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The study was stopped prematurely due to lack of enrollment.
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This randomized, open-label, parallel-group study will assess the effect on disease remission of RoActemra/Actemra (tocilizumab) in combination with disease-modifying antirheumatic drugs (DMARDs) versus current best practice non-biologic DMARD therapy in patients with moderate-to-severe active rheumatoid arthritis. Patients who are randomly assigned to the RoActemra/Actemra treatment group will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on study treatment is 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tocilizumab [RoActemra/Actemra] | Drug | 8 mg/kg intravenously every 4 weeks plus background DMARDs (including methotrexate) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Disease Remission at Month 12 Assessed Using the Disease Activity Score Based on 28-Joint Count (DAS28) | The DAS28 is a combined index for measuring disease activity in Rheumatoid Arthritis (RA). The index includes swollen and tender joint counts (SJC and TJC), acute phase response, and general health status. For this study Erythrocyte sedimentation Rate (ESR) was to be used to calculate DAS28 score. The DAS28, which uses a 28 joint count, is derived from the original DAS which includes a 44 swollen joint count. The DAS28 has been validated in RA. The index is calculated using the following formula: DAS28 equals (=) 0.56 times (×) square root of √(TJC) plus (+) 0.28 × √(SJC) + 0.70 × ln(ESR) + 0.014 × GH Where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, ESR measured as millimeters per hour (mm/hr), and GH = general health, which is participant's global assessment of disease activity (100-mm Visual Analog Scale [VAS]). DAS28 less than/equal to (≤) 2.6 defined remission. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Hours Absent From Work | Work productivity measures include absence from work (participant reported and registries), permanent work disability (pension, participant reported and registries), presenteeism (Quantity and Quality instrument, QQ). | Baseline and 6 and 12 months |
| Percentage of Participants Achieving Disease Remission at Month 6 Assessed Using DAS28 |
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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 |
|---|---|---|---|---|---|---|
| Hämeenlinna | 13530 | Finland | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Tocilizumab | Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously every 4 weeks along with background disease-modifying antirheumatic drugs (DMARDs) including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| DMARD | Drug | Non-biologic DMARDs (including methotrexate) according to current best practice |
|
The DAS28 is a combined index for measuring disease activity in RA. The index includes SJC and TJC, acute phase response, and general health status. For this study ESR was to be used to calculate DAS28 score. The DAS28, which uses a 28 joint count, is derived from the original DAS which includes a 44 swollen joint count. The DAS28 has been validated in RA. The index is calculated using the following formula: DAS28 = 0.56 × √(TJC) + 0.28 × √(SJC) + 0.70 × ln(ESR) + 0.014 × GH Where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, ESR measured as millimeters per hour (mm/hr), and GH = general health, which is participant's global assessment of disease activity (100-mm VAS). DAS28 ≤ 2.6 defined remission. |
| Month 6 |
| Percentage of Participants Achieving Responses According to American College of Rheumatology (ACR) Criteria | The ACR definition of response includes tender and swollen joint counts, VAS scales for pain, participant and investigator global assessment of disease activity, participant-assessed disability using Health Assessment Questionnaire (HAQ) and acute phase response. | Months 6 and 12 |
| Percentage of Participants Achieving Remission at Months 6 and 12 Assessed Using Clinical Activity Disease Index (CDAI) | The CDAI is a purely clinical index to measure disease activity. The index includes swollen and tender joint counts, participant global assessment of disease activity, and evaluator global assessment of disease activity (EGA). | Months 6 and 12 |
| Change From Baseline to Months 6 and 12 in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT F) Scores | The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. 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 participant's response to the questions (with the exception of 2 negatively stated), the greater the participants 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 participant's 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). Clinically relevant improvement is defined as a ≥5-point change from Baseline. | Baseline and Months 6 and 12 |
| Change From Baseline to Months 6 and 12 in European Quality of Life-5D (EQ-5D) Score | EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. | Baseline and Months 6 and 12 |
| Change From Baseline to Months 6 and 12 in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | HAQ-DI 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. Overall score was computed as the sum of the domain scores and divided by the number of domains answered. Total possible score range was 0-3 where 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. | Baseline and Months 6 and 12 |
| Helsinki |
| 00029 |
| Finland |
| Jyväskylä | 40620 | Finland |
| Kuopio | 70101 | Finland |
| Riihimäki | 11101 | Finland |
| Rovaniemi | 96101 | Finland |
| Non-biologic DMARDs |
Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly. |
| COMPLETED |
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| NOT COMPLETED |
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|
Due to limited number of participants (n=2) the study was prematurely terminated.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tocilizumab | Participants received tocilizumab 8 mg/kg intravenously every 4 weeks plus background DMARDs (including methotrexate) |
