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Rheumatoid ArthritisPhase 3NCT00106548

A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

A Phase 3 study testing tocilizumab [RoActemra/Actemra] and Methotrexate in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 74 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with methotrexate (MTX). in patients with moderate to severe active rheumatoid arthritis (RA) who currently have an inadequate response to MTX. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
tocilizumab [RoActemra/Actemra] and Methotrexate
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
623 participants
Where
74 sitesin 17 countries
Study dates
Start not givento Oct 2007
Phase
Phase 3
Are there results?
None posted in the registry

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 at least 18 years of age with moderate to severe active RA for at least 6 months;
  • inadequate response to a stable dose of MTX;
  • patients of reproductive potential must be using reliable methods of contraception.

Who cannot join

  • major surgery (including joint surgery) within 8 weeks before entering study, or planned surgery within 6 months after entering study;
  • prior treatment failure with an anti-tumor necrosis factor agent;
  • women who are pregnant or breast-feeding.

Trial locations and contacts

74 sites in 17 countries.

74 sites in 17 countries

Canada12 sites

  • Study site

    Burlington, Ontario, L7M 4Y1

  • Study site

    Calgary, Alberta, T2N 4N1

  • Study site

    Montreal, Quebec, H1T 4B3

  • Study site

    Montreal, Quebec, H2L 1S6

  • Study site

    Newmarket, Ontario, L3Y 3R7

  • Study site

    Ottawa, Ontario, K1H 1A2

  • Study site

    Sainte-Foy, Quebec, G1W 4R4

  • Study site

    St. John's, Newfoundland and Labrador, A1B 3E1

  • Study site

    Toronto, Ontario, M4N 3M5

  • Study site

    Vancouver, British Columbia, V5Z 1L7

  • Study site

    Victoria, British Columbia, V8V 3P9

  • Study site

    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

Germany8 sites

  • Study site

    Bad Bramstedt, 24576

  • Study site

    Bad Nauheim, 61231

  • Study site

    Baden-Baden, 76530

  • Study site

    Berlin, 14059

  • Study site

    Cologne, 50924

  • Study site

    Erlangen, 91056

  • Study site

    Heidelberg, 69120

  • Study site

    Tübingen, 72076

Other trials in Germany

France7 sites

  • Study site

    Besançon, 25030

  • Study site

    Créteil, 94010

  • Study site

    Le Mans, 72000

  • Study site

    Montpellier, 34295

  • Study site

    Paris, 75010

  • Study site

    Paris, 75012

  • Study site

    Paris, 75014

Other trials in France

Israel6 sites

  • Study site

    Beersheba, 84101

  • Study site

    Haifa, 31048

  • Study site

    Haifa, 31096

  • Study site

    Jerusalem, 91120

  • Study site

    Petah Tikva, 49100

  • Study site

    Tel Aviv, 64239

Other trials in Israel

Mexico6 sites

  • Study site

    Chihuahua City, 31000

  • Study site

    Guadalajara, 44620

  • Study site

    Guadalajara, 44690

  • Study site

    Mexico City, 07760

  • Study site

    Mexico City, 14080

  • Study site

    San Luis Potosí City, 78240

Other trials in Mexico

Italy5 sites

  • Study site

    Ferrara, 44100

  • Study site

    Gazzi, 98125

  • Study site

    Palermo, 90127

  • Study site

    Siena, 53100

  • Study site

    Udine, 33100

Other trials in Italy

Australia4 sites

  • Study site

    Adelaide, 5041

  • Study site

    Douglas, 4184

  • Study site

    Maroochydore, 4558

  • Study site

    Shenton Park, 6008

Other trials in Australia

Austria4 sites

  • Study site

    Vienna, 1090

  • Study site

    Vienna, 1100

  • Study site

    Vienna, 1130

  • Study site

    Vienna, 1160

Other trials in Austria

Argentina3 sites

  • Study site

    Buenos Aires, 1405

  • Study site

    Buenos Aires, C1015ABO

  • Study site

    Buenos Aires, C1428CQG

Other trials in Argentina

Bulgaria3 sites

  • Study site

    Sofia, 1606

  • Study site

    Sofia, 1784

  • Study site

    Varna, 9010

Other trials in Bulgaria

Hungary3 sites

  • Study site

    Budapest, 1023

  • Study site

    Debrecen, 4004

  • Study site

    Pécs, 7632

Other trials in Hungary

Switzerland3 sites

  • Study site

    Bern, 3010

  • Study site

    Lausanne, 1011

  • Study site

    Sankt Gallen, 9007

Other trials in Switzerland

Thailand3 sites

  • Study site

    Bangkok, 10400

  • Study site

    Bangkok, 10700

  • Study site

    Chiang Mai, 50200

