A Study Assessing the Safety and Efficacy of Subcutaneous RoActemra/Actemra Alone or in Combination With Non-biologic Antirheumatics in Rhuematoid Arthritis Patients in Latin America With Inadequate Response to Non-biologic Antirheumatic Drugs.
NCT ID: NCT02011334
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
285 participants
INTERVENTIONAL
2014-07-31
2016-10-31
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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RoActemra/Actemra
tocilizumab [RoActemra/Actemra]
162 mg will be administered once weekly by subcutaneous injection.
Interventions
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tocilizumab [RoActemra/Actemra]
162 mg will be administered once weekly by subcutaneous injection.
Eligibility Criteria
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Inclusion Criteria
* Patients with a diagnosis of active RA according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria.
* Patients with moderate to severe RA (DAS-ESR 28 \>/= 3.2).
* Receiving non-study treatment on an outpatient basis.
* Oral corticosteroids (\</= 10 mg/day prednisone or equivalent), NSAIDs and non-biologic DMARDs are permitted if on a stable dose regimen for \>/= 4 weeks prior to Baseline.
* Inadequate response to previous non-biologic DMARD therapy.
* Use of effective contraception throughout the study as defined by protocol; female patients of childbearing potential cannot be pregnant.
Exclusion Criteria
* History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower GI disease that might predispose to perforation.
* Current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections.
* Any infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening.
* Clinically significant findings on lab tests and/or hepatits B or C, or HIV screenings.
* Active TB requiring treatment within the previous 3 years.
* Evidence of active malignant disease, malignancies diagnosed within the previous 10 years, or breast cancer diagnosed within the previous 20 years.
* History of alcohol, drug, or chemical abuse within 1 year prior to Screening.
* Neuropathies or other conditions that might interfere with pain evaluation.
* Major surgery (including joint surgery) within 8 weeks prior to Screening or planned major surgery within 6 months following Baseline.
* Rheumatic autoimmune disease other than RA, including systemic lupus erythematosis, mixed connective tissue disorder, scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis or Felty's syndrome). Secondary Sjögren's syndrome with RA is permitted.
* Functional Class IV as defined by the ACR Classification of Functional Status in-Rheumatoid Arthritis (Appendix 2).
* Diagnosis of juvenile idiopathic arthritis or juvenile RA, and/or RA before the age of 16.
* Prior history of or current inflammatory joint disease other than RA.
* Previous exposure to RoActemra/Actemra (either IV or SC).
* Prior treatment with a biologic agent.
* Treatment with any investigational agent within 4 weeks (or five half-lives of the investigational drug, whichever is longer) of Screening.
* Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies, with alkylating agents such as chlorambucil, or with total lymphoid irradiation.
* Treatment with IV gamma globulin, plasmapheresis within 6 months of Baseline.
* Immunization with a live/attenuated vaccine within 4 weeks prior to Baseline.
18 Years
ALL
No
Sponsors
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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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Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
C. A. B. A., , Argentina
Córdoba, , Argentina
Rosario, , Argentina
Goiânia, Goiás, Brazil
Cuiabá, Mato Grosso, Brazil
Juiz de Fora, Minas Gerais, Brazil
Rio de Janeiro, Rio de Janeiro, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Bogota D.C., , Colombia
Bucaramanga, , Colombia
Medellín, , Colombia
Santo Domingo, , Dominican Republic
Mexico City, , Mexico
Mérida, , Mexico
Morelia, , Mexico
Maracaibo, , Venezuela
Punto Fijo, , Venezuela
Countries
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References
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Mysler E, Cardiel MH, Xavier RM, Lopez A, Ramos-Esquivel A. Subcutaneous Tocilizumab in Monotherapy or in Combination With Nonbiologic Disease-Modifying Antirheumatic Drugs in Latin American Patients With Moderate to Severe Active Rheumatoid Arthritis: A Multicenter, Phase IIIb Study. J Clin Rheumatol. 2020 Oct;26(7S Suppl 2):S180-S186. doi: 10.1097/RHU.0000000000001361.
Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Devenport J, Petho-Schramm A. Effects of concomitant glucocorticoids in TOZURA, a common-framework study programme of subcutaneous tocilizumab in rheumatoid arthritis. Rheumatology (Oxford). 2019 Jun 1;58(6):1056-1064. doi: 10.1093/rheumatology/key393.
Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Bernasconi C, Petho-Schramm A. Subcutaneous tocilizumab in rheumatoid arthritis: findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries. Rheumatology (Oxford). 2018 Mar 1;57(3):499-507. doi: 10.1093/rheumatology/kex443.
Other Identifiers
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ML28700
Identifier Type: -
Identifier Source: org_study_id