RABIOPRED - a Validation Study of Theranostic Test to PREDict Treatment Response of Anti-TNFα BIologicals in Rheumatoid Arthritis

Sponsor
TcLand Expression S.A.
Study ID
NCT03016260
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Infliximab — BIOLOGICAL
    Anti-TNF alpha originator
  • Adalimumab — BIOLOGICAL
    Anti-TNF alpha originator
  • Etanercept — BIOLOGICAL
    Anti-TNF alpha originator
  • Golimumab — BIOLOGICAL
    Anti-TNF alpha originator
  • Certolizumab Pegol — BIOLOGICAL
    Anti-TNF alpha originator
  • Infliximab biosimilar — BIOLOGICAL
    Anti-TNF alpha Infliximab biosimilars
  • Etanercept biosimilar — BIOLOGICAL
    Anti-TNF alpha Etanercept biosimilar
  • Infliximab biosimilar — BIOLOGICAL
    Anti-TNF alpha Infliximab biosimilar

Study Details

RABIOPRED is an in vitro non-invasive blood test, which aims to identify patients with rheumatoid arthritis (RA) who are not likely to respond to anti-TNFα and methotrexate combination therapy.

Key Dates

Start date
Dec 31, 2016
Status verified
Dec 2019
Primary completion
Dec 20, 2019
Completion
Dec 20, 2019

Study Design

Enrollment
250 participants (actual)

Arms

  • Arm: Infliximab (Remicade®)
  • Arm: Adalimumab (Humira®)
  • Arm: Etanercept (Enbrel®)
  • Arm: Golimumab (Simponi®)
  • Arm: Certolizumab Pegol (Cimzia®)
  • Arm: Infliximab biosimilar (Remsima®/ Inflectra®)
  • Arm: Etanercept biosimilar (Benepali®)
  • Arm: Infliximab biosimilar (Flixabi®)

Primary Outcome Measure

EULAR response criteria [ Time Frame: 13th week (+/- 7 days) ]

Related Studies