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Spondylitis, AnkylosingPhase 3NCT01209689

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

A Phase 3 study testing Tocilizumab in people with Spondylitis, Ankylosing, run by Hoffmann-La Roche at 140 sites in 19 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spondylitis, Ankylosing
What is being tested?
Tocilizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
113 participants
Where
140 sitesin 19 countries
Study dates
Oct 2010to Dec 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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  • Traditional disease-modifying anti-rheumatic drugs (DMARDs) must be withdrawn for at least 4 weeks prior to baseline (methotrexate, sulfasalazine, and hydroxychloroquine or chloroquine may be allowed if at stable dose for at least 4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

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

140 sites in 19 countries.

140 sites in 19 countries

United States19 sites

  • Study site

    Asheville, North Carolina, 28803

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Austin, Texas, 78731

  • Study site

    Aventura, Florida, 33180

  • Study site

    Charlotte, North Carolina, 28210

  • Study site

    Decatur, Georgia, 30033

  • Study site

    Duncansville, Pennsylvania, 16635

  • Study site

    Freehold, New Jersey, 07728

  • Study site

    Greensboro, North Carolina, 27408

  • Study site

    Hagerstown, Maryland, 21740

  • Study site

    Houston, Texas, 77004

  • Study site

    Huntington Beach, California, 92646

  • Study site

    Idaho Falls, Idaho, 83404

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Miami, Florida, 33169

  • Study site

    Orlando, Florida, 32804

  • Study site

    Saint Claire Shores, Michigan, 48081

  • Study site

    Tampa, Florida, 33609

  • Study site

    Wichita, Kansas, 67207

Other trials in United States

Germany15 sites

  • Study site

    Berlin, 10117

  • Study site

    Berlin, 14059

  • Study site

    Cologne, 50924

  • Study site

    Erlangen, 91054

  • Study site

    Frankfurt, 60590

  • Study site

    Gommern, 39245

  • Study site

    Hamburg, 22081

  • Study site

    Hanover, 30625

  • Study site

    Heidelberg, 69120

  • Study site

    Herne, 44652

  • Study site

    München, 80336

  • Study site

    Regensburg, 93053

  • Study site

    Rostock, 18059

  • Study site

    Tübingen, 72076

  • Study site

    Würzburg, 97080

Other trials in Germany

France14 sites

  • Study site

    Besançon, 25030

  • Study site

    Bordeaux, 33076

  • Study site

    Boulogne-Billancourt, 92104

  • Study site

    Créteil, 94010

  • Study site

    Grenoble, 38042

  • Study site

    Le Kremlin-Bicêtre, 94275

  • Study site

    Lyon, 69437

  • Study site

    Montpellier, 34295

  • Study site

    Orléans, 45067

  • Study site

    Paris, 75571

  • Study site

    Paris, 75679

  • Study site

    Rouen, 76031

  • Study site

    Strasbourg, 67098

  • Study site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Canada11 sites

  • Study site

    Calgary, Alberta, T2N 4N1

  • Study site

    Hamilton, Ontario, L8N 1Y2

  • Study site

    Kitchener, Ontario, N2M 5N6

  • Study site

    Mississauga, Ontario, L5M 2V8

  • Study site

    Montreal, Quebec, H1T 2M4

  • Study site

    Québec, Quebec, G1V 3M7

  • Study site

    St. Catharines, Ontario, L2N 7E4

  • Study site

    St. John's, A1C 5B8

  • Study site

    Toronto, Ontario, M5T 2S8

  • Study site

    Toronto, Ontario, M9W 6V1

  • Study site

    Trois-Rivières, Quebec, G8Z 1Y2

Other trials in Canada

Spain11 sites

  • Study site

    A Coruña, 15006

  • Study site

    Alcorcón, 28922

  • Study site

    Barcelona, 08036

  • Study site

    Córdoba, 14004

  • Study site

    Lugo, 27004

  • Study site

    Madrid, 28009

  • Study site

    Madrid, 28046

  • Study site

    Madrid, 28222

  • Study site

    Oviedo, 33006

  • Study site

    Oviedo, 33012

  • Study site

    Sabadell, 08208

Other trials in Spain

Italy9 sites

  • Study site

    Ferrara, 44100

  • Study site

    Florence, 50141

  • Study site

    Monserrato, 09042

  • Study site

    Padova, 35128

  • Study site

    Pisa, 56126

  • Study site

    Prato, 59100

  • Study site

    Reggio Emilia, 42100

  • Study site

    Roma, 00161

  • Study site

    Siena, 53100

Other trials in Italy

United Kingdom8 sites

  • Study site

    Basingstoke, RG24 9NA

  • Study site

    Bath, BA1 1RL

  • Study site

    Greenock, PA16 0XN

  • Study site

