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This multicenter, prospective, observational study will assess the efficacy of MabThera/Rituxan (rituximab) and alternative TNF-inhibitors in patients with rheumatoid arthritis who are non-responders or intolerant to a single previous TNF-inhibitor. Data will be collected from each patient from the time of change in biologic therapy for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab | Eligible participants will receive rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy. | ||
| Alternative TNFi | Eligible participants will receive alternative TNFi treatment as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month 6 | The DAS28-3 (ESR) is a measure of disease activity in rheumatoid arthritis. It is calculated from the number of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, and ESR (millimeters per hour [mm/hr]). Total score ranges from 0 to 9.4, where higher score indicated more disease activity. Decrease in score indicated improvement in disease activity. | Baseline (Day of change in biologic therapy [<=Day 1]) and Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month12 | The DAS28-3 (ESR) is a measure of disease activity in rheumatoid arthritis. It is calculated from the number of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, and ESR (millimeters per hour [mm/hr]). Total score ranges from 0 to 9.4, where higher score indicated more disease activity. Decrease in score indicated improvement in disease activity. |
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Inclusion Criteria:
Exclusion Criteria:
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Rheumatoid arthritis patients who are non-responders or intolerant to a single TNF-inhibitor
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winnipeg | Manitoba | R3A 1M3 | Canada | |||
Of 1239 enrolled participants, 9 had no information on second biologic treatment/reasons for discontinuing prior tumor necrosis factor inhibitor (TNFi), 1111 had one previous TNFi,119 had more than one previous TNFi. Of 1111 participants, 728 were considered for primary effectiveness analysis (405 in Rituximab arm and 323 in Alternative TNFi arm).
This observational study was conducted in 11 countries from 02 June 2009 to 19 March 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab | Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy. |
| FG001 | Alternative TNFi |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline (Day of change in biologic therapy [<=Day 1]) and Month 12 |
| Least Squares Mean Change From Baseline in TJC at Months 6 and 12 | The TJC is the most specific clinical method to quantify abnormalities in participants with rheumatoid arthritis (RA). A total of 28 joints were assessed for tenderness. Decrease in score indicated an improvement in disease activity. | Baseline, Month 6, and Month 12 |
| Least Squares Mean Change From Baseline in SJC at Months 6 and 12 | The SJC is the most specific clinical method to quantify abnormalities in participants with RA. A total of 28 joints were assessed for swelling. Decrease in the score indicated improvement in disease activity. | Baseline, Month 6, and Month 12 |
| Least Squares Mean Change From Baseline in C-reactive Protein at Months 6 and 12 | C-reactive protein (CRP) is an inflammation marker. Normal range is from 0-10 milligram/Liter. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in disease activity. | Baseline, Month 6, and Month 12 |
| Least Squares Mean Change From Baseline in ESR at Months 6 and 12 | The ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells sediment in a period of one hour. Normal range is 0-30 mm/hr. A reduction in the level of ESR is considered as an improvement in disease activity. | Baseline, Month 6, and Month 12 |
| Least Squares Mean Change From Baseline in Physician Global Assessment of Disease at Months 6 and 12 | Physician global assessment of disease was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity and 100 mm = highest possible disease activity. Higher scores indicate worsening of disease. | Baseline, Month 6, and Month 12 |
| Least Squares Mean Change From Baseline in Patient Global Assessment of Disease at Months 6 and 12 | Patient Global Assessment of Disease was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = highest possible disease activity. Higher scores indicate worsening of disease. | Baseline, Month 6, and Month 12 |
| Least Squares Mean Change From Baseline in Participant's VAS Pain Score at Months 6 and 12 | Participants were asked to assess their pain intensity (severity of pain) on a 100-millimeter (mm) VAS with the left edge (0 mm) defined as "no pain" and the right edge (100 mm) defined as "severest pain". Higher scores indicate worsening of disease. | Baseline, Month 6, and Month 12 |
