| Primary | Crude Incidence Rate of Malignancy | Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by mean follow-up in years). Crude (unadjusted) incidence rate calculated as number of malignancy events divided by Participant-Year, multiplied by 1000. | Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. | Posted | | Number | | events per 1000 participant-years | | Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years | | | | ID | Title | Description |
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| OG000 | Etanercept | Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator's discretion and the doses of these were not controlled in the follow-up. | | OG001 | nbDMARDs | Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Cox proportional hazards model adjusted for age, baseline steroid, smoking history, previous cancer, and body mass index was used for analysis. | Regression, Cox | | 0.084 | | Hazard Ratio (HR) | 0.836 | | | 2-Sided | 95 | 0.683 | 1.025 | | | | No | Superiority or Other | | |
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| Primary | Crude Incidence Rate of Lymphoproliferative Malignancy (LM) | Participant-Year estimated by calculating all of years that participants in a study were followed (number of evaluable participants multiplied by mean follow-up in years). Crude (unadjusted) incidence rate calculated as number of LMs divided by Participant-Year, multiplied by 1000. Lymphoproliferative: medical condition characterized by the dysfunction of the immune system often resulting in excessive production of lymphocytes. LMs included lymphoma, myeloma, and leukemia. Adverse outcome was defined as 'lymphoproliferative malignancy' in the field [lymphopro] labeled by BSRBR. | Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. | Posted | | Number | | events per 1000 participant-years | | Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years | | | | ID | Title | Description |
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| OG000 | Etanercept | Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator's discretion and the doses of these were not controlled in the follow-up. | |
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| Primary | Crude Incidence Rate of Serious Infections | Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of serious infections divided by Participant-Year, multiplied by 1000. Serious infections included those infections which required intravenous antibiotics, hospitalization, or resulted in death. Adverse outcome was defined as 'serious infection' in the field [serinf] labeled by BSRBR. | Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. | Posted | | Number | | events per 1000 participant-years | | Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years | | | | ID | Title | Description |
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| OG000 | Etanercept | Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator's discretion and the doses of these were not controlled in the follow-up. | | OG001 |
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| Primary | Crude Incidence Rate of Other Serious Adverse Events | Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of other serious adverse events divided by Participant-Year, multiplied by 1000. Other serious adverse events were based on classifications assigned by the BSRBR and included cardiac serious adverse events (SAEs), central nervous system SAEs, and nonmalignant hematological SAEs. | Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. | Posted | | Number | | events per 1000 participant-years | | Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years | | | | ID | Title | Description |
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| OG000 | Etanercept | Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator's discretion and the doses of these were not controlled in the follow-up. | | OG001 |
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| Primary | Crude Incidence Rate of All-Cause Mortality | Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of deaths divided by Participant-Year, multiplied by 1000. Death was recorded in the adverse outcomes table and in the consultant follow-up table. Where multiple events described death for the same participant, date of death was taken as per the earliest record. | Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. | Posted | | Number | | events per 1000 participant-years | | Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years | | | | ID | Title | Description |
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| OG000 | Etanercept | Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator's discretion and the doses of these were not controlled in the follow-up. | | OG001 | nbDMARDs |
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| Secondary | Percentage of Participants Who Switched to Other Therapy Following Etanercept Discontinuation | Participants who switched from etanercept to either DMARDs or alternative biologic drug are reported. | Full Analysis set (FAS) population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. Only participants treated with ETN were to be analyzed for this outcome measure. | Posted | | Number | | percentage of participants | | Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years | | | | ID | Title | Description |
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| OG000 | Etanercept | Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator's discretion and the doses of these were not controlled in the follow-up. |
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| Secondary | Time on Etanercept Therapy | Time on etanercept therapy was calculated by Kaplan-Meier survival analysis. | FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. Only participants treated with ETN were to be analyzed for this outcome measure. | Posted | | Median | 95% Confidence Interval | years | | Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years | | | | ID | Title | Description |
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| OG000 | Etanercept | Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator's discretion and the doses of these were not controlled in the follow-up. |
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| Secondary | Disease Activity Score Based on 28-Joints Count (DAS28) at Baseline | DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the serological markers of inflammation (erythrocyte sedimentation rate [ESR, millimeter per hour] or C-reactive protein [CRP, milligram per liter]) and patient's general health assessment (recorded on a Visual Analog Scale [VAS] of 0 millimeter [mm]-100 mm). DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity. | FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | Etanercept | Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator's discretion and the doses of these were not controlled in the follow-up. | | OG001 | nbDMARDs | |
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| Secondary | Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Year 1, 2, 3, 4, and 5 | DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity. | FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively. | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | Baseline, Year 1, 2, 3, 4, 5 | | | | ID | Title | Description |
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| OG000 | Etanercept | Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator's discretion and the doses of these were not controlled in the follow-up. | | OG001 |
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| Secondary | Percentage of Participants With Remission and Low Disease Activity as Assessed by Disease Activity Score Based on 28-Joints Count (DAS28) | DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity. | FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively. | Posted | | Number | | percentage of participants | | Year 1, 2, 3, 4, 5 | | | | ID | Title | Description |
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| OG000 | Etanercept | Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator's discretion and the doses of these were not controlled in the follow-up. | | OG001 |
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| Secondary | Time to Remission | DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity. Time to achieve remission was calculated by Kaplan-Meier survival analysis. | FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. | Posted | | Median | 95% Confidence Interval | years | | Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years | | | | ID | Title | Description |
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| OG000 | Etanercept | Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator's discretion and the doses of these were not controlled in the follow-up. | | OG001 | nbDMARDs | |
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| Secondary | Health Assessment Questionnaire (HAQ) Score at Baseline | HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. | FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | Etanercept | Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator's discretion and the doses of these were not controlled in the follow-up. | | OG001 | nbDMARDs |
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| Secondary | Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Year 1, 2, and 3 | HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. | FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively. | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | Baseline, Year 1, 2, 3 | | | | ID | Title | Description |
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| OG000 | Etanercept | Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator's discretion and the doses of these were not controlled in the follow-up. |
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| Secondary | Percentage of Participants With Remission Based on Health Assessment Questionnaire (HAQ) Score | HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3. Participants who had HAQ total score <=0.5 were considered in remission state. | FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively. | Posted | | Number | | percentage of participants | | Year 1, 2, 3 | | | | ID | Title | Description |
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| OG000 | Etanercept | Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator's discretion and the doses of these were not controlled in the follow-up. |
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| Secondary | Health Assessment Questionnaire (HAQ) Score 6 Months Prior to And 6 Months Post-Switching Etanercept | HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. | FAS population. Here "N" (number of participants analyzed): participants evaluable for this measure, "n": participants evaluable for specified time-points. Only participants treated with ETN were to be analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | 6 months prior to and 6 months post switching etanercept | | | | ID | Title | Description |
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| OG000 | Etanercept | Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator's discretion and the doses of these were not controlled in the follow-up. |
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