Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation

Sponsor
Mario Negri Institute for Pharmacological Research
Study ID
NCT03100253
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 1, 2018
Status verified
Sep 2022
Primary completion
Dec 1, 2021
Completion
Dec 31, 2021

Study Design

Enrollment
208 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: "Switching" strategy
    Tocilizumab \[RoActemra®\] \[ATC: L04AC07\] 8 mg/kg i.v. every 4 weeks OR 162 mg s.c every seven days
  • Active Comparator: "Cycling" strategy
    1. Etanercept if initial failure to monoclonal antibodies: infliximab, adalimumab, golimumab or certolizumab OR 2. Infliximab, adalimumab, golimumab or certolizumab if initial failure to the receptor fusion protein, etanercept.

Primary Outcome Measure

Proportion of patients with good EULAR [ Time Frame: 24 weeks ]

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