A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment With NSAIDs
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: tocilizumab; Placebo
Intervention description: Administered intravenously (iv) every 4 weeks; Placebo to tocilizumab administered intravenously every 4 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 306.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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)

          -  Traditional disease-modifying anti-rheumatic drugs (DMARDs) must be withdrawn for at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/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

          -  Treatment with tumor necrosis factor (TNF) antagonist therapy at any time prior to
             baseline

          -  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