| Least Squares Mean Change From Baseline in Health Assessment Questionnaire-Disability Index at Months 6 and 12 | Health Assessment Questionnaire-Disability Index (HAQ-DI) is participant reported assessment of ability to perform tasks in 8 categories of daily living activities as dress/groom, arise, eat, walk, reach, grip, hygiene, and common activities over past week. Each item was scored on a 4-point scale from 0 to 3, where 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible score range was 0-3, where 0 = least difficulty and 3 = extreme difficulty. | Baseline, Month 6, and Month 12 |
| Least Squares Mean Change From Baseline in Duration of Morning Stiffness at Months 6 and 12 | Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes. Participants with available data at the time of assessment were included in the analysis. | Baseline, Month 6, and Month 12 |
| Percentage of Participants Who Remained on Their Second Biologic Therapy at Months 6 and 12 After Start of Second Biologic Therapy | Percentage of participants who remained on their second biologic therapy at 6 and 12 months after start of second biologic therapy were reported. | Month 6 and Month 12 |
| Reasons for Stopping the Second Biologic Therapy and Subsequent Therapy Choice | Up to 12 months |
| Number of Participants With Any Adverse Events, Any Serious Adverse Event, Adverse Events Leading to Withdrawal, and Death | An Adverse event is defined as any unfavorable and unintended medical occurrence/sign (including an abnormal laboratory finding), symptom or disease in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above. | Up to 12 Months |
| Number of Participants With Reasons for Discontinuation of the First TNFi Therapy | The reasons for discontinuation of first TNFi therapy included inefficacy, intolerance and other reasons. The other reasons included complete remission and participants' non-compliance. | Day 1 (Study entry visit) |
| Number of Participants With Previous TNFi Therapy | The previous TNFi therapy included adalimumab, etanercept, infliximab, and others (certolizumab, and golimumab). Number of participants with previous TNFi therapy history was reported. | Day 1 (Study entry visit) |
| Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy | The previous disease-modifying anti-rheumatic drugs therapy included auranofin, aurothioglucose, aurotioprol, azathioprine, chloroquine, ciclosporin, gold, hydroxychloroquine, infliximab, leflunomide, methotrexate, methotrexate sodium, minocycline, penicillamine, sodium aurothiomalate, sodium aurotiosulfate, sulfasalazine, and tiopronin. Number of participants with previous disease-modifying anti-rheumatic drugs therapy was reported. | Day 1 (Study entry visit) |
| Factors Related to Selection of Second Biologic Therapy Following an Insufficient Response or Intolerance to a Single Previous TNFi | The factors included participant characteristics and the reasons that led to the selection of second biologic therapy following an insufficient response or intolerance to a single previous TNFi. The participant characteristics included participant's option for treatment and option for follow-up. The other reasons included RA disease (rheumatoid factor [RF] and cyclic citrullinated peptide [CCP] status), primary failure, and new treatment characteristics (rapidity of action, route of administration, frequency of administration, low infectious risk, and no lymphoma risk). Participants were included in more than one of these factors. | Baseline |
| Saint John |
| New Brunswick |
| E4L 4L2 |
| Canada |
| Brampton | Ontario | L6T 3J1 | Canada |
| Burlington | Ontario | L7R 1E2 | Canada |
| Hamilton | Ontario | L8N 1Y2 | Canada |
| Kitchener | Ontario | N2M 5N6 | Canada |
| London | Ontario | N6A 4V2 | Canada |
| Mississauga | Ontario | L5M 2V8 | Canada |
| St. Catharines | Ontario | L2N 7E4 | Canada |
| Toronto | Ontario | M5G 1X5 | Canada |
| Toronto | Ontario | M9B 1B1 | Canada |
| Windsor | Ontario | N8X 5A6 | Canada |
| Montreal | Quebec | H1T 2M4 | Canada |
| Montreal | Quebec | H2L 1S6 | Canada |
| Montreal | Quebec | H3T 1Y6 | Canada |
| Rimouski | Quebec | G5L 8W1 | Canada |
| Saskatoon | Saskatchewan | S7K 0H6 | Canada |
| Barranquilla | Colombia |
| Bogotá | Colombia |
| Cali | Colombia |
| Abbeville | 80142 | France |
| Aix-les-Bains | 73106 | France |
| Amiens | 80000 | France |
| Amiens | 80094 | France |
| Argenteuil | 95107 | France |
| Bayonne | 64109 | France |
| Belfort | 90000 | France |
| Besançon | 25030 | France |
| Bonneville | 74136 | France |
| Bordeaux | 33076 | France |
| Bordeaux | 33100 | France |
| Boulogne-Billancourt | 92104 | France |
| Brest | 29609 | France |
| Bruges | 33523 | France |
| Bry-sur-Marne | 94366 | France |
| Caen | 14033 | France |
