Rheumatoid ArthritisPhase 3NCT00106522
A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis Currently on Methotrexate Therapy
A Phase 3 study testing Methotrexate and tocilizumab [RoActemra/Actemra] in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 168 sites in 14 countries.
Trial summary
This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior… 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?
- Yes, some participants may receive a placebo
- How many people
- 499 participants
- Where
- 168 sitesin 14 countries
- Study dates
- May 2005to Nov 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 current anti-rheumatic therapies, including MTX;
- inadequate response or intolerance to treatment with 1 or more anti-TNF therapies within 1 year of entering study;
- on stable MTX 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 screening, or planned major surgery within 6 months after entering study;
- women who are pregnant or breast-feeding.
Trial locations and contacts
168 sites in 14 countries.
168 sites in 14 countries
United States97 sites
Study site
Albany, New York, 12206
Study site
Anaheim, California, 92801
Study site
Asheville, North Carolina, 28801
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Atlanta, Georgia, 30342
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Austin, Texas, 78705
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Aventura, Florida, 33180
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Bala-Cynwyd, Pennsylvania, 19004
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Baltimore, Maryland, 21201
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Baltimore, Maryland, 21205
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Billings, Montana, 59107-5100
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Binghamton, New York, 13905
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Birmingham, Alabama, 35294
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Bismarck, North Dakota, 58501
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Boca Raton, Florida, 33486
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Boise, Idaho, 83702
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Bowling Green, Kentucky, 42102
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Canton, Ohio, 44718
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Chapel Hill, North Carolina, 27599-7280
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Charlotte, North Carolina, 28210
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Chicago, Illinois, 60611
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Cincinnati, Ohio, 45219
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Colorado Springs, Colorado, 80910
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Dallas, Texas, 75231-4406
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Dallas, Texas, 75231
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Danville, Pennsylvania, 17822
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Duluth, Minnesota, 55805
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Duncansville, Pennsylvania, 16635
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Elizabethtown, Kentucky, 42701
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Eugene, Oregon, 97401
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Fort Lauderdale, Florida, 33334
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Fullerton, California, 92835
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Glendale, Wisconsin, 53217
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Great Neck, New York, 11020
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Hickory Grove, South Carolina, 28602
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Hot Springs, Arkansas, 71913
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Houston, Texas, 77074
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Huntsville, Alabama, 35801
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Indianapolis, Indiana, 46202-5100
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Jackson, Tennessee, 38305
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Johnson City, New York, 13790
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Lansing, Michigan, 48910
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Las Vegas, Nevada, 89119
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Lexington, Kentucky, 40515
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Little Rock, Arkansas, 72205
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Long Beach, California, 90806
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Long Beach, California, 90808
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Los Angeles, California, 90095
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Louisville, Kentucky, 40202
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Medford, New Jersey, 08055
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Mercerville, New Jersey, 08619
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Meridian, Idaho, 83642
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Missoula, Montana, 59802
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New Orleans, Louisiana, 70121
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New York, New York, 10003
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New York, New York, 10021
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Norfolk, Virginia, 23502
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Ogden, Utah, 84403
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Oklahoma City, Oklahoma, 73103
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Orchard Park, New York, 14127
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Palm Desert, California, 92260
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Palm Habor, Florida, 34684
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Philadelphia, Pennsylvania, 19140
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Philadelphia, Pennsylvania, 19152
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Portland, Maine, 04102
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Richmond, Virginia, 23298
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Rochester, Minnesota, 55905
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Rochester, New York, 14618
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Salem, Virginia, 24153
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San Diego, California, 92101
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San Diego, California, 92108
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Santa Maria, California, 93454
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Sarasota, Florida, 34239
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Scottsdale, Arizona, 85251
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Scottsdale, Arizona, 85258
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Seattle, Washington, 98104
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Seattle, Washington, 98195
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Springfield, Illinois, 62703
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Springfield, Illinois, 62704
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Springfield, Massachusetts, 01107
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St Louis, Missouri, 63110
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St Louis, Missouri, 63128
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St Louis, Missouri, 63131
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St Louis, Missouri, 63141
