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

Conditions

• Spondylitis, Ankylosing

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tocilizumab — DRUG
• Placebo — DRUG

Study Details

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 Dates

Start date

Oct 31, 2010

Status verified

Dec 2012

Primary completion

Dec 31, 2011

Completion

Dec 31, 2011

Study Design

Enrollment

113 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tocilizumab 4 mg/kg
  Patients received tocilizumab 4 mg/kg intravenously every 4 weeks for 24 weeks.
• Experimental: Tocilizumab 8 mg/kg
  Patients received tocilizumab 8 mg/kg intravenously every 4 weeks for 24 weeks.
• Placebo Comparator: Placebo
  Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.

Primary Outcome Measure

Percentage of ASsessment in Ankylosing Spondylitis 20 (ASAS20) Responders at Week 12 [ Time Frame: Baseline to Week 12 ]

Locations (19)

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  Recruiting · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Bethesda, Maryland