| Cahors | 46005 | France |
| Cambrai | 59407 | France |
| Cannes | 06401 | France |
| Carcassonne | 11890 | France |
| Carhaix-Plouguer | 29835 | France |
| Chambray-lès-Tours | 37171 | France |
| Clermont-Ferrand | 63000 | France |
| Clermont-Ferrand | 63003 | France |
| Colmar | 68024 | France |
| Corbeil-Essonnes | 91106 | France |
| Draguignan | 83300 | France |
| Échirolles | 38434 | France |
| Évreux | 27023 | France |
| Issy-les-Moulineaux | 92130 | France |
| La Roche-sur-Yon | 85925 | France |
| La Source | 45100 | France |
| Laon | 02001 | France |
| Laval | 53015 | France |
| Le Coudray | 28360 | France |
| Le Kremlin-Bicêtre | 94275 | France |
| Le Mans | 72037 | France |
| Libourne | 33505 | France |
| Liévin | 62801 | France |
| Lille | 59037 | France |
| Limoges | 87000 | France |
| Limoges | 87042 | France |
| Lomme | 59160 | France |
| Lorient | 56322 | France |
| Lyon | 69002 | France |
| Lyon | 69275 | France |
| Lyon | 69448 | France |
| Maisons-Laffitte | 78600 | France |
| Mantes-la-Jolie | 78201 | France |
| Marseille | 13285 | France |
| Marseille | 13385 | France |
| Mennecy | 91540 | France |
| Metz | 57077 | France |
| Montauban | 82013 | France |
| Montauban | 82017 | France |
| Montivilliers | 76290 | France |
| Montpellier | 34295 | France |
| Mulhouse | 68070 | France |
| Nantes | 44093 | France |
| Nevers | 58033 | France |
| Nice | 06202 | France |
| Pachuca | 42070 | France |
| Paris | 75014 | France |
| Paris | 75018 | France |
| Paris | 75020 | France |
| Paris | 75475 | France |
| Paris | 75571 | France |
| Paris | 75651 | France |
| Paris | 75674 | France |
| Paris | 75679 | France |
| Paris | 75877 | France |
| Perpignan | 66046 | France |
| Pierre-Bénite | 69495 | France |
| Reims | 51092 | France |
| Reims | 51100 | France |
| Rennes | 35203 | France |
| Rodez | 12027 | France |
| Roubaix | 59056 | France |
| Saint-Aubin-lès-Elbeuf | 76410 | France |
| Saint-Brieuc | 22027 | France |
| Saint-Priest-en-Jarez | 42277 | France |
| Toulon | 83000 | France |
| Toulouse | 31000 | France |
| Toulouse | 31059 | France |
| Tours | 37000 | France |
| Valence | 26000 | France |
| Valenciennes | 59322 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Vannes | 56017 | France |
| Villeneuve-sur-Lot | 47307 | France |
| Vincennes | 94300 | France |
| Aachen | 52064 | Germany |
| Bremen | 28199 | Germany |
| Cologne | 50679 | Germany |
| Cuxhaven | 27476 | Germany |
| Erlangen | 91054 | Germany |
| Frankenberg | 09669 | Germany |
| Frankfurt | 60596 | Germany |
| Gräfelfing | 82166 | Germany |
| Halle | 06128 | Germany |
| Hanover | 30625 | Germany |
| Münster | 48149 | Germany |
| Neuss | 41460 | Germany |
| Rostock | 18059 | Germany |
| Villingen-Schwenningen | 78054 | Germany |
| Athens | 10676 | Greece |
| Athens | 11527 | Greece |
| Athens | 14527 | Greece |
| Athens | 155 62 | Greece |
| Athens | 16673 | Greece |
| Larissa | 411 10 | Greece |
| Coppito | Abruzzo | 67100 | Italy |
| Bari | Apulia | 70124 | Italy |
| San Cesario di Lecce | Apulia | 73016 | Italy |
| Potenza | Basilicate | 85100 | Italy |
| Naples | Campania | 80131 | Italy |
| Telese Terme | Campania | 82037 | Italy |
| Ferrara | Emilia-Romagna | 44100 | Italy |
| Modena | Emilia-Romagna | 41100 | Italy |
| Udine | Friuli Venezia Giulia | 33100 | Italy |
| Milan | Lombardy | 20157 | Italy |
| Milan | Lombardy | 20162 | Italy |
| Gazzi | Sicily | 98125 | Italy |
| Palermo | Sicily | 90127 | Italy |
| Ancona | The Marches | 60020 | Italy |
| Iesi | The Marches | 60035 | Italy |
| Florence | Tuscany | 50139 | Italy |
| Pisa | Tuscany | 56100 | Italy |
| Prato | Tuscany | 59100 | Italy |
| Siena | Tuscany | 53100 | Italy |
| Padova | Veneto | 35128 | Italy |
| Verona | Veneto | 37134 | Italy |
| Chihuahua City | 31238 | Mexico |
| Mexicali | 21100 | Mexico |
| Mexico City | 10700 | Mexico |
| Mexico City | 11850 | Mexico |
| Mexico City | 14141 | Mexico |
| Poza Rica Chacas | 93260 | Mexico |
| Monaco | 98012 | Monaco |
| Ã…lesund | 6026 | Norway |
| Amadora | 3814-501 | Portugal |
| Guimarães | 4835-044 | Portugal |
| Lisbon | 1069-639 | Portugal |
| Porto | 4050-011 | Portugal |
| Córdoba | Cordoba | 14004 | Spain |
| Granada | Granada | 18003 | Spain |
| Granada | Granada | 18014 | Spain |
| León | Leon | 24071 | Spain |
| Lugo | Lugo | 27004 | Spain |
| Madrid | Madrid | 28034 | Spain |
| Madrid | Madrid | 28222 | Spain |
| Madrid | Madrid | 28905 | Spain |
| El Palmar | Murcia | 30120 | Spain |
| Lorca | Murcia | 30800 | Spain |
| Salamanca | Salamanca | 37007 | Spain |
| Seville | Sevilla | 41009 | Spain |
| Torrevieja | 03186 | Spain |
| Abergavenny | NP7 7EG | United Kingdom |
| Aylesbury | HP21 8AL | United Kingdom |
| Blackburn | BB2 3HH | United Kingdom |
| Cambridge | CB2 2QQ | United Kingdom |
| Cannock | WS11 5XY | United Kingdom |
