Efficacy and Safety of Selective JAK 1 Inhibitor Filgotinib in Active Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate

Last updated: October 23, 2021
Sponsor: Atsushi Kawakami
Overall Status: Active - Recruiting

Phase

3

Condition

Dermatomyositis (Connective Tissue Disease)

Bone Diseases

Arthritis And Arthritic Pain

Treatment

N/A

Clinical Study ID

NCT05090410
CRB20_026
  • Ages > 20
  • All Genders

Study Summary

The administration of Janus kinase (JAK) inhibitors as well as biological disease-modifying anti-rheumatic drugs has dramatically improved even the clinical outcomes in rheumatoid arthritis (RA) patients with inadequate response to methotrexate (MTX). The dysregulation of JAK-signal transducer and activator of transcription (STAT) pathways via overproduction of cytokines, such as interleukin-6 (IL-6) is involved in the pathogenesis of RA. Filgotinib is a selective JAK1 inhibitor to be approved for use in RA. Filgotinib is effective in suppressing disease activity and preventing the progression of joint destruction due to inhibition of the JAK-STAT pathway. IL-6 inhibitors such as tocilizumab also inhibit the JAK-STAT pathways due to inhibition of IL-6 signaling. We will evaluate whether the effectiveness and safety of filgotinib monotherapy is non-inferior to those of tocilizumab monotherapy in RA patients with inadequate response to MTX.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients must meet all of the following requirements to be considered for entry intothe study:
  1. ≥20 years old
  2. with the diagnosis of RA based on the ACR/EULAR 2010 RA Classification Criteria
  3. with at least moderate disease activity defined as a DAS28-ESR ≥3.2 at theeligibility evaluation
  4. treated with MTX for ≥8 weeks prior to the providing consent, including 4 weeksor more at the same doses of 8 to 16 mg per week (stable doses of <8 mg per weekare allowed only in the presence of intolerance to higher doses)
  5. ability and willingness to provide written informed consent and comply with therequirements of the study protocol

Exclusion

Exclusion Criteria:

  • The exclusion criteria are as follows:
  1. concurrent use of a corticosteroid equivalent to >5 mg/day of prednisolone
  2. applicable an item for the contraindication of filgotinib or tocilizumab
  3. a previous use of a JAK inhibitor or IL-6 inhibitor
  4. treatment with a corticosteroid and csDMARD and change of dose within 4 weeksprior to the providing consent
  5. treatment with a biologic DMARD or a biosimilar DMARD (ie, infliximab, biosimilarof infliximab, adalimumab, biosimilar of adalimumab, golimumab, certolizumabpegol or abatacept) within 8 weeks prior to the providing consent
  6. treatment with a TNF inhibitor (ie, etanercept or biosimilar of etanercept)within 4 weeks prior to the providing consent
  7. use of a prohibited drug or therapy, other than the agents noted above, within 4weeks prior to the providing consent
  8. a complication causing musculoskeletal disorders other than RA (ie, ankylosingspondyloarthritis, reactive arthritis, psoriatic arthritis, crystal-inducedarthritis, systemic lupus erythematosus, systemic scleroderma, inflammatorymyopathy, or mixed connective tissue disease)
  9. current pregnancy, breastfeeding, or noncompliant with a medically approvedcontraceptive regimen during and 12 months after the study period
  10. inappropriateness for inclusion in this study as determined by the investigator

Study Design

Total Participants: 400
Study Start date:
March 03, 2021
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • Nagasaki University Hospital

    Nagasaki, 852-8501
    Japan

    Active - Recruiting

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