| BG001 | Placebo | Participants received Non-biologic DMARDs (including methotrexate) according to current best practice |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
|
| 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 Disease Remission at Month 12 Assessed Using the Disease Activity Score Based on 28-Joint Count (DAS28) | The DAS28 is a combined index for measuring disease activity in Rheumatoid Arthritis (RA). The index includes swollen and tender joint counts (SJC and TJC), acute phase response, and general health status. For this study Erythrocyte sedimentation Rate (ESR) was to be used to calculate DAS28 score. The DAS28, which uses a 28 joint count, is derived from the original DAS which includes a 44 swollen joint count. The DAS28 has been validated in RA. The index is calculated using the following formula: DAS28 equals (=) 0.56 times (×) square root of √(TJC) plus (+) 0.28 × √(SJC) + 0.70 × ln(ESR) + 0.014 × GH Where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, ESR measured as millimeters per hour (mm/hr), and GH = general health, which is participant's global assessment of disease activity (100-mm Visual Analog Scale [VAS]). DAS28 less than/equal to (≤) 2.6 defined remission. | Because of the limited number (n) of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed. | Posted | Month 12 |
|
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| Secondary | Number of Hours Absent From Work | Work productivity measures include absence from work (participant reported and registries), permanent work disability (pension, participant reported and registries), presenteeism (Quantity and Quality instrument, QQ). | Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed. | Posted | Baseline and 6 and 12 months |
|
| ||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Disease Remission at Month 6 Assessed Using DAS28 | The DAS28 is a combined index for measuring disease activity in RA. The index includes SJC and TJC, acute phase response, and general health status. For this study ESR was to be used to calculate DAS28 score. The DAS28, which uses a 28 joint count, is derived from the original DAS which includes a 44 swollen joint count. The DAS28 has been validated in RA. The index is calculated using the following formula: DAS28 = 0.56 × √(TJC) + 0.28 × √(SJC) + 0.70 × ln(ESR) + 0.014 × GH Where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, ESR measured as millimeters per hour (mm/hr), and GH = general health, which is participant's global assessment of disease activity (100-mm VAS). DAS28 ≤ 2.6 defined remission. | Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed. | Posted | Month 6 |
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| Secondary | Percentage of Participants Achieving Responses According to American College of Rheumatology (ACR) Criteria | The ACR definition of response includes tender and swollen joint counts, VAS scales for pain, participant and investigator global assessment of disease activity, participant-assessed disability using Health Assessment Questionnaire (HAQ) and acute phase response. | Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed. | Posted | Months 6 and 12 |
|
| ||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Remission at Months 6 and 12 Assessed Using Clinical Activity Disease Index (CDAI) | The CDAI is a purely clinical index to measure disease activity. The index includes swollen and tender joint counts, participant global assessment of disease activity, and evaluator global assessment of disease activity (EGA). | Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed. | Posted | Months 6 and 12 |
|
| ||||||||||||||||||||||
| Secondary | Change From Baseline to Months 6 and 12 in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT F) Scores | The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. 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 participant's response to the questions (with the exception of 2 negatively stated), the greater the participants 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 participant's 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). Clinically relevant improvement is defined as a ≥5-point change from Baseline. | Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed. | Posted | Baseline and Months 6 and 12 |
| |||||||||||||||||||||||
| Secondary | Change From Baseline to Months 6 and 12 in European Quality of Life-5D (EQ-5D) Score | EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. | Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed. | Posted | Baseline and Months 6 and 12 |
| |||||||||||||||||||||||
| Secondary | Change From Baseline to Months 6 and 12 in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | HAQ-DI 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. Overall score was computed as the sum of the domain scores and divided by the number of domains answered. Total possible score range was 0-3 where 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. | Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed. | Posted | Baseline and Months 6 and 12 |
|
The study was terminated prematurely due to lack of enrollment. Adverse events were recorded from the date of screening until study termination.
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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 intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly. | 0 | 1 | 1 | 1 | ||
| EG001 | Non-biologic DMARDs | Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly. | 0 | 1 | 0 | 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastointestinal Disorder | Gastrointestinal disorders | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann- LaRoche | 1-800-821-8590 | 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 |
| D018501 | Antirheumatic Agents |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Male |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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