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| Name | Class |
|---|---|
| Clalit Health Services | OTHER |
This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra in patients with rheumatoid arthritis who have had an inadequate response (or were intolerant to) treatment with non-biological DMARDs or with one biological agent. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for 6 months from start of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants on TCZ Treatment at 6 Months After Treatment Initiation | 6 months | |
| Percentage of Participants on TCZ Treatment at 5-6 Months After Treatment Initiation | 5-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Systemic Manifestations of RA at Baseline | Systemic manifestations included fibromyalgia, osteoporosis, sjogren's syndrome, anemia, rheumatoid nodules, pulmonary fibrosis, vasculitis, peripheral neuropathy or mononeuropathy, scleritis, episcleritis, hypertension, hyperlipidemia, low high-density lipoproteins, diabetes type 1 and type 2, metabolic syndrome, carotid artery disease, transient ischemic attacks, embolic stroke, atherothrombotic stroke, atrial fibrillation, heart failure New York Heart Association (NYHA) Class l/ll, coronary heart disease(angina pectoris/myocardial), aortic aneurism, peripheral arterial occlusive disease, percutaneous coronary interventions, coronary artery bypass, carotid endarterectomy and peripheral arterial bypass. |
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Inclusion Criteria:
Exclusion Criteria:
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Rheumatoid arthritis patients treated with tocilizumab
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Afula | 18101 | Israel | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Rheumatoid Arthritis Participants | Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), who have had an inadequate response (or were intolerant) to treatment with non-biological disease-modifying anti-rheumatic drugs (DMARDs) or with one biological agent in whom the attending physician decided to start treatment with tocilizumab (TCZ) (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set (FAS) population included all recruited participants who received at least one dose of TCZ.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rheumatoid Arthritis Participants | Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months. |
| 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 on TCZ Treatment at 6 Months After Treatment Initiation | FAS population | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
|
Up to 6 months
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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 | Rheumatoid Arthritis Participants | Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who had been receiving TCZ in the past and in whom the attending physician decided to start treatment with TCZ at the time of recruitment (according to the local label) were observed for 6 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.1) | 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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| Baseline |
| Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study | DMARDs exposure was evaluated for all participants. "Prior DMARDs treatment" included participants, who were treated with DMARDs 8 weeks and according to physician's discretion before being included in the study. "DMARDs treatment at baseline" included participants who were receiving DMARDs when they were included in the study and continued with this concomitant medication in addition to TCZ. Only those participants who received DMARDs prior to start of study and at Baseline up to 6 months were reported. | Prior to study start (8 weeks) and Baseline up to 6 months |
| Percentage of Participants With Reason for DMARD Withdrawal | Objective intolerance was determined by medical observation; subjective intolerance was determined by the participant; lack of efficacy was determined by physician discretion. | Up to 6 months |
| Percentage of Participants Who Received Biological RA Treatment Prior to Start of Study | Biological RA treatment exposure was evaluated for all participants. "Prior biological RA treatment" included participants who were treated with biological RA treatment 8 weeks before being included in the study. Percentage of participants who did not receive any biological RA treatment and percentage of participants who received one or more biologic RA treatments were reported. | Prior to study start (8 weeks) |
| Percentage of Participants With Type of Previous Biologic RA Treatments | Previous biologic RA treatment included adalimumab, infliximab, golimumab, etanercept, certolizumab, and other (any other previous biologic RA treatment). Same participants may be counted in more than one previous biologic RA treatment category. | Up to 6 months |
| Duration of Previous Biologic RA Treatments | Previous biologic RA treatment included adalimumab, infliximab, golimumab, etanercept, certolizumab, and other (any other previous biologic RA treatment). | Up to 6 months |
| Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments | Lack of efficacy was determined by physician discretion. Previous biologic RA treatment included adalimumab, infliximab, golimumab, etanercept, certolizumab, and other (any other previous biologic RA treatment). | Up to 6 months |
| Percentage of Participants With Dose Modifications | TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. | 6 months |
| Percentage of Participants With Reasons for Dose Modification | TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. Only those participants who had dose modifications were reported. | 6 months |
