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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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Spondylitis, Ankylosing

Intervention: Tocilizumab (Drug); Placebo (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

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.

Clinical Details

Official title: 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

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

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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).

- 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.

Locations and Contacts

Heidelberg 3084, Australia

Hobart 7000, Australia

Sydney 2050, Australia

Woodville 5011, Australia

Bruxelles 1200, Belgium

Gent 9000, Belgium

Kortrijk 8500, Belgium

Liege 4000, Belgium

Yvoir 5530, Belgium

Cuiabá 78025-000, Brazil

Goiania 74110-120, Brazil

Sao Paulo 04026-000, Brazil

Sao Paulo 04039-000, Brazil

São Paulo 04266-010, Brazil

Plovdiv 4002, Bulgaria

Plovdiv 4003, Bulgaria

Sofia 1612, Bulgaria

Sofia 1606, Bulgaria

Sofia 1233, Bulgaria

St. John's A1C 5B8, Canada

Bruntal 792 01, Czech Republic

Hlucin 748 01, Czech Republic

Olomouc 775 20, Czech Republic

Prague 12850, Czech Republic

Uherske Hradiste 686 01, Czech Republic

Zlin 760 01, Czech Republic

Esbjerg 6700, Denmark

Hellerup 2900, Denmark

Vejle 7100, Denmark

Besancon 25030, France

Bordeaux 33076, France

Boulogne-billancourt 92104, France

Creteil 94010, France

Grenoble 38042, France

Le Kremlin Bicetre 94275, France

Lyon Cedex 3 69437, France

Montpellier 34295, France

Orléans Cedex 2 45067, France

Paris 75571, France

Paris 75679, France

Rouen Cedex 76031, France

Strasbourg 67098, France

Vandoeuvre-les-nancy 54511, France

Berlin 10117, Germany

Berlin 14059, Germany

Erlangen 91054, Germany

Frankfurt 60590, Germany

Gommern 39245, Germany

Hamburg 22081, Germany

Hannover 30625, Germany

Heidelberg 69120, Germany

Herne 44652, Germany

Köln 50924, Germany

München 80336, Germany

Regensburg 93053, Germany

Rostock 18059, Germany

Tuebingen 72076, Germany

Würzburg 97080, Germany

Bangalore 560034, India

Bangalore 560076, India

Jaipur 302 015, India

New Delhi 110029, India

Secunderabad 500003, India

Ferrara 44100, Italy

Firenze 50141, Italy

Monserrato 09042, Italy

Padova 35128, Italy

Pisa 56126, Italy

Prato 59100, Italy

Reggio Emilia 42100, Italy

Roma 00161, Italy

Siena 53100, Italy

Kaunas 50009, Lithuania

Klaipeda 92288, Lithuania

Amsterdam 1105 AZ, Netherlands

Amsterdam 1081 HV, Netherlands

Amsterdam 1056 AB, Netherlands

Bydgoszcz 85-168, Poland

Krakow 31-121, Poland

Lublin 20-954, Poland

Poznan 60-218, Poland

Torun 87-100, Poland

Warszawa 00-909, Poland

Wroclaw 51-124, Poland

Kosice 040 66, Slovakia

Piestany 921 01, Slovakia

Cape Town 7500, South Africa

Cape Town 8001, South Africa

Durban 4001, South Africa

Pinelands 7405, South Africa

Pretoria 0002, South Africa

Stellenbosch 7600, South Africa

Alcorcon 28922, Spain

Barcelona 08036, Spain

Córdoba 14004, Spain

La Coruna 15006, Spain

Lugo 27004, Spain

Madrid 28009, Spain

Madrid 28046, Spain

Madrid 28222, Spain

Oviedo 33006, Spain

Oviedo 33012, Spain

Sabadell 08208, Spain

Basingstoke RG24 9NA, United Kingdom

Bath BA1 1RL, United Kingdom

Greenock PA16 0XN, United Kingdom

Leeds LS7 4SA, United Kingdom

London EC1M 6BQ, United Kingdom

Salford M6 8HD, United Kingdom

Stoke-on-trent ST6 7AG, United Kingdom

Wigan WN6 9EW, United Kingdom

Calgary, Alberta T2N 4N1, Canada

Huntington Beach, California 92646, United States

Aventura, Florida 33180, United States

Miami, Florida 33169, United States

Orlando, Florida 32804, United States

Tampa, Florida 33609, United States

Atlanta, Georgia 30342, United States

Decatur, Georgia 30033, United States

Marietta, Georgia 30060, United States

Idaho Falls, Idaho 83404, United States

Wichita, Kansas 67207, United States

Hagerstown, Maryland 21740, United States

St. Claire Shores, Michigan 48081, United States

Freehold, New Jersey 07728, United States

Asheville, North Carolina 28803, United States

Charlotte, North Carolina 28210, United States

Greensboro, North Carolina 27408, United States

Hamilton, Ontario L8N 1Y2, Canada

Kitchener, Ontario N2M 5N6, Canada

Mississauga, Ontario L5M 2V8, Canada

St. Catharines, Ontario L2N 7E4, Canada

Toronto, Ontario M5T 2S8, Canada

Toronto, Ontario M9W 6V1, Canada

Duncansville, Pennsylvania 16635, United States

Montreal, Quebec H1T 2M4, Canada

Quebec City, Quebec G1V 3M7, Canada

Trois-rivières, Quebec G8Z 1Y2, Canada

Austin, Texas 78731, United States

Houston, Texas 77004, United States

Additional Information

Starting date: October 2010
Last updated: December 11, 2012

Page last updated: August 23, 2015

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