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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Spondylitis, Ankylosing

In brief

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.

Key facts

Study ID

NCT01209689

Run by

Hoffmann-La Roche

People needed

113

Starts

2010-10-01

Expected to finish

2011-12-01

Last updated by the study team

2013-01-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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• Traditional disease-modifying anti-rheumatic drugs (DMARDs) must be withdrawn for at least 4 weeks prior to baseline (methotrexate, sulfasalazine, and hydroxychloroquine or chloroquine may be allowed if at stable dose for at least 4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.

You may not qualify if…

• 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.

Where it is running

• Study site — Aventura, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Decatur, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Wichita, Kansas, United States
• Study site — Hagerstown, Maryland, United States
• Study site — Saint Claire Shores, Michigan, United States
• Study site — Freehold, New Jersey, United States
• Study site — Asheville, North Carolina, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Greensboro, North Carolina, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Austin, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Heidelberg, Australia
• Study site — Hobart, Australia
• Study site — Sydney, Australia
• Study site — Woodville, Australia
• Study site — Brussels, Belgium
• Study site — Ghent, Belgium
• Study site — Huntington Beach, California, United States

Full record on ClinicalTrials.gov

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