Rheumatoid ArthritisPhase 3NCT00106574
A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis
A Phase 3 study testing tocilizumab [RoActemra/Actemra] in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 146 sites in 19 countries.
Trial summary
This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate… 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]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,220 participants
- Where
- 146 sitesin 19 countries
- Study dates
- Apr 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
- patients at least 18 years of age with moderate to severe active RA for at least 6 months;
- inadequate response to current anti-rheumatic therapies, including 1 or more traditional DMARDs;
- stable DMARD therapy for at least 8 weeks before entering study;
- 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;
- patients who have previously failed treatment with an anti-tumor necrosis factor agent;
- women who are pregnant or breast-feeding.
Trial locations and contacts
146 sites in 19 countries.
146 sites in 19 countries
United States76 sites
Study site
Albuquerque, New Mexico, 87131
Study site
Allentown, Pennsylvania, 18103
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Arlington, Virginia, 22204
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Austin, Texas, 78705
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Baton Rouge, Louisiana, 70808
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Beachwood, Ohio, 44122
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Bethlehem, Pennsylvania, 18015
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Boston, Massachusetts, 02111
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Bowling Green, Kentucky, 42102
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Burlington, Vermont, 05401
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Charleston, South Carolina, 29406
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Chicago, Illinois, 60611
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Chicago, Illinois, 60637
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Cincinnati, Ohio, 45219
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Clifton, New Jersey, 07012
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Dayton, Ohio, 45408
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Delray Beach, Florida, 33484
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Duluth, Minnesota, 55805
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Durham, North Carolina, 27704
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Eagan, Minnesota, 55121
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Frederick, Maryland, 21702
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Gallipolis, Ohio, 45631
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Haddon Heights, New Jersey, 08035
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Hixson, Tennessee, 37343
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Houston, Texas, 77074
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Indianapolis, Indiana, 46202
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Johnston, Rhode Island, 02919
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Jupiter, Florida, 33458
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La Crosse, Wisconsin, 54601
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Lansing, Michigan, 48910
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Lincoln, Nebraska, 68516
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Little Rock, Arkansas, 72205
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Los Angeles, California, 90048
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Medford, Oregon, 97504
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Mesa, Arizona, 85208
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Mesquite, Texas, 75150
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Milwaukee, Wisconsin, 53226
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Nashville, Tennessee, 37203
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New Brunswick, New Jersey, 08903
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New York, New York, 10021
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Newark, Delaware, 19713
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Oklahoma City, Oklahoma, 73103
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Oklahoma City, Oklahoma, 73112
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Palm Desert, California, 92260
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Palm Habor, Florida, 34684
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Palm Harbor, Florida, 34684
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Palo Alto, California, 94304
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Paradise Valley, Arizona, 85253
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Peoria, Arizona, 85381
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Philadelphia, Pennsylvania, 19152
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Pittsburgh, Pennsylvania, 15261
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Plainview, New York, 11803
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Raleigh, North Carolina, 27609
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Reno, Nevada, 89502
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Rockledge, Pennsylvania, 19046
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Roslyn, New York, 11576
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Saint Louis Park, Minnesota, 55426
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San Jose, California, 95126
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Scottsdale, Arizona, 85258
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Shreverport, Louisiana, 71103
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Smithtown, New York, 11787
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Spokane, Washington, 99204
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Springfield, Illinois, 62704
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Springfield, Missouri, 65807
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St Louis, Missouri, 63117
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Syracuse, New York, 13210
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Tacoma, Washington, 98405
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Tampa, Florida, 33609
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Tucson, Arizona, 85723
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Tulsa, Oklahoma, 74104
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Upland, California, 91786
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Vancouver, Washington, 98664
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Vernon Hills, Illinois, 60061
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Washington D.C., District of Columbia, 20006
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Willow Grove, Pennsylvania, 19090
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Winston-Salem, North Carolina, 27157
France12 sites
Study site
Boulogne-Billancourt, 92104
Study site
Clermont-Ferrand, 63003
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Grenoble, 38042
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Limoges, 87042
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Marseille, 13285
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Montpellier, 34295
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Nantes, 44035
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Paris, 75181
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Pierre-Bénite, 69495
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Rennes, 35203
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Saint-Etienne, 4200
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Tours, 37044
Germany7 sites
Study site
Aachen, 52064
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Essen, 45239
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Hildesheim, 31134
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München, 80335
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Osnabrück, 49074
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Sendenhorst, 48324
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Stuttgart, 70469
Russia7 sites
Study site
Moscow, 105203
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Moscow, 115522
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Moscow, 117049
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Ryazan, 390026
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Saint Petersburg, 190068
Study site
Saint Petersburg, 191015
Study site
Tula, 300053
Spain6 sites
Study site
Barakaldo, 48903
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Madrid, 28040
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Madrid, 28046
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Málaga, 29010
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Pontevedra, 36001
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Santiago de Compostela, 15706
Canada5 sites
Study site
Hamilton, Ontario, L8N 2B6
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Ottawa, Ontario, K1H 1A2
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Québec, Quebec, G1V 3M7
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Saskatoon, Saskatchewan, S7N 0W8
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Winnipeg, Manitoba, R3A 1M3
China4 sites
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Beijing, 100032
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Beijing, 100044
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Shanghai, 200127
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Shanghai, 200433
Mexico4 sites
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León, 37000
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Mexico City, 07760
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Mexico City, 14050
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Tijuana, 22320
Argentina3 sites
Study site
Buenos Aires, C1015ABO
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Buenos Aires, C1428DQG
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Rosario, S2000PBJ
Brazil3 sites
Study site
Campinas, 13060-803
Study site
Goiânia, 74653-050
Study site
Rio de Janeiro, 20551-030
Czechia3 sites
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Hradec Králové, 500 05
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Prague, 128 50
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Prague, 140 59
South Africa3 sites
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Durban, 4001
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Pretoria, 0002
Study site
Radiokop, 2040
Thailand3 sites
Study site
Bangkok, 10330
Study site
Bangkok, 10400
Study site
Chiang Mai, 50200
About this study
Official title: A Randomized, Double-blind Study of the Effect of Tocilizumab on Reduction in Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to DMARD Therapy
This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Placebo, 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.