| Mean Dose at 6 Months | TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. | 6 months |
| Mean Number of Dose Modifications at 6 Months | TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. | 6 months |
| Mean Dosing Interval of Treatment at 6 Months | TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. The mean dosing interval between different TCZ administrations (Adm) by participants within 6 months observational period was presented. | 6 months |
| Percentage of Participants Who Discontinued From TCZ for Safety Versus Efficacy | The safety variable measured the number of participants who discontinued TCZ due to adverse reactions to TCZ, and the efficacy variable measured the participants who discontinued from TCZ due to lack of efficacy according to criteria of the treating physician. | 6 months |
| Time to Restoration of Initial Dosing Regimen | 6 months |
| Percentage of Participants Who Adhered to the Dosing Regimen Recommended by Physician | A participant's adherence was calculated based on the adverse event or laboratory abnormality experienced by the participants who required dose modifications as per local TCZ label or protocol. | 6 months |
| Percentage of Participants on TCZ Monotherapy | TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. Only those participants who had TCZ as monotherapy were reported. | Up to 6 months |
| Change From Baseline in Tender Joint Count (TJC) (68 Joints) at Month 6 | The number of tender joints was recorded on the joint assessment form, with no tenderness = 0, and tenderness = 1, for 68 joints, giving a total possible TJC score of 0 to 68. | Baseline, 6 months |
| Change From Baseline in Swollen Joint Count (SJC) (66 Joints) at Month 6 | The number of swollen joints was recorded on the joint assessment form, with no swelling = 0, and swelling =1, for 66 joints, giving a total possible SJC score of 0 to 66. | Baseline, 6 months |
| Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) at Month 6 | DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [mm/hr]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission. | Baseline, 6 months |
| Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6 | Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH (mm), and ESR (mm/hr). DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement. EULAR Good response: DAS28 <=3.2 and a CFB <-1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a CFB < -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB >=-0.6, DAS28 >3.2 to <=5.1 or CFB >=-0.6 and DAS28 >5.1 or CFB >=-0.6. | 6 months |
| Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 6 | The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician's global assessment (PhGH) of disease activity, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP) (milligrams per deciliter [mg/dL]). SDAI total score = 0-86. A SDAI score of <=3.3 represented clinical remission, a score of <=11.0 represents low disease activity, a score of <=26.0 represented moderate disease activity and a score of >26.0 represented high (or severe) disease. | Baseline, 6 months |
| Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 6 | The CDAI was a combined index for measuring disease activity in RA and used to evaluate disease activity in the absence of laboratory testing of CRP and ESR. It was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH (assessed on 0-100 mm); VAS (0 = no disease activity and 100 = worst disease activity). CDAI total score = 0-76. A CDAI score of <=2.8 represented clinical remission, a score of <=10.0 represented low disease activity, a score of <=22.0 represented moderate disease activity and a score of >22.0 represented high (or severe) disease. | Baseline, 6 months |
| Percentage of Participants Who Achieved 20% Improvement in ACR (ACR20) Response at Month 6 | ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement. | 6 months |
| Percentage of Participants Who Achieved 50% Improvement in ACR (ACR50) Response at Month 6 | ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR50 response required at least a 50% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement. | 6 months |
| Percentage of Participants Who Achieved 70% Improvement in ACR (ACR70) Response at Month 6 | ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR70 response required at least a 70% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement. | 6 months |
| Change From Baseline in CRP at Month 6 | The test for CRP was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. The serum concentration of CRP was measured in mg/dL. A reduction in the level was considered an improvement. | Baseline, 6 months |
| Change From Baseline in ESR at Month 6 | ESR was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. ESR was measured in mm/hr. A reduction in the level was considered an improvement. | Baseline, 6 months |
| Change From Baseline in PhGH at Month 6 | The PhGH was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equaled 0 mm, and was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equaled 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from baseline indicated improvement. | Baseline, 6 months |
| Change From Baseline in PGH of Disease Activity at Month 6 | The PGH of disease activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equaled 0 mm, and was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equaled 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from baseline indicated improvement. | Baseline, 6 months |
