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This open-label single-arm study will evaluate the safety, tolerability and efficacy of tocilizumab [RoActemra/Actemra] in patients with moderate to severe rheumatoid arthritis who experience an inadequate clinical response to a stable dose of non-biologic disease modifying anti-rheumatic drugs (DMARD) or anti-tumor necrosis factors (TNFs). RoActemra/Actemra will be administered as a monotherapy or in combination with DMARDs. RoActemra/Actemra will be administered as intravenous infusion at a dose of 8 mg/kg every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tocilizumab [RoActemra/Actemra] | Drug | 8 mg/kg iv infusion, every 4 weeks for a total of 6 infusions |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting Any Adverse Event - Overall Summary of Events | Percentage of participants with a serious adverse event (SAE), who died, with an adverse event (AE), or study drug related AE during the study. | Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category | DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and global health assessment (participant rated global assessment of disease activity using 10-mm Visual analog scale - VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. A DAS28 score of greater than (>)5.1 indicated high disease activity, a score of >3.2 but less than or equal to (≤)5.1 indicated moderate disease activity, a score of greater than or equal to (≥)2.6 but ≤3.2 indicated low disease activity, and a score of less than <2.6 indicated disease remission. Week 24 is the Follow-Up visit. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manama | 12 | Bahrain | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Tocilizumab 8 Milligrams Per Kilogram (mg/kg) | Participants received tocilizumab 8 mg/kg intravenous (IV) infusion, once every 4 weeks for a total of 6 infusions. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline and Weeks 4, 8, 12, 16, 20, and 24 |
| Percentage of Participants Achieving a Clinically Meaningful Improvement as Measured by DAS28 | DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Participants achieved a clinically meaningful improvement in DAS28 if there was a reduction of at least 1.2 units from baseline. | Weeks 4, 8, 12, 16, 20, and 24 |
| Time to DAS28 Response by DAS28 Category | Time to response is the number of days from date of first infusion to date of event. DAS28 response was defined as achievement of Low Disease Activity (DAS28 ≥2.6 to ≤3.2), Remission (DAS28 <2.6), or Clinically Meaningful Improvement (change of >1.2 from baseline). | Weeks 4, 8, 12, 16, 20, and 24 |
| Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at Least 0.22 Units | HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. | Weeks 4, 8, 12, 16, 20, and 24 |
| Percentage of Participants With Improvement in Physical Function by HAQ-DI Category | Physical function scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. The HAQ-DI score at every visit was categorized into none to mild disability (HAQ-DI <1), moderate disability (1≤ HAQ-DI <2) and severe disability (HAQ-DI ≥2). The percentages of the participants falling in each of these categories with respect to the visits were determined. | Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
| HAQ-DI Score by Visit | HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.. | Baseline and Weeks 4, 8, 12, 16, 20, and 24 |
| C-Reactive Protein (CRP) Values by Study Visit | CRP is an acute phase inflammatory marker. The serum concentration of CRP is measured in milligrams per liter (mg/L). A reduction in the level is considered an improvement. | Baseline and Weeks 4, 8, 12, 16, 20, and 24 |
| Erythrocyte Sedimentation Rate | ESR (measured in mm/hr) is an inflammation marker used to determine acute phase response. | Baseline and Weeks 4, 8, 12, 16, 20, and 24 |
| Riffa |
| 28743 |
| Bahrain |
| Isfahan | 8174675731 | Iran |
| Tehran | 1333631151 | Iran |
| Tehran | 14114 | Iran |
| Safat | 13041 | Kuwait |
| Doha | 3050 | Qatar |
| Abu Dhabi | 51900 | United Arab Emirates |
| Abu Dhabi | United Arab Emirates |
| COMPLETED |
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| NOT COMPLETED |
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All the participants who were administered treatment at each visit were considered during the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tocilizumab 8 mg/kg | Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions. |
| 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 |
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| 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 | Percentage of Participants Reporting Any Adverse Event - Overall Summary of Events | Percentage of participants with a serious adverse event (SAE), who died, with an adverse event (AE), or study drug related AE during the study. | All the participants who were administered treatment at each visit were considered during the analysis. | Posted | Number | percentage of participants | Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24 |
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| Secondary | Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category | DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and global health assessment (participant rated global assessment of disease activity using 10-mm Visual analog scale - VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. A DAS28 score of greater than (>)5.1 indicated high disease activity, a score of >3.2 but less than or equal to (≤)5.1 indicated moderate disease activity, a score of greater than or equal to (≥)2.6 but ≤3.2 indicated low disease activity, and a score of less than <2.6 indicated disease remission. Week 24 is the Follow-Up visit. | All the participants who were administered treatment at each visit were considered during the analysis. n (number) at Week 24 equals (=) number of participants in that visit; n at Other Visits = number of participants with treatment administered | Posted | Number | percentage of participants | Baseline and Weeks 4, 8, 12, 16, 20, and 24 |
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| Secondary | Percentage of Participants Achieving a Clinically Meaningful Improvement as Measured by DAS28 | DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Participants achieved a clinically meaningful improvement in DAS28 if there was a reduction of at least 1.2 units from baseline. | All the participants who were administered treatment at each visit were considered during the analysis. n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered | Posted | Number | percentage of participants | Weeks 4, 8, 12, 16, 20, and 24 |
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| Secondary | Time to DAS28 Response by DAS28 Category | Time to response is the number of days from date of first infusion to date of event. DAS28 response was defined as achievement of Low Disease Activity (DAS28 ≥2.6 to ≤3.2), Remission (DAS28 <2.6), or Clinically Meaningful Improvement (change of >1.2 from baseline). | All the participants who were administered treatment at each visit were considered during the analysis. | Posted | Mean | Standard Error | days | Weeks 4, 8, 12, 16, 20, and 24 |
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| Secondary | Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at Least 0.22 Units | HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. | All the participants who were administered treatment at each visit were considered during the analysis. n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered | Posted | Number | percentage of participants | Weeks 4, 8, 12, 16, 20, and 24 |
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| Secondary | Percentage of Participants With Improvement in Physical Function by HAQ-DI Category | Physical function scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. The HAQ-DI score at every visit was categorized into none to mild disability (HAQ-DI <1), moderate disability (1≤ HAQ-DI <2) and severe disability (HAQ-DI ≥2). The percentages of the participants falling in each of these categories with respect to the visits were determined. | All the participants who were administered treatment at each visit were considered during the analysis. n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered | Posted | Number | percentage of participants | Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
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| Secondary | HAQ-DI Score by Visit | HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.. | All the participants who were administered treatment at each visit were considered during the analysis. n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Weeks 4, 8, 12, 16, 20, and 24 |
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| Secondary | C-Reactive Protein (CRP) Values by Study Visit | CRP is an acute phase inflammatory marker. The serum concentration of CRP is measured in milligrams per liter (mg/L). A reduction in the level is considered an improvement. | All the participants who were administered treatment at each visit were considered during the analysis. | Posted | Mean | Standard Deviation | mg/L | Baseline and Weeks 4, 8, 12, 16, 20, and 24 |
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| Secondary | Erythrocyte Sedimentation Rate | ESR (measured in mm/hr) is an inflammation marker used to determine acute phase response. | All the participants who were administered treatment at each visit were considered during the analysis. | Posted | Mean | Standard Deviation | mm/hr | Baseline and Weeks 4, 8, 12, 16, 20, and 24 |
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Adverse events data were collected from the date of first dose of study drug administration to the end of study at Week 24.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events. Note that available data included a summary of events by system organ class only, no data provided by preferred term.
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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 | Participants received tocilizumab 8 mg/kg iv infusion, every 4 weeks for a total of 6 infusions. | 8 | 95 | 43 | 95 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Investigations | Investigations | MedDRA | Systematic Assessment |
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| Musculoskeletal and connective tissue disorder | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Infection and infestation | Infections and infestations | MedDRA | Systematic Assessment |
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| Renal and urinary disorders | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Investigations | Investigations | MedDRA | Non-systematic Assessment |
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| Blood and lymphatic system disorders | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
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| Infections and infestations | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
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| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| General disorders and administration site conditions | General disorders | MedDRA | Non-systematic Assessment |
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| Nervous system disorders | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Respiratory, thoracic, and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Cardiac disorders | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Injury, poisoning, and procedural complications | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Renal and urinary disorders | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
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| Vascular disorders | Vascular disorders | MedDRA | Non-systematic Assessment |
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Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
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 after the first publication or presentation that involves the overall study. 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- LaRoche | 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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| Title | Measurements |
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| With any AE |
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| Title | Denominators | Categories | ||||
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| Baseline |
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| Week 4 |
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| Week 8 |
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| Week 24 |
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