Other trials in Thailand

Brazil2 sites

  • Study site

    Porto Alegre, 91350-200

  • Study site

    São Paulo, 05651-901

Other trials in Brazil

China2 sites

  • Study site

    Hong Kong, 852

  • Study site

    Hong Kong

Other trials in China

Singapore2 sites

  • Study site

    Singapore, 119074

  • Study site

    Singapore, 258499

Other trials in Singapore

Slovakia1 site

  • Study site

    Piešťany, 921 01

Other trials in Slovakia

About this study

Official title: A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis

This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with methotrexate (MTX). in patients with moderate to severe active rheumatoid arthritis (RA) who currently have an inadequate response to MTX. Patients wil be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/mg iv, or placebo iv, every 4 weeks; all patients will also receive methotrexate 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Being tested
tocilizumab [RoActemra/Actemra], Placebo, Methotrexate
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • tocilizumab [RoActemra/Actemra]Drug

    4mg/kg iv / month

  • tocilizumab [RoActemra/Actemra]Drug

    8mg/kg iv / month

  • PlaceboDrug

    iv / month

  • MethotrexateDrug

    10-25mg/week

Study groups in NCT00106548
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: tocilizumab [RoActemra/Actemra]; Drug: Methotrexate
2ExperimentalNot described
Receives: Drug: tocilizumab [RoActemra/Actemra]; Drug: Methotrexate
3Placebo comparatorNot described
Receives: Drug: Placebo; Drug: Methotrexate

What is being measured

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

  1. Percentage of patients with ACR 20 response

    Measured: Week 24

Secondary outcomes (2)

  1. Percentage of patients ACR 50/70 responses; change from baseline in ACR core set components.

    Measured: Week 24

  2. AEs, laboratory parameters, vital signs

    Measured: Throughout study

Timeline

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

  1. First posted28 Mar 2005 (estimated)
  2. Study completionOct 2007

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
623 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00106548
Sponsor's protocol ID
WA17822
Status last verified
Jun 2010
First submitted
25 Mar 2005
Last updated
11 Jun 2010
Results posted
No

Publications

  • Keystone EC, Anisfeld A, Ogale S, Devenport JN, Curtis JR. Continued benefit of tocilizumab plus disease-modifying antirheumatic drug therapy in patients with rheumatoid arthritis and inadequate clinical responses by week 8 of treatment. J Rheumatol. 2014 Feb;41(2):216-26. doi: 10.3899/jrheum.130489. Epub 2014 Jan 15.

    PubMed 24429164

  • Wang J, Bansal AT, Martin M, Germer S, Benayed R, Essioux L, Lee JS, Begovich A, Hemmings A, Kenwright A, Taylor KE, Upmanyu R, Cutler P, Harari O, Marchini J, Criswell LA, Platt A. Genome-wide association analysis implicates the involvement of eight loci with response to tocilizumab for the treatment of rheumatoid arthritis. Pharmacogenomics J. 2013 Jun;13(3):235-41. doi: 10.1038/tpj.2012.8. Epub 2012 Apr 10.

    PubMed 22491018

  • Garnero P, Thompson E, Woodworth T, Smolen JS. Rapid and sustained improvement in bone and cartilage turnover markers with the anti-interleukin-6 receptor inhibitor tocilizumab plus methotrexate in rheumatoid arthritis patients with an inadequate response to methotrexate: results from a substudy of the multicenter double-blind, placebo-controlled trial of tocilizumab in inadequate responders to methotrexate alone. Arthritis Rheum. 2010 Jan;62(1):33-43. doi: 10.1002/art.25053.

    PubMed 20039425

  • Smolen JS, Beaulieu A, Rubbert-Roth A, Ramos-Remus C, Rovensky J, Alecock E, Woodworth T, Alten R; OPTION Investigators. Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial. Lancet. 2008 Mar 22;371(9617):987-97. doi: 10.1016/S0140-6736(08)60453-5.

    PubMed 18358926

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tocilizumab [RoActemra/Actemra] and Methotrexate in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 74 sites in 17 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 11 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in Canada, Germany, France, Israel, Mexico and 12 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 patients with ACR 20 response (time frame: Week 24). 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 NCT00106548, which also lists 4 linked publications.

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 11 Jun 2010.

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