| Change From Baseline in HAQ-DI at Month 6 | The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant's functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from "no difficulty" to "unable to do", corresponding to scores from 0 to 3. The HAQ-DI scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity. A score of <0.5 represented clinical remission. A participant achieved a clinically meaningful improvement in HAQ-DI if they had a reduction from baseline of >=0.22. | Baseline, 6 months |
| Change From Baseline in Participant's Assessment of Fatigue Using VAS at Month 6 | Fatigue was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the level of fatigue that they have experienced, ranging from 0 (no fatigue) to 100 (extreme fatigue). | Baseline, 6 months |
| Change From Baseline in Participant's Assessment of RA-Related Pain at Month 6 | Severity of pain was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the severity of pain that they had experienced because of their RA, ranging from 0 (no pain) to 100 (unbearable pain). A decrease of 10 points was considered clinically meaningful. | Baseline, 6 months |
| Change From Administration 1 in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Questionnaire at Month 6 | The FACIT Measurement System was a collection of health-related quality of life questionnaires targeted to the management of chronic illness and included questions on Physical Well-Being, Social/Family Well-Being, Emotional Well-Being and Functional Well-Being. The FACIT Fatigue Scale was a 13-item tool that measured an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue was measured on a five-point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score of FACIT ranged from 0 to 160. An increase of 4 points in the FACIT-Fatigue score was considered clinically meaningful. Change from Administration 1 was reported for individual administration schedules. TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. | Administration 1 (Baseline), 6 months |
| Change From Baseline in Morning Stiffness as Assessed Using VAS at Month 6 | Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe. | Baseline, 6 months |
| Beer Yaakov |
| 6093000 |
| Israel |
| Beersheba | 8410101 | Israel |
| Hadera | 38100 | Israel |
| Haifa | 31048 | Israel |
| Haifa | 3109601 | Israel |
| Haifa | 34362 | Israel |
| Jerusalem | 9112001 | Israel |
| Jerusalem | 91240 | Israel |
| Kfar Saba | 44281 | Israel |
| Petah Tikva | 4937211 | Israel |
| Petah Tikva | 4941492 | Israel |
| Ramat Gan | 5262000 | Israel |
| Ramat Gan | 52621 | Israel |
| Non-compliance |
|
| Due to participant's health fund |
|
| Scheduled surgery |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
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| Secondary | Percentage of Participants With Systemic Manifestations of RA at Baseline | Systemic manifestations included fibromyalgia, osteoporosis, sjogren's syndrome, anemia, rheumatoid nodules, pulmonary fibrosis, vasculitis, peripheral neuropathy or mononeuropathy, scleritis, episcleritis, hypertension, hyperlipidemia, low high-density lipoproteins, diabetes type 1 and type 2, metabolic syndrome, carotid artery disease, transient ischemic attacks, embolic stroke, atherothrombotic stroke, atrial fibrillation, heart failure New York Heart Association (NYHA) Class l/ll, coronary heart disease(angina pectoris/myocardial), aortic aneurism, peripheral arterial occlusive disease, percutaneous coronary interventions, coronary artery bypass, carotid endarterectomy and peripheral arterial bypass. | FAS population. | Posted | Number | percentage of participants | Baseline |
|
|
|
| Secondary | Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study | DMARDs exposure was evaluated for all participants. "Prior DMARDs treatment" included participants, who were treated with DMARDs 8 weeks and according to physician's discretion before being included in the study. "DMARDs treatment at baseline" included participants who were receiving DMARDs when they were included in the study and continued with this concomitant medication in addition to TCZ. Only those participants who received DMARDs prior to start of study and at Baseline up to 6 months were reported. | FAS population. | Posted | Number | percentage of participants | Prior to study start (8 weeks) and Baseline up to 6 months |
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| Secondary | Percentage of Participants With Reason for DMARD Withdrawal | Objective intolerance was determined by medical observation; subjective intolerance was determined by the participant; lack of efficacy was determined by physician discretion. | FAS population. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 6 months |
|
|
|
| Secondary | Percentage of Participants Who Received Biological RA Treatment Prior to Start of Study | Biological RA treatment exposure was evaluated for all participants. "Prior biological RA treatment" included participants who were treated with biological RA treatment 8 weeks before being included in the study. Percentage of participants who did not receive any biological RA treatment and percentage of participants who received one or more biologic RA treatments were reported. | FAS population. | Posted | Number | percentage of participants | Prior to study start (8 weeks) |
|
|
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| Secondary | Percentage of Participants With Type of Previous Biologic RA Treatments | Previous biologic RA treatment included adalimumab, infliximab, golimumab, etanercept, certolizumab, and other (any other previous biologic RA treatment). Same participants may be counted in more than one previous biologic RA treatment category. | FAS population. | Posted | Number | percentage of participants | Up to 6 months |
