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Your journey
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3Review
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More info
You can access this
clinical trial
if you have
Rheumatoid Arthritis
and you are
over 18
years old
Phase
3
This is a trial in the final phase before the treatment is released on the market.
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The purpose

The purpose of this study is to evaluate the efficacy of etanercept monotherapy compared to methotrexate monotherapy on maintenance of remission in participants with rheumatoid arthritis (RA) who were on etanercept plus methotrexate therapy. This is a multicenter, randomized withdrawal, double-blind controlled study in participants with rheumatoid arthritis on etanercept plus methotrexate therapy who are in very good disease control for 6 months prior to study entry. The study will consist of a 30-day screening period, a 24-week open label run-in period, a 48-week double-blind treatment period and a 30-day safety follow-up period.

Provided treatments

  • Drug: etanercept pre-filled syringe subcutaneous injection
  • Drug: Oral methotrexate
  • Drug: Placebo for etanercept subcutaneous injection
  • Drug: Placebo for methotrexate
  • : Folic acid (non-investigational product)

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Results
Tris trial is registered with FDA with number: NCT02373813. The sponsor of the trial is Amgen and it is looking for 371 volunteers for the current phase.
Official trial title:
A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis