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This multi-center, open-label, single-arm, Phase IIIb study will evaluate the safety and efficacy of subcutaneous RoActemra/Actemra alone or in combination with non-biologic disease modifying antirheumatic drugs (DMARDs) in rheumatoid arthritis patients in Latin America with an inadequate response to non-biologic DMARDs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RoActemra/Actemra | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tocilizumab [RoActemra/Actemra] | Drug | 162 mg will be administered once weekly by subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) Remission Rate | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events (AE) | 60 weeks | |
| Efficacy: Change in DAS28-ESR | From baseline to Week 52 | |
| Efficacy: ACR/EULAR responses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buenos Aires | C1015ABO | Argentina | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32251060 | Derived | 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. | |
| 30649524 |
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| 52 weeks |
| Efficacy: Change in disease activity (CDAI/SDAI) | From baseline to Week 52 |
| Efficacy: Change in joint swelling/tenderness (SJC/TJC) | From baseline to Week 52 |
| Safety: Assessment of immunogenicity | 60 weeks |
| Patient-reported outcomes | 60 weeks |
| Efficacy: DAS28-ESR Remission Rate | 52 weeks |
| Efficacy: Proportion of patients who maintain DAS28 Remission/LDA | From Week 24 to Week 52 |
| Safety: Rates of AE leading to dose modification or study withdrawal | 52 weeks |
| Safety: Assessment of physical examination and vital signs | 52 weeks |
| Safety: Incidence of clinically significant laboratory abnormalities following treatment | 52 weeks |
| Buenos Aires |
| C1426AAL |
| Argentina |
| Buenos Aires | C1428DQG | Argentina |
| C. A. B. A. | C1055AAF | Argentina |
| Córdoba | 5000 | Argentina |
| Rosario | S2000PBJ | Argentina |
| Goiânia | Goiás | 74110010 | Brazil |
| Cuiabá | Mato Grosso | 78025-000 | Brazil |
| Juiz de Fora | Minas Gerais | 36036-330 | Brazil |
| Rio de Janeiro | Rio de Janeiro | 20950-000 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90035-170 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| São Paulo | São Paulo | 01244-030 | Brazil |
| São Paulo | São Paulo | 04026-000 | Brazil |
| São Paulo | São Paulo | 05437-010 | Brazil |
| Bogota D.C. | Colombia |
| Bucaramanga | Colombia |
| Medellín | Colombia |
| Santo Domingo | 10208 | Dominican Republic |
| Mexico City | 06726 | Mexico |
| Mérida | 97000 | Mexico |
| Morelia | 58070 | Mexico |
| Maracaibo | 4001 | Venezuela |
| Punto Fijo | 4102 | Venezuela |
| Derived |
| 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. |
| 29244149 | Derived | 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. |
| 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 |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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