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| Secondary | Duration of Previous Biologic RA Treatments | Previous biologic RA treatment included adalimumab, infliximab, golimumab, etanercept, certolizumab, and other (any other previous biologic RA treatment). | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and "n"= participants who were evaluable for each category. | Posted | Mean | Standard Deviation | years | Up to 6 months |
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| Secondary | Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments | Lack of efficacy was determined by physician discretion. Previous biologic RA treatment included adalimumab, infliximab, golimumab, etanercept, certolizumab, and other (any other previous biologic RA treatment). | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and "n"= participants who were evaluable for each category. | Posted | Number | percentage of participants | Up to 6 months |
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| Secondary | Percentage of Participants With Dose Modifications | TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and "n"= participants who were evaluable for each category. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
|
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| Secondary | Percentage of Participants With Reasons for Dose Modification | TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. Only those participants who had dose modifications were reported. | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
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| Secondary | Mean Dose at 6 Months | TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and "n"= participants who were evaluable for each category. | Posted | Mean | Standard Deviation | milligrams per kilogram (mg/kg) | 6 months |
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| Secondary | Mean Number of Dose Modifications at 6 Months | TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | dose modification | 6 months |
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| Secondary | Mean Dosing Interval of Treatment at 6 Months | TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. The mean dosing interval between different TCZ administrations (Adm) by participants within 6 months observational period was presented. | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and "n"= participants who were evaluable for each category. | Posted | Mean | Standard Deviation | days | 6 months |
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| Secondary | Percentage of Participants Who Discontinued From TCZ for Safety Versus Efficacy | The safety variable measured the number of participants who discontinued TCZ due to adverse reactions to TCZ, and the efficacy variable measured the participants who discontinued from TCZ due to lack of efficacy according to criteria of the treating physician. | FAS population. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
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| Secondary | Time to Restoration of Initial Dosing Regimen | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | days | 6 months |
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| Secondary | Percentage of Participants Who Adhered to the Dosing Regimen Recommended by Physician | A participant's adherence was calculated based on the adverse event or laboratory abnormality experienced by the participants who required dose modifications as per local TCZ label or protocol. | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
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| Secondary | Percentage of Participants on TCZ Monotherapy | TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. Only those participants who had TCZ as monotherapy were reported. | FAS population. Here, "n"= participants who were evaluable for each category. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 6 months |
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| Secondary | Change From Baseline in Tender Joint Count (TJC) (68 Joints) at Month 6 | The number of tender joints was recorded on the joint assessment form, with no tenderness = 0, and tenderness = 1, for 68 joints, giving a total possible TJC score of 0 to 68. | FAS population. Here, number of participants analyzed = participants with valid data to calculate TJC at the end of study (6 months). | Posted | Mean | Standard Deviation | Tender Joint Count | Baseline, 6 months |
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| Secondary | Change From Baseline in Swollen Joint Count (SJC) (66 Joints) at Month 6 | The number of swollen joints was recorded on the joint assessment form, with no swelling = 0, and swelling =1, for 66 joints, giving a total possible SJC score of 0 to 66. | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Swollen Joint Count | Baseline, 6 months |
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| Secondary | Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) at Month 6 | DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [mm/hr]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission. | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 6 months |
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|
|
| Secondary | Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6 | Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH (mm), and ESR (mm/hr). DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement. EULAR Good response: DAS28 <=3.2 and a CFB <-1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a CFB < -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB >=-0.6, DAS28 >3.2 to <=5.1 or CFB >=-0.6 and DAS28 >5.1 or CFB >=-0.6. | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
