deltatrials
Terminated PHASE3 INTERVENTIONAL 2-arm NCT00603525

Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to TNF-α Antagonist Therapy

A Double-blind, Randomized, Placebo Controlled, Parallel Group, Multi-center, Phase III Trial of Ofatumumab Investigating Clinical Efficacy in Patients With Active Rheumatoid Arthritis Who Have Previously Had an Inadequate Response to One or More TNF Antagonist Therapies

Sponsor: GlaxoSmithKline

Updated 11 times since 2017 Last updated: May 22, 2014 Started: Jan 31, 2008 Primary completion: Mar 31, 2011 Completion: Jul 31, 2013
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Ofatumumab IV trials in RA were prematurely terminated because GSK refocused clinical development of autoimmune indications on the subcutaneous delivery.

This PHASE3 trial investigates Arthritis, Rheumatoid and is currently terminated or withdrawn. GlaxoSmithKline leads this study, which shows 11 recorded versions since 2008 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

This study consist of a double-blind, placebo controlled, and parallel group part with eligible patients enrolled into a 24 week Double-Blind Period, and randomized in a 1:1 ratio to receive either ofatumumab or placebo in addition to their background methotrexate treatment. Patients who complete the 24 week Double-blind Period without receiving rescue DMARD treatment will then be eligible to proceed into the 120 week Open-label Period to receive repeat treatment courses with ofatumumab. In the Open-label Period ofatumumab treatment courses will be given at individualized time intervals only if a clinical response has been achieved following the previous treatment course, and followed by a subsequent worsening in disease activity. Patients who have completed the Open-label Period or have been withdrawn will then enter a maximum 2 year Follow-up Period, or until there B-cells return to normal or to baseline levels, whichever occurs earlier

This study consist of a double-blind, placebo controlled, and parallel group part with eligible patients enrolled into a 24 week Double-Blind Period, and randomized in a 1:1 ratio to receive either ofatumumab or placebo in addition to their background methotrexate treatment. Patients who complete the 24 week Double-blind Period without receiving rescue DMARD treatment will then be eligible to proceed into the 120 week Open-label Period to receive repeat treatment courses with ofatumumab. In the Open-label Period ofatumumab treatment courses will be given at individualized time intervals only if a clinical response has been achieved following the previous treatment course, and followed by a subsequent worsening in disease activity.

Patients who have completed the Open-label Period or have been withdrawn will then enter a maximum 2 year Follow-up Period, or until there B-cells return to normal or to baseline levels, whichever occurs earlier

Status Flow

~Jan 2017 – ~Aug 2017 · 7 months · monthly snapshotTerminated~Aug 2017 – ~May 2018 · 9 months · monthly snapshotTerminated~May 2018 – ~Jun 2018 · 31 days · monthly snapshotTerminated~Jun 2018 – ~Nov 2020 · 29 months · monthly snapshotTerminated~Nov 2020 – ~Jan 2021 · 2 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

11 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 6 earlier versions
  1. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE3

  2. Nov 2020 — Jan 2021 [monthly]

    Terminated PHASE3

  3. Jun 2018 — Nov 2020 [monthly]

    Terminated PHASE3

  4. May 2018 — Jun 2018 [monthly]

    Terminated PHASE3

  5. Aug 2017 — May 2018 [monthly]

    Terminated PHASE3

  6. Jan 2017 — Aug 2017 [monthly]

    Terminated PHASE3

    First recorded

Jan 2008

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • GlaxoSmithKline
Data source: GlaxoSmithKline

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