| Cardiff | CF14 4XW | United Kingdom |
| Cheltenham | GL53 7AN | United Kingdom |
| Chertsey | KT16 0PZ | United Kingdom |
| Cosham | PO6 3LY | United Kingdom |
| Derby | DE1 2QY | United Kingdom |
| Durham | DH15TW | United Kingdom |
| Exeter | EX2 5DW | United Kingdom |
| Glasgow | G12 0XH | United Kingdom |
| Harrogate | HG2 7SX | United Kingdom |
| Inverness | IV2 3UV | United Kingdom |
| Lancaster | LA1 4RP | United Kingdom |
| Leeds | LS7 4SA | United Kingdom |
| Lincoln | LN2 5QY | United Kingdom |
| Liverpool | L9 7AL | United Kingdom |
| London | SE1 9RT | United Kingdom |
| London | SE5 9PJ | United Kingdom |
| London | SW17 0QT | United Kingdom |
| Manchester | M13 9PT | United Kingdom |
| Metropolitan Borough of Wirral | CH49 5PE | United Kingdom |
| Poole | BH15 2JB | United Kingdom |
| Salford | M6 8HD | United Kingdom |
| Solihull | B91 2JL | United Kingdom |
| Southport | PR8 6PN | United Kingdom |
| St Helens | WA9 3DA | United Kingdom |
| Stockport | SK2 7JE | United Kingdom |
| Sunderland | SR4 7TP | United Kingdom |
| Sutton in Ashfield | NG17 4JL | United Kingdom |
| Torquay | TQ2 7AA | United Kingdom |
| Truro | TR1 3LJ | United Kingdom |
| Warrington | WA5 1QG | United Kingdom |
| Wolverhampton | DY1 2HQ | United Kingdom |
| Worthing | BN11 2DH | United Kingdom |
| Wrightington | WN6 9EP | United Kingdom |
Eligible participants received alternative TNFi treatment as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
| Safety Population |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at baseline (day of change in biologic therapy [<=Day 1]), had only one previous biologic therapy, and contributed for 24-week disease activity score 28 (DAS28)-erythrocyte sedimentation rate (ESR) for primary analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab | Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy. |
| BG001 | Alternative TNFi | Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month 6 | The DAS28-3 (ESR) is a measure of disease activity in rheumatoid arthritis. It is calculated from the number of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, and ESR (millimeters per hour [mm/hr]). Total score ranges from 0 to 9.4, where higher score indicated more disease activity. Decrease in score indicated improvement in disease activity. | The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline (Day of change in biologic therapy [<=Day 1]) and Month 6 |
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| Secondary | Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month12 | The DAS28-3 (ESR) is a measure of disease activity in rheumatoid arthritis. It is calculated from the number of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, and ESR (millimeters per hour [mm/hr]). Total score ranges from 0 to 9.4, where higher score indicated more disease activity. Decrease in score indicated improvement in disease activity. | The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline (Day of change in biologic therapy [<=Day 1]) and Month 12 |
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| Secondary | Least Squares Mean Change From Baseline in TJC at Months 6 and 12 | The TJC is the most specific clinical method to quantify abnormalities in participants with rheumatoid arthritis (RA). A total of 28 joints were assessed for tenderness. Decrease in score indicated an improvement in disease activity. | The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as 'n'. | Posted | Least Squares Mean | Standard Error | tender joints | Baseline, Month 6, and Month 12 |
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| Secondary | Least Squares Mean Change From Baseline in SJC at Months 6 and 12 | The SJC is the most specific clinical method to quantify abnormalities in participants with RA. A total of 28 joints were assessed for swelling. Decrease in the score indicated improvement in disease activity. | The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as 'n'. | Posted | Least Squares Mean | Standard Error | swollen joints | Baseline, Month 6, and Month 12 |
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| Secondary | Least Squares Mean Change From Baseline in C-reactive Protein at Months 6 and 12 | C-reactive protein (CRP) is an inflammation marker. Normal range is from 0-10 milligram/Liter. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in disease activity. | The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as 'n'. | Posted | Least Squares Mean | Standard Error | milligram/Liter | Baseline, Month 6, and Month 12 |
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| Secondary | Least Squares Mean Change From Baseline in ESR at Months 6 and 12 | The ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells sediment in a period of one hour. Normal range is 0-30 mm/hr. A reduction in the level of ESR is considered as an improvement in disease activity. | The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as 'n'. | Posted | Least Squares Mean | Standard Error | mm/hr | Baseline, Month 6, and Month 12 |
