A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic and/or Biologic DMARDS
NCT ID: NCT01149057
Last Updated: 2016-11-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
145 participants
INTERVENTIONAL
2010-10-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
tocilizumab [RoActemra/Actemra]
8 mg/kg intravenously, every 4 weeks for 96 weeks
Interventions
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tocilizumab [RoActemra/Actemra]
8 mg/kg intravenously, every 4 weeks for 96 weeks
Eligibility Criteria
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Inclusion Criteria
* Active moderate to severe rheumatoid arthritis
* Inadequate response to \>/=3 DMARDs (non-biologic and/or biologic)
* Current treatment at stable dose for \>/=8 weeks
* Etanercept discontinued \>/=2 weeks, Anakinra \>/=1 week, Infliximab, Adalimumab, Abatacept, Golimumab, Certolizumab \>/=4 weeks, prior to baseline visit. Patients have discontinued MabThera/Rituxan or Ocrelizumab \>/=16 weeks, and must have proven B-cell repletion
Exclusion Criteria
* Rheumatic autoimmune disease other than RA
* Functional class IV (American College of Rheumatology Classification)
* Prior history or current inflammatory joint disease other than RA
* Oral corticosteroids at a dose of \>10 mg/day prednisone equivalent
* Positive hepatitis B surface antigen (HBsAg) and / or total hepatitis B core antibodies (HBcAb) or hepatitis C virus (HCV) antibody
* Current or history of recurrent bacterial, viral, fungal or mycobaterial infection
* History of or currently active primary or secondary immunodeficiency
18 Years
ALL
No
Sponsors
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Clalit Health Services
OTHER
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Afula, , Israel
Ashkelon, , Israel
Beer Yaakov, , Israel
Beersheba, , Israel
Hadera, , Israel
Haifa, , Israel
Haifa, , Israel
Haifa, , Israel
Holon, , Israel
Jerusalem, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Countries
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Other Identifiers
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ML22873
Identifier Type: -
Identifier Source: org_study_id