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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

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ClinicalTrials.gov Identifier: NCT01209689
Recruitment Status : Terminated (Clinical development program terminated due to failure to achieve efficacy)
First Posted : September 27, 2010
Results First Posted : January 17, 2013
Last Update Posted : January 17, 2013
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Spondylitis, Ankylosing Drug: Tocilizumab Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : October 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Arm Intervention/treatment
Experimental: Tocilizumab 4 mg/kg
Patients received tocilizumab 4 mg/kg intravenously every 4 weeks for 24 weeks.
Drug: Tocilizumab
Other Names:
  • RoActemra
  • Actemra

Experimental: Tocilizumab 8 mg/kg
Patients received tocilizumab 8 mg/kg intravenously every 4 weeks for 24 weeks.
Drug: Tocilizumab
Other Names:
  • RoActemra
  • Actemra

Placebo Comparator: Placebo
Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
Drug: Placebo

Primary Outcome Measures :
  1. Percentage of ASsessment in Ankylosing Spondylitis 20 (ASAS20) Responders at Week 12 [ Time Frame: Baseline to Week 12 ]
    ASAS20 was defined as an improvement of ≥ 20% and an absolute improvement of ≥ 10 units on a 0-100 visual analog scale (VAS) from Baseline to Week 12 in 3 of 4 domains: 1-Patient global assessment (with extremes labelled none and severe), 2-Pain assessment (average total and nocturnal pain scores with extremes labelled no pain and most severe pain), 3-Function (represented by the Bath Ankylosing Spondylitis (BAS) Functional Index [BASFI] average of 10 questions regarding ability to perform specific tasks with extremes labelled easy and impossible), and 4-Inflammation (average of the last 2 questions on the 6-question BAS Disease Activity Index [BASDAI] concerning morning stiffness intensity with extremes labelled none and very severe and duration between 0 and 2 or more hours); and the absence of deterioration (of at least 20% and absolute change of at least 10 units on a 0-100 mm scale) in the remaining domain.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients ≥ 18 years of age.
  • Ankylosing spondylitis as defined by the modified New York criteria for ≥ 3 months prior to baseline.
  • Active disease at screening and baseline (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] ≥ 4.0, spinal pain visual analog scale [VAS] ≥ 40).
  • Inadequate response or intolerant to 1 or more previous non-steroidal anti-inflammatory drugs (NSAIDs).
  • Inadequate response to treatment with etanercept, infliximab, adalimumab, or golimumab because of inadequate efficacy.
  • Tumor necrosis factor (TNF) antagonist therapy must have been discontinued at least 8 weeks prior to baseline (etanercept 4 weeks).
  • Traditional disease-modifying anti-rheumatic drugs (DMARDs) must be withdrawn for at least 4 weeks prior to baseline (methotrexate, sulfasalazine, and hydroxychloroquine or chloroquine may be allowed if at stable dose for at least 4 weeks prior to baseline).
  • Oral corticosteroids (≥ 10 mg/day prednisone or equivalent) and NSAIDs/cyclooxygenase-2 [COX-2] inhibitors must be at stable dose for at least 4 weeks prior to baseline.

Exclusion Criteria:

  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after randomization.
  • Total ankylosis of spine (as determined by investigator).
  • Inflammatory rheumatic disease other than ankylosing spondylitis.
  • Active, acute uveitis at baseline.
  • Previous treatment with tocilizumab.
  • Intra-articular or tendon injections or parenteral corticosteroids within 4 weeks prior to screening.
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
  • Active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infection.
  • History of or currently active primary or secondary immunodeficiency.
  • Body weight > 150 kg.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01209689

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Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01209689    
Other Study ID Numbers: WA22908
First Posted: September 27, 2010    Key Record Dates
Results First Posted: January 17, 2013
Last Update Posted: January 17, 2013
Last Verified: December 2012
Additional relevant MeSH terms:
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Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases