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This single arm, open label study will assess the safety and efficacy, with regard to reduction of signs and symptoms,of treatment with tocilizumab in patients with moderate to severe active rheumatoid arthritis. Patients will receive tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions. Patients already receiving methotrexate at entry into the study may continue with their treatment together with tocilizumab.The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tocilizumab [RoActemra/Actemra] | Drug | 8mg/kg iv every 4 weeks for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20 Response) at Week 24 | ACR20 response: greater than or equal to (≥) 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (visual analog scale [VAS]), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) erythrocyte sedimentation rate (ESR) at each visit. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) at Week 24 | ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (VAS), 4) participant assessment of functional disability via a HAQ, and 5) ESR at each visit. |
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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 |
|---|---|---|---|---|---|---|
| Alabang Medical Center | City of Muntinlupa | 1770 | Philippines | |||
| Manila Doctors Hospital; Rheumatology Section |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tocilizumab 8 Milligrams Per Kilogram (mg/kg) | Participants received tocilizumab 8 mg/kg intravenously (IV) once every 4 weeks for 24 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety population included all participants who received any part of an infusion of study drug.
Intent to Treat (ITT) Population was used for efficacy analyses. All participants who have received any part of an infusion of study medication were included in this population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tocilizumab 8 mg/kg | Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Achieving American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20 Response) at Week 24 | ACR20 response: greater than or equal to (≥) 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (visual analog scale [VAS]), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) erythrocyte sedimentation rate (ESR) at each visit. | ITT population | Posted | Number | percentage of participants | Week 24 |
|
Adverse events were recorded from the date of screening until 4 weeks after the last infusion.
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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 8 mg/kg | Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated AST/SGOT level | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann- LaRoche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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| Week 24 |
| Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) at Week 24 | ACR70 response: ≥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (VAS), 4) participant assessment of functional disability via a HAQ, and 5) ESR at each visit. | Week 24 |
| HAQ Disability Index (HAQ-DI) Score at Baseline and Week 24 | HAQ-DI is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To calculate HAQ-DI the participant must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). | Baseline and Week 24 |
| Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Baseline and Week 24 | FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participants response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the health status. | Baseline and Week 24 |
| Disease Activity Score Based on 28 Joint Count - Erythrocyte Sedimentation Rate (DAS28-ESR) at Baseline and Week 24 | DAS28-ESR calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (millimeters per hour [mm/hour]) and Patient's Global Assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity. | Baseline and Week 24 |
| Percentage of Participants With Disease Remission at Week 24 Assessed Using DAS28-ESR | DAS28-ESR calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hour) and Patient's Global Assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 <2.6=remission. | Week 24 |
| Percentage of Participants With Low Disease Activity at Week 24 Assessed Using DAS28-ESR | DAS28-ESR calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hour) and Patient's Global Assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 >2.6 and <3.2=low disease activity. | Week 24 |
| Time to Onset of ACR20/50/70 Response | Time to onset of ACR 20/50/70 response was calculated as the number of weeks from the administration of the first dose of study drug until the date of first achievement of ACR 20/50/70 per criteria. | Weeks 4, 8, 12, 16, 20, and 24 |
| Manila |
| 1000 |
| Philippines |
| Jose Reyes Memorial Medical Center | Manila | 1003 | Philippines |
| Our Lady of Mount Carmel Medical Center | San Fernando City | 2000 | Philippines |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) at Week 24 | ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (VAS), 4) participant assessment of functional disability via a HAQ, and 5) ESR at each visit. | ITT Population | Posted | Number | percentage of participants | Week 24 |
|
|
|
| Secondary | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) at Week 24 | ACR70 response: ≥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (VAS), 4) participant assessment of functional disability via a HAQ, and 5) ESR at each visit. | ITT Population | Posted | Number | percentage of participants | Week 24 |
|
|
|
| Secondary | HAQ Disability Index (HAQ-DI) Score at Baseline and Week 24 | HAQ-DI is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To calculate HAQ-DI the participant must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). | ITT Population | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 24 |
|
|
|
|
| Secondary | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Baseline and Week 24 | FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participants response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the health status. | ITT Population | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 24 |
|
|
|
|
| Secondary | Disease Activity Score Based on 28 Joint Count - Erythrocyte Sedimentation Rate (DAS28-ESR) at Baseline and Week 24 | DAS28-ESR calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (millimeters per hour [mm/hour]) and Patient's Global Assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity. | ITT Population | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 24 |
|
|
|
|
| Secondary | Percentage of Participants With Disease Remission at Week 24 Assessed Using DAS28-ESR | DAS28-ESR calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hour) and Patient's Global Assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 <2.6=remission. | ITT Population | Posted | Number | percentage of participants | Week 24 |
|
|
|
| Secondary | Percentage of Participants With Low Disease Activity at Week 24 Assessed Using DAS28-ESR | DAS28-ESR calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hour) and Patient's Global Assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 >2.6 and <3.2=low disease activity. | ITT Population | Posted | Number | percentage of participants | Week 24 |
|
|
|
| Secondary | Time to Onset of ACR20/50/70 Response | Time to onset of ACR 20/50/70 response was calculated as the number of weeks from the administration of the first dose of study drug until the date of first achievement of ACR 20/50/70 per criteria. | ITT Population | Posted | Median | Inter-Quartile Range | weeks | Weeks 4, 8, 12, 16, 20, and 24 |
|
|
|
| 1 |
| 29 |
| 24 |
| 29 |
| Elevated ALT/SGPT level | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Elevated AST ad ALT levels | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Urinary tract infection (UTI) | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Systemic viral infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Hypercholesterolemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Fatty liver | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Colonic diverticulitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Internal hemorrhoids, grade 1 | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Non ulcer dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Pruritic back | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Pruritic, erythematous scaly plaques over interdigital areas (right foot, first-third toes) | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Rashes on chest: back | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Rashes on toes | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Erythematous, pruritic maculopapular rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Contact dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Carpal tunnel syndrome (R) | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Trigger finger 4th digit left hand | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Uterine myoma with nabothian cysts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Paresthesia at the palm of infusion | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Knee effusion | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Chills and increased pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Headache/back pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Fever and headache | General disorders | MedDRA | Non-systematic Assessment |
|
| Cough productive due to infection | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Acute pharyngitis probably viral etiology | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Dengue | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Folliculitis left ear | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
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.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|
|