Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Clinical development program terminated due to failure to achieve efficacy
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Spondylitis, Ankylosing | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Tocilizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Tocilizumab 4 mg/kg
- description
- Patients received tocilizumab 4 mg/kg intravenously every 4 weeks for 24 weeks.
- interventionNames
- Drug: Tocilizumab
- type
- EXPERIMENTAL
- label
- Tocilizumab 8 mg/kg
- description
- Patients received tocilizumab 8 mg/kg intravenously every 4 weeks for 24 weeks.
- interventionNames
- Drug: Tocilizumab
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDSieper J, Porter-Brown B, Thompson L, Harari O, Dougados M. Assessment of short-term symptomatic efficacy of tocilizumab in ankylosing spondylitis: results of randomised, placebo-controlled trials. Ann Rheum Dis. 2014 Jan;73(1):95-100. doi: 10.1136/annrheumdis-2013-203559. Epub 2013 Jun 13. PMID 23765873