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COMPLETED Phase 3

Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission

NCT02373813 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

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

Study Locations (20)

California

  • Research Site — Escondido
  • Research Site — Fontana
  • Research Site — Hemet
  • Research Site — Huntington Beach
  • Research Site — La Jolla
  • Research Site — Murrieta
  • Research Site — Orange
  • Research Site — Sacramento
  • Research Site — Santa Maria
  • Research Site — Torrance
  • Research Site — Tustin
  • Research Site — Victorville
  • Research Site — West Hills

Arizona

  • Research Site — Glendale
  • Research Site — Mesa
  • Research Site — Phoenix
  • Research Site — Scottsdale

Alabama

  • Research Site — Birmingham
  • Research Site — Birmingham
  • Research Site — Huntsville

Trial Details

FieldValue
Enrollment Target 371 participants
Start Date 2015-02-20
Est. Completion 2019-12-06
Phase Phase 3

Sponsor

Amgen

266 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02373813

The ClinicalTrials.gov registry entry for NCT02373813 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 371 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 5 interventions — of which etanercept pre-filled syringe subcutaneous injection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02373813 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02373813 about?

NCT02373813 is a clinical study titled "Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission". 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-blin...

What is the current status of trial NCT02373813?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 371 participants. The study started on 2015-02-20. Estimated completion is 2019-12-06.

What conditions does trial NCT02373813 study?

This clinical trial studies the following conditions: Rheumatoid Arthritis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02373813?

The interventions under investigation include: etanercept pre-filled syringe subcutaneous injection (DRUG), Oral methotrexate (DRUG), Placebo for etanercept subcutaneous injection (DRUG), Placebo for methotrexate (DRUG), Folic acid (non-investigational product) (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02373813?

This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02373813 being conducted?

This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial