Completed PHASE3 INTERVENTIONAL 2-arm NCT04135508

A Phase III Study Evaluate the Efficacy and Safety of BAT1406 and Humira

A Multicenter, Randomized, Double-Blind, Phase III Clinical Trial Parallel Controlled With Humira to Evaluate the Efficacy and Safety of BAT1406 Injection in the Treatment of Ankylosing Spondylitis

Sponsor: Bio-Thera Solutions

Conditions Ankylosing Spondylitis

Interventions BAT1406 Humira

Updated 4 times since 2019 Last updated: Oct 21, 2019 Started: Dec 13, 2016 Primary completion: Mar 22, 2018 Completion: May 31, 2018

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04135508, this PHASE3 trial focuses on Ankylosing Spondylitis and remains completed. Sponsored by Bio-Thera Solutions, it has been updated 4 times since 2016, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

4 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Nov 2019 — Jan 2021 [monthly]

Completed PHASE3

First recorded

Dec 2016

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Bio-Thera Solutions

Data source: Bio-Thera Solutions

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

Study Locations

No location information available.