|
|
| Secondary | Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 6 | The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician's global assessment (PhGH) of disease activity, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP) (milligrams per deciliter [mg/dL]). SDAI total score = 0-86. A SDAI score of <=3.3 represented clinical remission, a score of <=11.0 represents low disease activity, a score of <=26.0 represented moderate disease activity and a score of >26.0 represented high (or severe) disease. | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 6 months |
|
|
|
|
| Secondary | Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 6 | The CDAI was a combined index for measuring disease activity in RA and used to evaluate disease activity in the absence of laboratory testing of CRP and ESR. It was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH (assessed on 0-100 mm); VAS (0 = no disease activity and 100 = worst disease activity). CDAI total score = 0-76. A CDAI score of <=2.8 represented clinical remission, a score of <=10.0 represented low disease activity, a score of <=22.0 represented moderate disease activity and a score of >22.0 represented high (or severe) disease. | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 6 months |
|
|
|
|
| Secondary | Percentage of Participants Who Achieved 20% Improvement in ACR (ACR20) Response at Month 6 | ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement. | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | 6 months |
|
|
|
| Secondary | Percentage of Participants Who Achieved 50% Improvement in ACR (ACR50) Response at Month 6 | ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR50 response required at least a 50% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement. | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | 6 months |
|
|
|
| Secondary | Percentage of Participants Who Achieved 70% Improvement in ACR (ACR70) Response at Month 6 | ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR70 response required at least a 70% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement. | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | 6 months |
|
|
|
| Secondary | Change From Baseline in CRP at Month 6 | The test for CRP was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. The serum concentration of CRP was measured in mg/dL. A reduction in the level was considered an improvement. | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mg/dL | Baseline, 6 months |
|
|
|
| Secondary | Change From Baseline in ESR at Month 6 | ESR was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. ESR was measured in mm/hr. A reduction in the level was considered an improvement. | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mm/hr | Baseline, 6 months |
|
|
|
| Secondary | Change From Baseline in PhGH at Month 6 | The PhGH was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equaled 0 mm, and was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equaled 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from baseline indicated improvement. | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mm | Baseline, 6 months |
|
|
|
|
| Secondary | Change From Baseline in PGH of Disease Activity at Month 6 | The PGH of disease activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equaled 0 mm, and was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equaled 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from baseline indicated improvement. | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mm | Baseline, 6 months |
|
|
|
|
| Secondary | Change From Baseline in HAQ-DI at Month 6 | The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant's functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from "no difficulty" to "unable to do", corresponding to scores from 0 to 3. The HAQ-DI scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity. A score of <0.5 represented clinical remission. A participant achieved a clinically meaningful improvement in HAQ-DI if they had a reduction from baseline of >=0.22. | ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 6 months |
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|
| Secondary | Change From Baseline in Participant's Assessment of Fatigue Using VAS at Month 6 | Fatigue was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the level of fatigue that they have experienced, ranging from 0 (no fatigue) to 100 (extreme fatigue). | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mm | Baseline, 6 months |
|
|
|
|
| Secondary | Change From Baseline in Participant's Assessment of RA-Related Pain at Month 6 | Severity of pain was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the severity of pain that they had experienced because of their RA, ranging from 0 (no pain) to 100 (unbearable pain). A decrease of 10 points was considered clinically meaningful. | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mm | Baseline, 6 months |
|
|
|
|
| Secondary | Change From Administration 1 in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Questionnaire at Month 6 | The FACIT Measurement System was a collection of health-related quality of life questionnaires targeted to the management of chronic illness and included questions on Physical Well-Being, Social/Family Well-Being, Emotional Well-Being and Functional Well-Being. The FACIT Fatigue Scale was a 13-item tool that measured an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue was measured on a five-point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score of FACIT ranged from 0 to 160. An increase of 4 points in the FACIT-Fatigue score was considered clinically meaningful. Change from Administration 1 was reported for individual administration schedules. TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and "n"= participants who were evaluable for each category. | Posted | Mean | Standard Deviation | Score on a scale | Administration 1 (Baseline), 6 months |
