Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this non-interventional study in Hungarian participants is to gather real life data about the efficacy and safety of tocilizumab SC monotherapy in RA, to assess data about pattern of usage of tocilizumab monotherapy in RA disease management.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Disease Activity Score 28 (DAS28) from Baseline to End of Study | Baseline, end of study (up to 24 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Disease Activity Index (CDAI) Score from Baseline to End of Study | Baseline, end of study (up to 24 weeks) | |
| Percentage of Participants Achieving DAS28 Remission, as Defined by DAS28 Less Than or Equal to (≤) 2.6 | Up to 24 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Participants receiving treatment for RA with tocilizumab SC according to standard of care and in line with the current SPC/local labeling and who have no contraindication to tocilizumab therapy as per the local label. This can include participants who have received tocilizumab SC monotherapy treatment within 8 weeks prior to the enrollment visit.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Rheumatology and Physiotherapy; 4Th Rheumatology Department | Budapest | 1023 | Hungary | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35663154 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Percentage of Participants Achieving CDAI Remission, as Defined by CDAI ≤2.8 | Up to 24 weeks |
| Change in DAS28 from Baseline to End of Study in Different Monotherapy Subgroups | The following 3 monotherapy subgroups will be included: 1) participants starting tocilizumab after failing disease-modifying antirheumatic drugs (DMARDs), 2) participants starting tocilizumab after failing one biologic, 3) participants starting tocilizumab after failing two or more biologics. | Baseline, end of study (up to 24 weeks) |
| Percentage of Participants Achieving DAS28 Remission in Different Monotherapy Subgroups, as Defined by DAS28 ≤2.6 | The following 3 monotherapy subgroups will be included: 1) participants starting tocilizumab after failing DMARDs, 2) participants starting tocilizumab after failing one biologic, 3) participants starting tocilizumab after failing two or more biologics. | Up to 24 weeks |
| Number of Tocilizumab SC Injections per Participant During Observational Treatment Period | Up to 24 weeks |
| Percentage of Participants Who Discontinued Tocilizumab, Categorized by the Reasons for the Discontinuations | Up to 24 weeks |
| Percentage of Participants on SC Tocilizumab First Line Monotherapy | Up to 24 weeks |
| Percentage of Participants with Reasons for SC Tocilizumab Monotherapy | Up to 24 weeks |
| Percentage of Participants Treated Previously with a Tumor Necrosis Factor (TNF) Inhibitor/Other Biologic and Low Dose Methotrexate (Less Than 10 Milligrams/Week) | Up to 24 weeks |
| Percentage of Participants with Other DMARDs Than Methotrexate Before Tocilizumab Monotherapy Initiation and at End of Observation Period | Baseline, Week 24 |
| Percentage of Participants with Oral Steroid at Initiation of Tocilizumab SC Therapy and at End of Study | Baseline, Week 24 |
| Percentage of Participants With Steroid Dose Reductions/Withdrawal at End of Observation Period | Week 24 |
| Percentage of Participants with Steroid Tapering in Different Monotherapy Subgroups Who Achieved DAS28 Remission | The following 3 monotherapy subgroups will be included: 1) participants starting tocilizumab after failing DMARDs, 2) participants starting tocilizumab after failing one biologic, 3) participants starting tocilizumab after failing two or more biologics. | Up to 24 weeks |
| Percentage of Participants with Adverse Events | Up to 24 weeks |
| Budai Irgalmasrendi Kórház KHT. II. Reumatológia |
| Budapest |
| 1027 |
| Hungary |
| Magyar Honvedseg Honved Korhaz, Reumatologia | Budapest | 1062 | Hungary |
| Debreceni Egyetem Orvos- és Egészségtudományi Centrum; Belgyógyászati Intézet, Reumatológiai Tanszék | Debrecen | 4032 | Hungary |
| Markhot Ferenc Hospital; Dep. of Rheumatology | Eger | 3300 | Hungary |
| Vaszary Kolos Kórház | Esztergom | 2500 | Hungary |
| Petz Aladár County Teaching Hospital | Győr | 9023 | Hungary |
| Pandy Kalman Hospital; Dept. of Infectious Diseases | Gyula | 5700 | Hungary |
| Szent Andras Reumakorhaz; Reumatologia | Hévíz | 8380 | Hungary |
| Bacs-Kiskun Megyei Korhaz | Kecskemét | 6000 | Hungary |
| Pest Megyei Flor Ferenc Korhaz | Kistarcsa | 2084 | Hungary |
| Szent Ferenc Kórház; Reumatológia | Miskolc | 3529 | Hungary |
| Szabolcs-Szatmar-Bereg Megyei Josa Andras Korhaz; Reumatologia | Nyíregyháza | 4400 | Hungary |
| Pécsi Tudományegyetem Klinikai Központ: Immunológiai és Reumatológiai Klinika | Pécs | 7632 | Hungary |
| Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont; Rheumatologiai Klinika | Szeged | 6724 | Hungary |
| Fejér Megyei Szent György Kórház; Reumatológiai Osztály | Székesfehérvár | 8000 | Hungary |
| Markusovszky Hospital | Szombathely | 9700 | Hungary |
| Veszprém Megyei Csolnoky Ferenc Kórház; Reumatológia | Veszprém | 8200 | Hungary |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C502936 | tocilizumab |
Not provided
Not provided
Not provided