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A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment With NSAIDs

NCT01209702 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2013-02-11

Study results available
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Summary

This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with ankylosing spondylitis (AS) who have failed treatment with non-steroidal anti-inflammatory drugs and are naïve to tumor necrsos factor (TNF) antagonist therapy. In Part 1 of the study, patients will be randomized to receive either RoActemra/Actemra 8 mg/kg intravenously (IV) or placebo every 4 weeks for 12 weeks. In Part 2, patients will be randomized to receive RoActemra at either 8 mg/kg or 4 mg/kg IV or placebo every 4 weeks for 24 weeks. The double-blind treatment period will be followed by open-label treatment with RoActemra/Actemra 8 mg/kg iv every 4 weeks until Week 208 for all patients. Anticipated time on study treatment is 208 weeks.

Conditions

  • Spondylitis, Ankylosing

Interventions

BIOLOGICAL

tocilizumab

Administered intravenously (iv) every 4 weeks

DRUG

Placebo

Placebo to tocilizumab administered intravenously every 4 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-05-31
Completion
2011-12-31

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Germany
  • India
  • Italy
  • Lithuania
  • Poland
  • Russia
  • Slovakia
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01209702 on ClinicalTrials.gov