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| Secondary | Change From Baseline in Morning Stiffness as Assessed Using VAS at Month 6 | Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe. | FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mm | Baseline, 6 months |
|
|
|
|
| Primary | Percentage of Participants on TCZ Treatment at 5-6 Months After Treatment Initiation | FAS population | Posted | Number | 95% Confidence Interval | percentage of participants | 5-6 months |
|
|
|
| 17 |
| 184 |
| 77 |
| 184 |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Upper abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| Post procedural sepsis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Acute renal failure | Renal and urinary disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Lymphocytosis | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| Gingival infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| Tracheobronchitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
|
| Arteriogram coronary | Investigations | MedDRA (17.1) | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
|
| Full blood count decreased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA (17.1) | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Hirsutism | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (17.1) | 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 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.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| Anemia |
|
| Rheumatoid nodules |
|
| Pulmonary fibrosis |
|
| Vasculitis |
|
| Peripheral neuropathy or mononeuropathy |
|
| Scleritis |
|
| Episcleritis |
|
| Hypertension |
|
| Hyperlipidemia |
|
| Low high-density lipoproteins |
|
| Diabetes type 1 and type 2 |
|
| Metabolic syndrome |
|
| Carotid artery disease |
|
| Transient ischemic attacks |
|
| Embolic stroke |
|
| Atherothrombotic stroke |
|
| Atrial fibrillation |
|
| Heart Failure NYHA class l/ll |
|
| Coronary heart disease(angina pectoris/myocardial) |
|
| Aortic aneurism |
|
| Peripheral arterial occlusive disease |
|
| Percutaneous coronary interventions |
|
| Coronary artery bypass |
|
| Carotid Endarterectomy |
|
| Peripheral arterial bypass |
|
| Title | Measurements |
|---|---|
|
| Leflunomide: Prior to study |
|
| Methotrexate: Prior to study |
|
| Sulfasalazine: Prior to study |
|
| Other DMARD: Prior to study |
|
| Azathioprine: Adm 1 to 6 |
|
| Gold Compounds: Adm 1 to 6 |
|
| Hydroxychloroquine: Adm 1 to 6 |
|
| Leflunomide: Adm 1 to 6 |
|
| Methotrexate: Adm 1 to 6 |
|
| Other DMARD: Adm 1 to 6 |
|
| Sulfasalazine: Adm 1 to 6 |
|
|
| Methotrexate: Other |
|
| Hydroxychloroquine: Lack of efficacy |
|
| Hydroxychloroquine: Intolerance,Objective |
|
| Hydroxychloroquine: Intolerance,Subjective |
|
| Hydroxychloroquine: Other |
|
| Sulfasalazine: Lack of efficacy |
|
| Sulfasalazine: Intolerance,Objective |
|
| Sulfasalazine: Intolerance,Subjective |
|
| Sulfasalazine: Other |
|
| Leflunomide: Lack of efficacy |
|
| Leflunomide: Intolerance,Objective |
|
| Leflunomide: Intolerance,Subjective |
|
| Leflunomide: Other |
|
| Gold compounds: Lack of efficacy |
|
| Azathioprine: Lack of efficacy |
|
| Azathioprine: Intolerance, Subjective |
|
| Other: Lack of efficacy |
|
| Other: Intolerance,Objective |
|
| Other: Intolerance,Subjective |
|
| Other: Unspecified |
|
| Title | Measurements |
|---|---|
|
| Received 3 or more biologic RA treatments |
|
| Title | Measurements |
|---|---|
|
| Etanercept |
|
| Certolizumab |
|
| Other |
|
| Title | Measurements |
|---|---|
|
| Etanercept (n=31) |
|
| Certolizumab (n=3) |
|
| Other (n=13) |
|
| Title | Measurements |
|---|---|
|
| Infliximab: Lack of efficacy (n=15) |
|
| Infliximab: Adverse event (n=15) |
|
| Infliximab: Other (n=15) |
|
| Golimumab: Lack of efficacy (n=8) |
|
| Golimumab: Adverse event (n=8) |
|
| Golimumab: Other (n=8) |
|
| Etanercept: Lack of efficacy (n=31) |
|
| Etanercept: Adverse event (n=31) |
|
| Etanercept: Other (n=31) |
|
| Certolizumab: Lack of efficacy (n=3) |
|
| Certolizumab: Adverse event (n=3) |
|
| Certolizumab: Other (n=3) |
|
| Other: Lack of efficacy (n=13) |
|
| Other: Adverse event (n=13) |
|
| Other: Unspecified (n=13) |
|
|
| TCZ Administration 4 (Week 12) (n=166) |
|
| TCZ Administration 5 (Week 16) (n=158) |
|
| TCZ Administration 6 (Week 20) (n=151) |
|
|
| TCZ Administration 4(Week 12):Adverse event/safety |
|
| TCZ Administration 4 (Week 12): Other reason |
|
| TCZ Administration 5(Week 16):Adverse event/safety |
|
| TCZ Administration 6(Week 20):Adverse event/safety |
|
| TCZ Administration 6 (Week 20): Other reason |
|
|
| TCZ Administration 4 (Week 12) (n=166) |
|
| TCZ Administration 5 (Week 16) (n=158) |
|
| TCZ Administration 6 (Week 20) (n=151) |
|
|
| Between TCZ Adm 4 (Week 12) and 5 (Week 16)(n=158) |
|
| Between TCZ Adm 5 (Week 16) and 6 (Week 20)(n=150) |
|
| Title | Measurements |
|---|---|
|
|
| TCZ Administration 4 (Week 12) (n=166) |
|
| TCZ Administration 5 (Week 16) (n=158) |
|
| TCZ Administration 6 (Week 20) (n=151) |
|
| Title | Measurements |
|---|---|
|
|
| Change at Administration 5 (n=31) |
|
| Change at Administration 6 (n=33) |
|