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Rheumatoid ArthritisPhase 3NCT00109408

A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis

A Phase 3 study testing Methotrexate and tocilizumab [RoActemra/Actemra] in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 147 sites in 18 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 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. 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?
Methotrexate and tocilizumab [RoActemra/Actemra]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
673 participants
Where
147 sitesin 18 countries
Study dates
Jul 2005to Dec 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 active RA for at least 3 months;
  • 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 major surgery within 6 months after entering study;
  • treatment with methotrexate (MTX) within 6 months of entering study;
  • patients who have stopped previous MTX treatment due to toxicity or lack of response;
  • women who are pregnant or breast-feeding.

Trial locations and contacts

147 sites in 18 countries.

147 sites in 18 countries

United States70 sites

  • Study site

    Albany, New York, 12206

  • Study site

    Amarillo, Texas, 79124

  • Study site

    Austin, Texas, 78705

  • Study site

    Baton Rouge, Louisiana, 70808

  • Study site

    Bowling Green, Kentucky, 42102

  • Study site

    Canton, Ohio, 44718

  • Study site

    Cedar Rapids, Iowa, 52401

  • Study site

    Charleston, South Carolina, 29406

  • Study site

    Chesapeake, Virginia, 23320

  • Study site

    Columbia, South Carolina, 29204

  • Study site

    Des Moines, Iowa, 50322

  • Study site

    Dover, New Hampshire, 03820

  • Study site

    Duncansville, Pennsylvania, 16635

  • Study site

    Eagan, Minnesota, 55121

  • Study site

    Fayetteville, North Carolina, 28304

  • Study site

    Flowood, Mississippi, 39232

  • Study site

    Grand Rapids, Michigan, 49546

  • Study site

    Greenbelt, Maryland, 20770

  • Study site

    Greenville, South Carolina, 29601

  • Study site

    Haddon Heights, New Jersey, 08035

  • Study site

    Hickory Grove, South Carolina, 28602

  • Study site

    Hixson, Tennessee, 37343

  • Study site

    Huntington Beach, California, 92646

  • Study site

    Idaho Falls, Idaho, 83404

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Jupiter, Florida, 33458

  • Study site

    Kalamazoo, Michigan, 49048

  • Study site

    Lansing, Michigan, 48910

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Long Beach, California, 90806

  • Study site

    Los Angeles, California, 90045

  • Study site

    Mayfield, Ohio, 44143

  • Study site

    Meridian, Idaho, 83642

  • Study site

    Mesa, Arizona, 85208

  • Study site

    Mesquite, Texas, 75150

  • Study site

    Montgomery, Alabama, 36111

  • Study site

    Morton Grove, Illinois, 60053

  • Study site

    Mountlake Terrace, Washington, 98043

  • Study site

    Nashua, New Hampshire, 03060

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New Brunswick, New Jersey, 08903

