A Study of Tocilizumab (RoActemra/Actemra) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous Tumor Necrosis Factor (TNF) Antagonist Therapy

ClinicalTrials.gov ID: NCT01209689

Public ClinicalTrials.gov record NCT01209689. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 25, 2026, 1:14 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-blind, Parallel Group Placebo-controlled Study of the Safety and Reduction of Signs and Symptoms During Treatment With Tocilizumab (TCZ) Versus Placebo in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous TNF Antagonist Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of tocilizumab (RoActemra/Actemra) in patients with ankylosing spondylitis (AS) who had an inadequate response to previous tumor necrosis factor (TNF) antagonist therapy. Patients were randomized to receive tocilizumab at a dose of either 8 mg/kg or 4 mg/kg intravenously (iv) or placebo every 4 weeks for 24 weeks. The double-blind treatment period was followed by open-label treatment with tocilizumab 8 mg/kg iv every 4 weeks until Week 104 for all patients. This study and all further clinical development of tocilizumab AS was halted after a review of 12-week data from Study NA22823, a randomized double-blind, placebo-controlled study in TNF antagonist naïve AS patients, failed to demonstrate efficacy.

Study identification

NCT ID: NCT01209689
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 3
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 113 participants

Conditions and interventions

Conditions

Spondylitis, Ankylosing

Interventions

Tocilizumab Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 2010 (Type not available)
Primary completion: Dec 2011 (Actual)
Completion: Dec 2011 (Actual)
Last update posted: Jan 17, 2013

2010 – 2011

United States locations

U.S. sites: 19
U.S. states: 11
U.S. cities: 19

Facility	City	State	ZIP	Site status
Not listed	Huntington Beach	California	92646	—
Not listed	Aventura	Florida	33180	—
Not listed	Miami	Florida	33169	—
Not listed	Orlando	Florida	32804	—
Not listed	Tampa	Florida	33609	—
Not listed	Atlanta	Georgia	30342	—
Not listed	Decatur	Georgia	30033	—
Not listed	Marietta	Georgia	30060	—
Not listed	Idaho Falls	Idaho	83404	—
Not listed	Wichita	Kansas	67207	—
Not listed	Hagerstown	Maryland	21740	—
Not listed	Saint Claire Shores	Michigan	48081	—
Not listed	Freehold	New Jersey	07728	—
Not listed	Asheville	North Carolina	28803	—
Not listed	Charlotte	North Carolina	28210	—
Not listed	Greensboro	North Carolina	27408	—
Not listed	Duncansville	Pennsylvania	16635	—
Not listed	Austin	Texas	78731	—
Not listed	Houston	Texas	77004	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 121 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01209689, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jan 17, 2013 · Synced Oct 25, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01209689 live on ClinicalTrials.gov.

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