A Phase IV Study to Evaluate the Effect of Subcutaneous (SC) Tocilizumab Administered to Participants With Rheumatoid Arthritis (RA) Assessed Using Disease Activity Score (DAS28)
NCT ID: NCT02534311
Last Updated: 2018-02-28
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
60 participants
OBSERVATIONAL
2015-10-13
2015-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Tocilizumab
Participants will receive tocilizumab (162 milligrams \[mg\]) SC injection for 48 weeks.
Tocilizumab
Tocilizumab will be administered at 162 mg SC injection for 48 weeks.
Interventions
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Tocilizumab
Tocilizumab will be administered at 162 mg SC injection for 48 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with moderate to severe active RA (DAS28 \>=3.2) who did not respond sufficiently to or did not tolerate previous treatment with one or several disease-modifying antirheumatic drugs (DMARDs), irrespective of whether they were of biological or synthetic nature
* Participants eligible for the treatment with subcutaneously administered tocilizumab, as decided by the doctor in accordance with summary of product characteristics (SPC) and standard therapeutic procedures, who were not previously treated with tocilizumab and did not receive any other biological treatment for RA in the past either
* Assignment of participants for observation using the treatment described above is clearly separated from the physician's decision to prescribe the treatment to the patient.
* Pulmonologist's consent for chest X-ray and quantiferon test with commencement of biological treatment
Exclusion Criteria
* History of severe allergic or anaphylactic responses to human or humanized murine monoclonal antibodies
* History of intestinal ulcerations or diverticulitis
* Active hepatopathy with more than threefold increase of alanine transaminase (ALT) or aspartate transaminase (AST)
* Thrombocytes \<100,000 per cubic milliliters (/mm\^3), less than (\<) 3,000 mm\^3, absolute neutrophil count \< 2,000 mm\^3
* Women of childbearing age (without medically confirmed sterility, e.g. following hysterectomy, ovariectomy, menopause lasting 2 years) who do not accept the use of a suitable form of contraception (e.g. barrier methods of contraception in the participant and partner, contraceptive pills or patches, hormonal implants, spermicidal agents in combination with barrier method of contraception, intrauterine device)
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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Banská Bystrica, , Slovakia
Bratislava, , Slovakia
Bratislava, , Slovakia
Nitra, , Slovakia
Piešťany, , Slovakia
Countries
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Other Identifiers
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ML29712
Identifier Type: -
Identifier Source: org_study_id
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