    Leeds, LS7 4SA

  • Study site

    London, EC1M 6BQ

  • Study site

    Salford, M6 8HD

  • Study site

    Stoke-on-Trent, ST6 7AG

  • Study site

    Wigan, WN6 9EW

Other trials in United Kingdom

Poland7 sites

  • Study site

    Bydgoszcz, 85-168

  • Study site

    Krakow, 31-121

  • Study site

    Lublin, 20-954

  • Study site

    Poznan, 60-218

  • Study site

    Torun, 87-100

  • Study site

    Warsaw, 00-909

  • Study site

    Wroclaw, 51-124

Other trials in Poland

Czechia6 sites

  • Study site

    Bruntál, 792 01

  • Study site

    Hlučín, 748 01

  • Study site

    Olomouc, 775 20

  • Study site

    Prague, 12850

  • Study site

    Uherské Hradiště, 686 01

  • Study site

    Zlín, 760 01

Other trials in Czechia

South Africa6 sites

  • Study site

    Cape Town, 7500

  • Study site

    Cape Town, 8001

  • Study site

    Durban, 4001

  • Study site

    Pinelands, 7405

  • Study site

    Pretoria, 0002

  • Study site

    Stellenbosch, 7600

Other trials in South Africa

Belgium5 sites

  • Study site

    Brussels, 1200

  • Study site

    Ghent, 9000

  • Study site

    Kortrijk, 8500

  • Study site

    Liège, 4000

  • Study site

    Yvoir, 5530

Other trials in Belgium

Brazil5 sites

  • Study site

    Cuiabá, 78025-000

  • Study site

    Goiânia, 74110-120

  • Study site

    São Paulo, 04026-000

  • Study site

    São Paulo, 04039-000

  • Study site

    São Paulo, 04266-010

Other trials in Brazil

Bulgaria5 sites

  • Study site

    Plovdiv, 4002

  • Study site

    Plovdiv, 4003

  • Study site

    Sofia, 1233

  • Study site

    Sofia, 1606

  • Study site

    Sofia, 1612

Other trials in Bulgaria

India5 sites

  • Study site

    Bangalore, 560034

  • Study site

    Bangalore, 560076

  • Study site

    Jaipur, 302 015

  • Study site

    New Delhi, 110029

  • Study site

    Secunderabad, 500003

Other trials in India

Australia4 sites

  • Study site

    Heidelberg, 3084

  • Study site

    Hobart, 7000

  • Study site

    Sydney, 2050

  • Study site

    Woodville, 5011

Other trials in Australia

Denmark3 sites

  • Study site

    Esbjerg, 6700

  • Study site

    Hellerup, 2900

  • Study site

    Vejle, 7100

Other trials in Denmark

Netherlands3 sites

  • Study site

    Amsterdam, 1056 AB

  • Study site

    Amsterdam, 1081 HV

  • Study site

    Amsterdam, 1105 AZ

Other trials in Netherlands

Lithuania2 sites

  • Study site

    Kaunas, 50009

  • Study site

    Klaipėda, 92288

Other trials in Lithuania

Slovakia2 sites

  • Study site

    Košice, 040 66

  • Study site

    Piešťany, 921 01

Other trials in Slovakia

About this study

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

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.

Being tested
Tocilizumab, Placebo
Medical subject headings
Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TocilizumabDrug

    Also called RoActemra, Actemra

  • PlaceboDrug

Study groups in NCT01209689
Study groupRoleWhat they receive
Tocilizumab 4 mg/kgExperimentalPatients received tocilizumab 4 mg/kg intravenously every 4 weeks for 24 weeks.
Receives: Drug: Tocilizumab
Tocilizumab 8 mg/kgExperimentalPatients received tocilizumab 8 mg/kg intravenously every 4 weeks for 24 weeks.
Receives: Drug: Tocilizumab
PlaceboPlacebo comparatorPatients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionDec 2011
  4. Study completionDec 2011

Why it stopped: Clinical development program terminated due to failure to achieve efficacy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01209689
Sponsor's protocol ID
WA22908
Other IDs
2009-017488-40, 2009
Status last verified
Dec 2012
First submitted
24 Sep 2010
Last updated
17 Jan 2013

Publications

  • Sieper J, Porter-Brown B, Thompson L, Harari O, Dougados M. Assessment of short-term symptomatic efficacy of tocilizumab in ankylosing spondylitis: results of randomised, placebo-controlled trials. Ann Rheum Dis. 2014 Jan;73(1):95-100. doi: 10.1136/annrheumdis-2013-203559. Epub 2013 Jun 13.

    PubMed 23765873

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tocilizumab in people with Spondylitis, Ankylosing, run by Hoffmann-La Roche at 140 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in United States, Germany, France, Canada, Spain and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of ASsessment in Ankylosing Spondylitis 20 (ASAS20) Responders at Week 12 (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01209689, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2013.

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