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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Spondylitis, Ankylosing

In brief

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.

Key facts

Study ID

NCT01209702

Run by

Hoffmann-La Roche

People needed

306

Starts

2010-09-01

Expected to finish

2011-12-01

Last updated by the study team

2013-02-11

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• Traditional disease-modifying anti-rheumatic drugs (DMARDs) must be withdrawn for at least 4 weeks prior to baseline (methotrexate, sulfasalazine and hydroxychloroquine or chloroquine may be allowed if at stable dose for at least 4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

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
• 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

Where it is running

• Study site — Aventura, Florida, United States
• Study site — Orlando, 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 — Cumberland, Maryland, United States
• Study site — Saint Claire Shores, Michigan, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Greensboro, North Carolina, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Hickory Grove, South Carolina, United States
• Study site — Houston, Texas, United States
• Study site — Adelaide, Australia
• Study site — Heidelberg, Australia
• Study site — Hobart, Australia
• Study site — Malvern East, Australia
• Study site — Maroochydore, Australia
• Study site — Sydney, Australia
• Study site — Woodville, Australia
• Study site — Brussels, Belgium
• Study site — Kortrijk, Belgium
• Study site — Liège, Belgium
• Study site — Huntington Beach, California, United States

Full record on ClinicalTrials.gov

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