Non-Interventional Study of Tocilizumab Subcutaneous (SC) Monotherapy in Participants With Rheumatoid Arthritis (RA)
NCT ID: NCT02402686
Last Updated: 2019-12-06
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
353 participants
OBSERVATIONAL
2015-05-20
2018-12-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Tocilizumab for RA in Routine Clinical Practice
Participants from routine clinical practice in Hungary who are receiving treatment for RA with tocilizumab SC according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling and who have no contraindication to tocilizumab therapy as per the local label are eligible for observation.
Tocilizumab
Dosing and treatment duration of tocilizumab collected as part of this non-interventional study are at the discretion of the physician in accordance with local clinical practice and local labeling. Observation period is 24 weeks from first SC tocilizumab administration.
Interventions
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Tocilizumab
Dosing and treatment duration of tocilizumab collected as part of this non-interventional study are at the discretion of the physician in accordance with local clinical practice and local labeling. Observation period is 24 weeks from first SC tocilizumab administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treatment with tocilizumab SC monotherapy for up to 8 weeks prior to enrollment, under the prescriptive authority of a physician who has made the decision to commence tocilizumab in accordance with the local label
* Methotrexate intolerance, or inadequate response to prior DMARDs and TNF inhibitors where continued methotrexate treatment was deemed inappropriate
Exclusion Criteria
* Failure to meet local tocilizumab label indication criteria
* Treatment with any investigational agent within 4 weeks of beginning tocilizumab SC monotherapy
* Last methotrexate dose within 1 week of beginning tocilizumab SC monotherapy
* History of any other autoimmune or joint inflammatory disease
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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National Institute of Rheumatology and Physiotherapy; 4Th Rheumatology Department
Budapest, , Hungary
Budai Irgalmasrendi Kórház KHT. II. Reumatológia
Budapest, , Hungary
Magyar Honvedseg Honved Korhaz, Reumatologia
Budapest, , Hungary
Debreceni Egyetem Orvos- és Egészségtudományi Centrum; Belgyógyászati Intézet, Reumatológiai Tanszék
Debrecen, , Hungary
Markhot Ferenc Hospital; Dep. of Rheumatology
Eger, , Hungary
Vaszary Kolos Kórház
Esztergom, , Hungary
Petz Aladár County Teaching Hospital
Győr, , Hungary
Pandy Kalman Hospital; Dept. of Infectious Diseases
Gyula, , Hungary
Szent Andras Reumakorhaz; Reumatologia
Hévíz, , Hungary
Bacs-Kiskun Megyei Korhaz
Kecskemét, , Hungary
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, , Hungary
Szent Ferenc Kórház; Reumatológia
Miskolc, , Hungary
Szabolcs-Szatmar-Bereg Megyei Josa Andras Korhaz; Reumatologia
Nyíregyháza, , Hungary
Pécsi Tudományegyetem Klinikai Központ: Immunológiai és Reumatológiai Klinika
Pécs, , Hungary
Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont; Rheumatologiai Klinika
Szeged, , Hungary
Fejér Megyei Szent György Kórház; Reumatológiai Osztály
Székesfehérvár, , Hungary
Markusovszky Hospital
Szombathely, , Hungary
Veszprém Megyei Csolnoky Ferenc Kórház; Reumatológia
Veszprém, , Hungary
Countries
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References
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Nagy G, Geher P, Tamasi L, Drescher E, Keszthelyi P, Pulai J, Czirjak L, Szekanecz Z, Kiss G, Kovacs L. Real-world evidence on methotrexate-free subcutaneous tocilizumab therapy in patients with rheumatoid arthritis: 24-week data from the SIMPACT study. Rheumatol Adv Pract. 2022 May 16;6(2):rkac038. doi: 10.1093/rap/rkac038. eCollection 2022.
Other Identifiers
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ML29719
Identifier Type: -
Identifier Source: org_study_id
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