeks (including the screening period).

Sponsors & Collaborators

  • Josef Smolen, Univ. Prof. Dr.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-18
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • Austria

Study Locations

More Related Trials

Entities

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 NCT03435601 on ClinicalTrials.gov