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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Spondylitis, Ankylosing

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Trial Information

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


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- Traditional disease-modifying anti-rheumatic drugs (DMARDs) must be withdrawn for at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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Percentage of ASsessment in Ankylosing Spondylitis 20 (ASAS20) Responders at Week 12

Outcome Description:

ASAS20 was defined as an improvement of ≥ 20% and an absolute improvement of ≥ 10 units on a 0-100 visual analog scale (VAS) from Baseline to Week 12 in 3 of 4 domains: 1-Patient global assessment (with extremes labelled none and severe), 2-Pain assessment (average total and nocturnal pain scores with extremes labelled no pain and most severe pain), 3-Function (represented by the Bath Ankylosing Spondylitis (BAS) Functional Index [BASFI] average of 10 questions regarding ability to perform specific tasks with extremes labelled easy and impossible), and 4-Inflammation (average of the last 2 questions on the 6-question BAS Disease Activity Index [BASDAI] concerning morning stiffness intensity with extremes labelled none and very severe and duration between 0 and 2 or more hours); and the absence of deterioration (of at least 20% and absolute change of at least 10 units on a 0-100 mm scale) in the remaining domain.

Outcome Time Frame:

Baseline to Week 12

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

WA22908

NCT ID:

NCT01209689

Start Date:

October 2010

Completion Date:

December 2011

Related Keywords:

  • Spondylitis, Ankylosing
  • Spondylitis
  • Spondylitis, Ankylosing

Name

Location

Albany, Georgia  31701
Fountain Valley, California  92708
Miami, Florida  33176
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
Flint, Michigan  48532
Kansas City, Kansas  66160
Hackensack, New Jersey  07601
Baltimore, Maryland  21287
Charlotte, North Carolina  
Coeur D'alene, Idaho  83814