A Study to Assess Efficacy With Respect to Clinical Improvement in Disease Activity and Safety of Tocilizumab in Patients Wtih Active Rheumatoid Arthritis.
"Effectiveness After Four and Twentyfour Weeks and Safety of Tocilizumab in Patients With Active RA"
2 other identifiers
interventional
286
1 country
81
Brief Summary
This single arm study will assess the effectiveness of tocilizumab in combination with traditional DMARDs with regard to the clinical improvement in disease activity (achievement of LDAS) after 24 weeks' treatment in patients with active rheumatoid arthritis (RA) who have had an inadequate response to current traditional DMARD and/or anti-TNF therapy. Patients will receive tocilizumab 8mg/kg iv every 4 weeks, in addition to ongoing DMARDs at the stable pre-entry dose prescribed by the physician, for a total of 6 infusions during the regular treatment period and a further 6 infusions during an optional extension phase. The anticipated time on study treatment is 6 to 12 months, and the target sample size is \<500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 rheumatoid-arthritis
Started Aug 2008
Shorter than P25 for phase_3 rheumatoid-arthritis
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 17, 2008
CompletedFirst Posted
Study publicly available on registry
September 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
June 10, 2014
CompletedFebruary 8, 2016
January 1, 2016
1.3 years
September 17, 2008
April 7, 2014
January 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Low Disease Activity Score at Week 24
Low Disease Activity Score (LDAS) is defined as Disease Activity score less than or equal to (≤ ) 3.2. Disease activity score 28 (DAS28) was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and global health assessment (participant rated global assessment of disease activity using 100-mm Visual analog scale \[VAS\]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.
Week 24
Secondary Outcomes (20)
Absolute Changes in DAS28 From Baseline
Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category
Week 24
Percentage of Participants With a DAS28 Response at Weeks 4 and 24
Weeks 4 and 24
Percentage of Participants With an American College of Rheumatology 20%, 50%, or 70% (ACR20/ACR50/ACR70) Response
Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Change From Baseline in Swollen and Tender Joint Counts at Week 24
Week 24
- +15 more secondary outcomes
Study Arms (1)
Tocilizumab
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- adult patients, \>=18 years of age;
- rheumatoid arthritis of \>=6 months duration diagnosed according to the revised 1987 ACR criteria;
- DAS28 of \>3.2;
- At screening either ESR \>=28 mm/h or CRP \>=1 mg/dL;
- Having received permitted DMARDs, 1 or more; current DMARD therapy must have been at a stable dose for at least 8 weeks prior to baseline.
You may not qualify if:
- major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following screening;
- functional class IV as identified by the ACR classification of functional status in RA;
- rheumatoid autoimmune disease other than RA;
- prior history of or current inflammatory joint disease other than RA.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (81)
Unknown Facility
Aachen, 52064, Germany
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Bad Abbach, 93077, Germany
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Bad Aibling, 83043, Germany
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Bad Bramstedt, 24576, Germany
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Bad Nauheim, 61231, Germany
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Baden-Baden, 76530, Germany
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Bayreuth, 95445, Germany
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Berlin, 10117, Germany
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Berlin, 12161, Germany
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Berlin, 12435, Germany
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Berlin, 13055, Germany
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Berlin, 13125, Germany
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Berlin, 14109, Germany
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Berlin, 14163, Germany
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Bremen, 28199, Germany
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Cologne, 50679, Germany
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Cologne, 50924, Germany
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Cuxhaven, 27476, Germany
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Damp, 24351, Germany
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Donaueschingen, 78166, Germany
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Dresden, 01067, Germany
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Dresden, 01109, Germany
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Dresden, 01307, Germany
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Düsseldorf, 40217, Germany
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Düsseldorf, 40225, Germany
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Erfurt, 99096, Germany
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Erlangen, 91054, Germany
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Erlangen, 91056, Germany
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Essen, 45239, Germany
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Frankfurt, 60596, Germany
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Frankfurt am Main, 60590, Germany
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Fulda, 36039, Germany
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Gommern, 39245, Germany
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Goslar, 38642, Germany
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Göttingen, 37075, Germany
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Grafschaft, 53501, Germany
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Hagen, 58135, Germany
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Halle, 06108, Germany
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Halle, 06120, Germany
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Hamburg, 22081, Germany
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Hamburg, 22147, Germany
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Hamburg, 22609, Germany
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Hamburg, 22767, Germany
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Hanover, 30625, Germany
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Heidelberg, 69120, Germany
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Herne, 44652, Germany
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Hildesheim, 31134, Germany
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Hofheim, 65719, Germany
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Homburg/saar, 66424, Germany
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Hoyerswerda, 02977, Germany
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Leipzig, 04103, Germany
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Ludwigsfelde, 14974, Germany
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Ludwigshafen, 67063, Germany
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Lüneburg, 21335, Germany
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Mainz, 55122, Germany
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Mainz, 55131, Germany
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Marburg, 35037, Germany
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München, 80335, Germany
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München, 80336, Germany
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München, 81541, Germany
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München, 81925, Germany
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Münster, 48149, Germany
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Naunhof, 04683, Germany
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Neuss, 41460, Germany
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Nuremberg, 90402, Germany
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Oberammergau, 82487, Germany
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Osnabrück, 49074, Germany
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Pirna, 01796, Germany
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Plochingen, 73207, Germany
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Potsdam, 14469, Germany
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Ratingen, 40882, Germany
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Rostock, 18059, Germany
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Sendenhorst, 48324, Germany
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Stuttgart, 70178, Germany
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Stuttgart, 70372, Germany
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Treuenbrietzen, 14929, Germany
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Tübingen, 72076, Germany
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Ulm, 89081, Germany
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Wiesbaden, 65189, Germany
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Würselen, 52146, Germany
Unknown Facility
Zeven, 27404, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann- LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2008
First Posted
September 18, 2008
Study Start
August 1, 2008
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
February 8, 2016
Results First Posted
June 10, 2014
Record last verified: 2016-01