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Tampa, Florida, 33614
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Tavares, Florida, 32778
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Teaneck, New Jersey, 07666
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Torrance, California, 90505
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Tucson, Arizona, 85724
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Tulsa, Oklahoma, 74104
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Tulsa, Oklahoma, 74135
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Tupelo, Mississippi, 38802
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West Palm Beach, Florida, 33407
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Wheaton, Maryland, 20902
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Willow Grove, Pennsylvania, 80045
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Wilmington, North Carolina, 28401
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Worcester, Massachusetts, 01605
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Zephyrhills, Florida, 33540
United Kingdom19 sites
Study site
Basingstoke, RG24 9NA
Study site
Bath, BA1 1RL
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Birmingham, B29 6JD
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Cannock, WS11 5XY
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Derby, DE22 3NE
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Lancaster, LA1 4RP
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Leeds, LS1 3EX
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Liverpool, L9 7AL
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London, SE1 9RT
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London, SE5 9PJ
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Manchester, M13 9WL
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Manchester, M41 5SL
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Middlesbrough, TS4 3BW
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Newcastle upon Tyne, NE1 4LP
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Norwich, NR4 7UY
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Oxford, OX3 7LD
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Salford, M6 8HD
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Southampton, SO16 6YD
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Stoke-on-Trent, ST6 7AG
Canada10 sites
Study site
Burlington, Ontario, L7M 4Y1
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Calgary, Alberta, T2V 1P9
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Edmonton, Alberta, T5H 3V9
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Kitchener, Ontario, N2M 5N6
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London, Ontario, N6A 4V2
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Mississauga, Ontario, L5M 2V8
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Montreal, Quebec, H2L 1S6
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Newmarket, Ontario, L3Y 3R7
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Toronto, Ontario, M5T 3L9
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Winnipeg, Manitoba, R3A 1M3
France10 sites
Study site
Amiens, 80054
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Bordeaux, 33076
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Le Kremlin-Bicêtre, 94275
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Lille, 59037
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Lyon, 69437
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Nice, 06202
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Paris, 75475
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Paris, 75679
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Strasbourg, 67098
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Toulouse, 31054
Germany8 sites
Study site
Berlin, 10117
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Cologne, 50924
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Dresden, 01067
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Gommern, 39245
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Herne, 44652
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München, 81541
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Wiesbaden, 65191
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Würzburg, 97080
Italy7 sites
Study site
Brescia, 25123
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Milan, 20122
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Milan, 20157
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Padova, 35128
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Pavia, 27100
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Pisa, 56100
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Udine, 33100
Australia4 sites
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Malvern, 3144
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Shenton Park, 6008
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Sydney, 2050
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Woolloongabba, 4102
Sweden4 sites
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Jönköping, 551 85
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Karlstad, 65185
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Malmö, 205 02
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Stockholm, 171 76
Belgium3 sites
Study site
Aalst, 9300
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Hasselt, 3500
Study site
Merksem, 2170
Netherlands2 sites
Study site
Enschede, 7511 JX
Study site
Nijmegen, 6525 GA
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 Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy
This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Methotrexate, 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.
MethotrexateDrug
10-25mg weekly
PlaceboDrug
iv every 4 weeks
tocilizumab [RoActemra/Actemra]Drug
8mg/kg iv every 4 weeks
tocilizumab [RoActemra/Actemra]Drug
4mg/kg iv every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Methotrexate; Drug: tocilizumab [RoActemra/Actemra] |
| 2 | Experimental | Not described Receives: Drug: Methotrexate; Drug: tocilizumab [RoActemra/Actemra] |
| 3 | Placebo comparator | Not described Receives: Drug: Methotrexate; 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
AEs, laboratory parameters, vital signs, ECGs.
Measured: Throughout study
Secondary outcomes (2)
Percentage of patients with ACR 50 and ACR 70 responses
Measured: Week 24
Mean changes in parameters of ACR core set
Measured: Week 24
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 startMay 2005
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- 499 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
- NCT00106522
- Sponsor's protocol ID
- WA18062
- Status last verified
- Nov 2016
- First submitted
- 25 Mar 2005
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Vieira MC, Zwillich SH, Jansen JP, Smiechowski B, Spurden D, Wallenstein GV. Tofacitinib Versus Biologic Treatments in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results From a Network Meta-analysis. Clin Ther. 2016 Dec;38(12):2628-2641.e5. doi: 10.1016/j.clinthera.2016.11.004. Epub 2016 Nov 24.
PubMed 27889300Keystone 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 24429164Strand V, Burmester GR, Ogale S, Devenport J, John A, Emery P. Improvements in health-related quality of life after treatment with tocilizumab in patients with rheumatoid arthritis refractory to tumour necrosis factor inhibitors: results from the 24-week randomized controlled RADIATE study. Rheumatology (Oxford). 2012 Oct;51(10):1860-9. doi: 10.1093/rheumatology/kes131. Epub 2012 Jun 28.
