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This observational study will evaluate the safety and efficacy of tocilizumab in participants with active moderate to severe RA and an inadequate response to non-biologic DMARDs. Data will be collected from each eligible participant initiating tocilizumab treatment over 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocilizumab in Moderate to Severe Active RA | Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official Summary of Product Characteristics (SPC), will be observed. The choice of therapy will be based exclusively on the medical decision of the treating physician before study enrollment. The study protocol does not enforce treatment initiation and also does not specify any treatment regimen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | Participants will receive tocilizumab treatment according to effective official SPC. The study protocol does not enforce treatment initiation and also does not specify any treatment regimen. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs include both SAEs as well as non-serious AEs. | Baseline up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria | EULAR response was based on 28-joint disease activity score (DAS28). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline (CFB) in DAS28 score and the level of disease activity reached (absolute DAS28 score). Good responders had a CFB greater than (>) 1.2 with a DAS28 score less than or equal to (<=) 3.2; moderate responders had a CFB >1.2 with a DAS28 score >3.2 to <= 5.1 or a change from baseline >0.6 to <= 1.2 with a DAS28 score <= 5.1; non-responders had a CFB <=0.6 or CFB >0.6 to <=1.2 with DAS28 >5.1. Number of participants who achieved EULAR good response and EULAR moderate response were reported. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with RA and an inadequate response to non-biologic DMARDs.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Podgorica | 81000 | Montenegro |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tocilizumab in Moderate to Severe Active RA | Moderate to severe active Rheumatoid Arthritis (RA) participants, receiving tocilizumab treatment according to effective official Summary of Product Characteristics (SPC), were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline, Week 24 |
| Number of Participants Who Discontinued Treatment Due to Lack of Efficacy | Baseline up to Week 24 |
| Time to Discontinuation Due to Lack of Efficacy | Baseline up to Week 24 |
| COMPLETED |
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| NOT COMPLETED |
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All participants who were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tocilizumab in Moderate to Severe Active RA | Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs include both SAEs as well as non-serious AEs. | All participants enrolled in the study. | Posted | Number | participants | Baseline up to Week 24 |
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| Secondary | Number of Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria | EULAR response was based on 28-joint disease activity score (DAS28). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline (CFB) in DAS28 score and the level of disease activity reached (absolute DAS28 score). Good responders had a CFB greater than (>) 1.2 with a DAS28 score less than or equal to (<=) 3.2; moderate responders had a CFB >1.2 with a DAS28 score >3.2 to <= 5.1 or a change from baseline >0.6 to <= 1.2 with a DAS28 score <= 5.1; non-responders had a CFB <=0.6 or CFB >0.6 to <=1.2 with DAS28 >5.1. Number of participants who achieved EULAR good response and EULAR moderate response were reported. | All participants enrolled in the study. | Posted | Number | participants | Baseline, Week 24 |
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| Secondary | Number of Participants Who Discontinued Treatment Due to Lack of Efficacy | All participants enrolled in the study. | Posted | Number | participants | Baseline up to Week 24 |
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| Secondary | Time to Discontinuation Due to Lack of Efficacy | As none of the participants discontinued treatment due to lack of efficacy, this outcome measure was not estimable. | Posted | Baseline up to Week 24 |
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Baseline up to Week 24
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tocilizumab in Moderate to Severe Active RA | Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen. | 0 | 50 | 38 | 50 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
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| Leukopenia with neutropenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
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| Gastralgia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Hepatic transaminases increased | Investigations | MedDRA | Non-systematic Assessment |
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| Oral herpes simplex | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Bronchopneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Fever | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Polyartralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Hypercholesterolemia with hypertriglyceridemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
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| Hypercholesterolemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| 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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