deltatrials
Terminated PHASE3 INTERVENTIONAL 3-arm NCT01198002

A Rheumatoid Arthritis Study in Participants on a Background Treatment of Methotrexate (FLEX M)

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate Therapy (FLEX M)

Sponsor: Eli Lilly and Company

Updated 9 times since 2017 Last updated: May 4, 2018 Started: Dec 31, 2010 Primary completion: Dec 31, 2012 Completion: Jan 31, 2014
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Terminated not based on safety concerns, but due to insufficient efficacy.

This PHASE3 trial investigates Rheumatoid Arthritis and is currently terminated or withdrawn. Eli Lilly and Company leads this study, which shows 9 recorded versions since 2010 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotTerminated~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotTerminated~Sep 2025 – present · 7 months · monthly snapshotTerminated~Jan 2026 – present · 3 months · monthly snapshotTerminated

Change History

9 versions recorded
  1. Jan 2026 — Present [monthly]

    Terminated PHASE3

  2. Sep 2025 — Present [monthly]

    Terminated PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  5. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE3

Show 4 earlier versions
  1. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE3

  2. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE3

    Status: CompletedTerminated

  3. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE3

  4. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE3

    First recorded

Dec 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Eli Lilly and Company
Data source: Eli Lilly and Company

For direct contact, visit the study record on ClinicalTrials.gov .