PubMed 22753773Karsdal MA, Schett G, Emery P, Harari O, Byrjalsen I, Kenwright A, Bay-Jensen AC, Platt A. IL-6 receptor inhibition positively modulates bone balance in rheumatoid arthritis patients with an inadequate response to anti-tumor necrosis factor therapy: biochemical marker analysis of bone metabolism in the tocilizumab RADIATE study (NCT00106522). Semin Arthritis Rheum. 2012 Oct;42(2):131-9. doi: 10.1016/j.semarthrit.2012.01.004. Epub 2012 Mar 6.
PubMed 22397953Emery P, Keystone E, Tony HP, Cantagrel A, van Vollenhoven R, Sanchez A, Alecock E, Lee J, Kremer J. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial. Ann Rheum Dis. 2008 Nov;67(11):1516-23. doi: 10.1136/ard.2008.092932. Epub 2008 Jul 14.
PubMed 18625622
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 Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy
- ClinicalTrials.gov ID
- NCT00106522
- Acronym / sponsor ID
- WA18062
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 499 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 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 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. 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
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Methotrexate, Drug: tocilizumab [RoActemra/Actemra] |
| 2 | Experimental | Drug: Methotrexate, Drug: tocilizumab [RoActemra/Actemra] |
| 3 | Placebo comparator | Drug: Methotrexate, Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult 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 MTX;
- inadequate response or intolerance to treatment with 1 or more anti-TNF therapies within 1 year of entering study;
- on stable MTX for at least 8 weeks before entering study;
- patients of reproductive potential must be using reliable methods of contraception.
Key exclusion criteria (2 listed)
- major surgery (including joint surgery) within 8 weeks before screening, or planned major surgery within 6 months after entering study;
- 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 |
|---|---|---|
| Methotrexate10-25mg weekly | Drug | 1, 2, 3 |
| Placeboiv every 4 weeks | Drug | 3 |
| tocilizumab [RoActemra/Actemra]8mg/kg iv every 4 weeks | Drug | 2 |
| tocilizumab [RoActemra/Actemra]4mg/kg iv every 4 weeks | Drug | 1 |
Primary outcome
Percentage of patients with ACR 20 response
Time frame: Week 24
AEs, laboratory parameters, vital signs, ECGs.
Time frame: Throughout study
2 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
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 27889300Vieira MC, Zwillich SH, Jansen JP, Smiechowski B, Spurden D, Wallenstein GV. Tofacitinib Versus Biologic Treatments in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results From a Network Meta-analysis. Clin Ther. 2016 Dec;38(12):2628-2641.e5. doi: 10.1016/j.clinthera.2016.11.004. Epub 2016 Nov 24.
- 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 22753773Strand V, Burmester GR, Ogale S, Devenport J, John A, Emery P. Improvements in health-related quality of life after treatment with tocilizumab in patients with rheumatoid arthritis refractory to tumour necrosis factor inhibitors: results from the 24-week randomized controlled RADIATE study. Rheumatology (Oxford). 2012 Oct;51(10):1860-9. doi: 10.1093/rheumatology/kes131. Epub 2012 Jun 28.
- Derived from this study: PubMed 22397953Karsdal MA, Schett G, Emery P, Harari O, Byrjalsen I, Kenwright A, Bay-Jensen AC, Platt A. IL-6 receptor inhibition positively modulates bone balance in rheumatoid arthritis patients with an inadequate response to anti-tumor necrosis factor therapy: biochemical marker analysis of bone metabolism in the tocilizumab RADIATE study (NCT00106522). Semin Arthritis Rheum. 2012 Oct;42(2):131-9. doi: 10.1016/j.semarthrit.2012.01.004. Epub 2012 Mar 6.
- Derived from this study: PubMed 18625622Emery P, Keystone E, Tony HP, Cantagrel A, van Vollenhoven R, Sanchez A, Alecock E, Lee J, Kremer J. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial. Ann Rheum Dis. 2008 Nov;67(11):1516-23. doi: 10.1136/ard.2008.092932. Epub 2008 Jul 14.
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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
168 sites in 14 countries: see every site and its status.
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 168 sites in 14 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 5 inclusion and 2 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 168 sites in United States, United Kingdom, Canada, France, Germany and 9 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). The study lists 2 primary outcomes in all. 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 NCT00106522, 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.