  • Study site

    Oklahoma City, Oklahoma, 73103

  • Study site

    Oklahoma City, Oklahoma, 73109

  • Study site

    Olympia, Washington, 98502

  • Study site

    Palm Habor, Florida, 34684

  • Study site

    Palm Harbor, Florida, 34684

  • Study site

    Palm Springs, California, 92262

  • Study site

    Paradise Valley, Arizona, 85253

  • Study site

    Philadelphia, Pennsylvania, 19152

  • Study site

    Phoenix, Arizona, 85013

  • Study site

    Pittsfield, Massachusetts, 01201

  • Study site

    Port Orange, Florida, 32127

  • Study site

    Sacramento, California, 95825

  • Study site

    Saint Cloud, Minnesota, 56303

  • Study site

    San Leandro, California, 94578

  • Study site

    Santa Maria, California, 93454

  • Study site

    Slidell, Louisiana, 70458

  • Study site

    Spokane, Washington, 99204

  • Study site

    Springfield, Illinois, 62704

  • Study site

    St Louis, Missouri, 63117

  • Study site

    St Louis, Missouri, 63131

  • Study site

    Syracuse, New York, 13210

  • Study site

    Tampa, Florida, 33609

  • Study site

    Tampa, Florida, 33614

  • Study site

    Tulsa, Oklahoma, 74104

  • Study site

    Tulsa, Oklahoma, 74135

  • Study site

    Tupelo, Mississippi, 38802

  • Study site

    Willow Grove, Pennsylvania, 19090

  • Study site

    Wyomissing, Pennsylvania, 19610

  • Study site

    Yakima, Washington, 98902

Other trials in United States

Canada9 sites

  • Study site

    Burlington, Ontario, L7M 4Y1

  • Study site

    Hamilton, Ontario, L8N 2B6

  • Study site

    Kitchener, Ontario, N2M 5N6

  • Study site

    Mississauga, Ontario, L5M 2V8

  • Study site

    Ottawa, Ontario, K1H 1A2

  • Study site

    St. John's, Newfoundland and Labrador, A1A 5E8

  • Study site

    Victoria, British Columbia, V8V 3P9

  • Study site

    Winnipeg, Manitoba, R3A 1M3

  • Study site

    Winnipeg, Manitoba, R3A 1M4

Other trials in Canada

Spain9 sites

  • Study site

    Alcorcón, 28922

  • Study site

    Barcelona, 08035

  • Study site

    Córdoba, 14004

  • Study site

    Guadalajara, 19002

  • Study site

    Lugo, 27004

  • Study site

    Salamanca, 37007

  • Study site

    San Cristóbal de La Laguna, 38320

  • Study site

    Santiago de Compostela, 15706

  • Study site

    Valencia, 46017

Other trials in Spain

Israel7 sites

  • Study site

    Ashkelon, 78306

  • Study site

    Beersheba, 8410101

  • Study site

    Haifa, 31048

  • Study site

    Haifa, 34354

  • Study site

    Kfar Saba, 44281

  • Study site

    Ramat Gan, 52621

  • Study site

    Rishon LeZiyyon, 70300

Other trials in Israel

Australia6 sites

  • Study site

    Adelaide, 5041

  • Study site

    Hobart, 7000

  • Study site

    Shenton Park, 6008

  • Study site

    Sydney, 2050

  • Study site

    Woodville, 5011

  • Study site

    Woolloongabba, 4102

Other trials in Australia

Mexico6 sites

  • Study site

    Guadalajara, 44340

  • Study site

    Guadalajara, 44620

  • Study site

    Guadalajara, 45235

  • Study site

    Mexico City, 06700

  • Study site

    Mexico City, 07760

  • Study site

    Mexico City, 14050

Other trials in Mexico

Italy5 sites

  • Study site

    Genova, 16132

  • Study site

    Milan, 20157

  • Study site

    Pavia, 27100

  • Study site

    Reggio Emilia, 42100

  • Study site

    Siena, 53100

Other trials in Italy

Lithuania5 sites

  • Study site

    Kaunas, 50009

  • Study site

    Klaipėda, 92288

  • Study site

    Panevezys, 35144

  • Study site

    Šiauliai, 76231

  • Study site

    Vilnius, LT-08661

Other trials in Lithuania

South Africa5 sites

  • Study site

    Cape Town, 4001

  • Study site

    Cape Town, 7500

  • Study site

    Diepkloof, 1862

  • Study site

    Pinelands, 7405

  • Study site

    Radiokop, 2040

Other trials in South Africa

Argentina4 sites

  • Study site

    Buenos Aires, C1015ABO

  • Study site

    Buenos Aires, C1428DQG

  • Study site

    Rosario, S2000PBJ

  • Study site

    San Juan Bautista, B1878DVB

Other trials in Argentina

France4 sites

  • Study site

    Brest, 29609

  • Study site

    Lyon, 69437

  • Study site

