deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 2-arm NCT03355872

A Randomised, Double-blind, Phase I/II Study to Evaluate the PK, PD, Safety, and Efficacy Between HLX01 and Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Treatment With DMARDs

Sponsor: Shanghai Henlius Biotech

Interventions HLX01
Updated 7 times since 2017 Last updated: May 4, 2022 Started: Feb 29, 2016 Primary completion: Aug 31, 2018 Completion: Aug 31, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1/PHASE2 trial investigates Rheumatoid Arthritis and is currently completed. Shanghai Henlius Biotech leads this study, which shows 7 recorded versions since 2016 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Nov 2018 · 5 months · monthly snapshotActive Not Recruiting~Nov 2018 – ~Jan 2021 · 26 months · monthly snapshotCompleted~Jan 2021 – ~Jun 2022 · 17 months · monthly snapshotCompleted~Jun 2022 – ~Jul 2024 · 25 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 23 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

  3. Jun 2022 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

  4. Jan 2021 — Jun 2022 [monthly]

    Completed PHASE1_PHASE2

  5. Nov 2018 — Jan 2021 [monthly]

    Completed PHASE1_PHASE2

    Status: Active Not RecruitingCompleted

Show 2 earlier versions
  1. Jun 2018 — Nov 2018 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  2. Dec 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    First recorded

Feb 2016

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Shanghai Henlius Biotech
Data source: Shanghai Henlius Biotech

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

Study Locations

No location information available.