PlaceboDrug
iv every 4 weeks
tocilizumab [RoActemra/Actemra]Drug
8mg/kg iv every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: tocilizumab [RoActemra/Actemra] |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with ACR 20 response
Measured: Week 24
Secondary outcomes (3)
Percentage of patients with ACR 50 and ACR 70 responses.
Measured: Week 24
Mean changes in parameters of ACR core set
Measured: Week 24
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.
- First posted28 Mar 2005 (estimated)
- Study startApr 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00106574
- Sponsor's protocol ID
- WA18063
- Status last verified
- Nov 2016
- First submitted
- 25 Mar 2005
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Welsh P, Tuckwell K, McInnes IB, Sattar N. Effect of IL-6 receptor blockade on high-sensitivity troponin T and NT-proBNP in rheumatoid arthritis. Atherosclerosis. 2016 Nov;254:167-171. doi: 10.1016/j.atherosclerosis.2016.10.016. Epub 2016 Oct 8.
PubMed 27744141Keystone 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 24429164Wang 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 22491018Genovese MC, McKay JD, Nasonov EL, Mysler EF, da Silva NA, Alecock E, Woodworth T, Gomez-Reino JJ. Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study. Arthritis Rheum. 2008 Oct;58(10):2968-80. doi: 10.1002/art.23940.
PubMed 18821691
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Study of the Effect of Tocilizumab on Reduction in Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to DMARD Therapy
- ClinicalTrials.gov ID
- NCT00106574
- Acronym / sponsor ID
- WA18063
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,220 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 28 Mar 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: tocilizumab [RoActemra/Actemra] |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients at least 18 years of age with moderate to severe active RA for at least 6 months;
- inadequate response to current anti-rheumatic therapies, including 1 or more traditional DMARDs;
- stable DMARD therapy for at least 8 weeks before entering study;
- patients of reproductive potential must be using reliable methods of contraception.
Key exclusion criteria (3 listed)
- major surgery (including joint surgery) within 8 weeks before entering study, or planned surgery within 6 months after entering study;
- patients who have previously failed treatment with an anti-tumor necrosis factor agent;
- women who are pregnant or breast-feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placeboiv every 4 weeks | Drug | 2 |
| tocilizumab [RoActemra/Actemra]8mg/kg iv every 4 weeks | Drug | 1 |
Primary outcome
Percentage of patients with ACR 20 response
Time frame: Week 24
3 secondary outcomes
Percentage of patients with ACR 50 and ACR 70 responses.
Time frame: Week 24
Mean changes in parameters of ACR core set
Time frame: Week 24
AEs, laboratory parameters, vital signs.
Time frame: Throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Derived from this study: PubMed 27744141Welsh P, Tuckwell K, McInnes IB, Sattar N. Effect of IL-6 receptor blockade on high-sensitivity troponin T and NT-proBNP in rheumatoid arthritis. Atherosclerosis. 2016 Nov;254:167-171. doi: 10.1016/j.atherosclerosis.2016.10.016. Epub 2016 Oct 8.
- Derived from this study: PubMed 24429164Keystone 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.
- Derived from this study: PubMed 22491018Wang 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.
- Derived from this study: PubMed 18821691Genovese MC, McKay JD, Nasonov EL, Mysler EF, da Silva NA, Alecock E, Woodworth T, Gomez-Reino JJ. Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study. Arthritis Rheum. 2008 Oct;58(10):2968-80. doi: 10.1002/art.23940.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
146 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tocilizumab [RoActemra/Actemra] in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 146 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 4 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 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 146 sites in United States, France, Germany, Russia, 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?
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 NCT00106574, 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 2 Nov 2016.