    Paris, 75679

  • Study site

    Rouen, 76031

Other trials in France

China3 sites

  • Study site

    Guangzhou, 510630

  • Study site

    Hefei Anhui, 230022

  • Study site

    Jinan, 250012

Other trials in China

Denmark3 sites

  • Study site

    Copenhagen, 2400

  • Study site

    Hillerød, 3400

  • Study site

    Hvidovre, 2650

Other trials in Denmark

Portugal3 sites

  • Study site

    Almada, 2801-951

  • Study site

    Lisbon, 1050-34

  • Study site

    Lisbon, 1349-019

Other trials in Portugal

Norway2 sites

  • Study site

    Levanger, 7600

  • Study site

    Lillehammer, 2609

Other trials in Norway

Peru2 sites

  • Study site

    Lima, 11

  • Study site

    Lima, 13

Other trials in Peru

Serbia2 sites

  • Study site

    Belgrade, 11000

  • Study site

    Niška Banja, 18250

Other trials in Serbia

Slovenia2 sites

  • Study site

    Ljubljana, 1000

  • Study site

    Maribor, 2000

Other trials in Slovenia

About this study

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

This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.

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

What participants receive

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

  • MethotrexateDrug

    7.5-20mg po weekly

  • tocilizumab [RoActemra/Actemra]Drug

    8mg/kg iv every 4 weeks

Study groups in NCT00109408
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: tocilizumab [RoActemra/Actemra]
2Active comparatorNot described
Receives: 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 (4)

  1. Percentage of patients with ACR 20 response

    Measured: Week 8

  2. Percentage of patients with ACR 50 and ACR 70 responses

    Measured: Week 24

  3. Mean change in parameters of ACR core set

    Measured: Week 24

  4. 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 Apr 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionDec 2007
  4. Study completionDec 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
673 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00109408
Sponsor's protocol ID
WA17824
Status last verified
Nov 2016
First submitted
27 Apr 2005
Last updated
2 Nov 2016
Results posted
No

Publications

  • Drobinski PJ, Bay-Jensen AC, Karsdal MA, Sardar S, Siebuhr AS. Connective tissue remodelling is differently modulated by tocilizumab versus methotrexate monotherapy in patients with early rheumatoid arthritis: the AMBITION study. Arthritis Res Ther. 2021 Jan 7;23(1):13. doi: 10.1186/s13075-020-02378-7.

    PubMed 33413588

  • Strand V, Michalska M, Birchwood C, Pei J, Tuckwell K, Finch R, Gabay C, Kavanaugh A, Jones G. Impact of tocilizumab monotherapy on patient-reported outcomes in patients with rheumatoid arthritis from two randomised controlled trials. RMD Open. 2017 Sep 14;3(2):e000496. doi: 10.1136/rmdopen-2017-000496. eCollection 2017.

    PubMed 28955499

  • Jones G, Wallace T, McIntosh MJ, Brockwell L, Gomez-Reino JJ, Sebba A. Five-year Efficacy and Safety of Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Methotrexate- and Biologic-naive or Free of Methotrexate for 6 Months: the AMBITION Study. J Rheumatol. 2017 Feb;44(2):142-146. doi: 10.3899/jrheum.160287. Epub 2016 Dec 1.

    PubMed 27909081

  • 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

  • Jones G, Sebba A, Gu J, Lowenstein MB, Calvo A, Gomez-Reino JJ, Siri DA, Tomsic M, Alecock E, Woodworth T, Genovese MC. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study. Ann Rheum Dis. 2010 Jan;69(1):88-96. doi: 10.1136/ard.2008.105197.

    PubMed 19297346

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Methotrexate and tocilizumab [RoActemra/Actemra] in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 147 sites in 18 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 2 inclusion and 4 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 147 sites in United States, Canada, Spain, Israel, Australia and 13 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. 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 NCT00109408, which also lists 5 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 2 Nov 2016.

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