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| Secondary | Least Squares Mean Change From Baseline in Physician Global Assessment of Disease at Months 6 and 12 | Physician global assessment of disease was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity and 100 mm = highest possible disease activity. Higher scores indicate worsening of disease. | The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as 'n'. | Posted | Least Squares Mean | Standard Error | mm | Baseline, Month 6, and Month 12 |
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| Secondary | Least Squares Mean Change From Baseline in Patient Global Assessment of Disease at Months 6 and 12 | Patient Global Assessment of Disease was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = highest possible disease activity. Higher scores indicate worsening of disease. | The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as 'n'. | Posted | Least Squares Mean | Standard Error | mm | Baseline, Month 6, and Month 12 |
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| Secondary | Least Squares Mean Change From Baseline in Participant's VAS Pain Score at Months 6 and 12 | Participants were asked to assess their pain intensity (severity of pain) on a 100-millimeter (mm) VAS with the left edge (0 mm) defined as "no pain" and the right edge (100 mm) defined as "severest pain". Higher scores indicate worsening of disease. | The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as 'n'. | Posted | Least Squares Mean | Standard Error | mm | Baseline, Month 6, and Month 12 |
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| Secondary | Least Squares Mean Change From Baseline in Health Assessment Questionnaire-Disability Index at Months 6 and 12 | Health Assessment Questionnaire-Disability Index (HAQ-DI) is participant reported assessment of ability to perform tasks in 8 categories of daily living activities as dress/groom, arise, eat, walk, reach, grip, hygiene, and common activities over past week. Each item was scored on a 4-point scale from 0 to 3, where 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible score range was 0-3, where 0 = least difficulty and 3 = extreme difficulty. | The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as 'n'. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline, Month 6, and Month 12 |
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| Secondary | Least Squares Mean Change From Baseline in Duration of Morning Stiffness at Months 6 and 12 | Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes. Participants with available data at the time of assessment were included in the analysis. | The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as 'n'. | Posted | Least Squares Mean | Standard Error | minutes | Baseline, Month 6, and Month 12 |
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| Secondary | Percentage of Participants Who Remained on Their Second Biologic Therapy at Months 6 and 12 After Start of Second Biologic Therapy | Percentage of participants who remained on their second biologic therapy at 6 and 12 months after start of second biologic therapy were reported. | Safety analysis population included all enrolled participants with only one previous TNFi whose second biologic therapy (i.e,Treatment Group) and reason for changing biologic therapy was known. | Posted | Number | Percentage of participants | Month 6 and Month 12 |
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| Secondary | Reasons for Stopping the Second Biologic Therapy and Subsequent Therapy Choice | Safety analysis population included all enrolled participants with only one previous TNFi whose second biologic therapy (ie,Treatment Group) and reason for changing biologic therapy was known. | Posted | Number | Number of participants | Up to 12 months |
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| Secondary | Number of Participants With Any Adverse Events, Any Serious Adverse Event, Adverse Events Leading to Withdrawal, and Death | An Adverse event is defined as any unfavorable and unintended medical occurrence/sign (including an abnormal laboratory finding), symptom or disease in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above. | Safety analysis population included all enrolled participants with only one previous TNFi whose second biologic therapy and reason for changing biologic therapy was known. | Posted | Number | participants | Up to 12 Months |
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| Secondary | Number of Participants With Reasons for Discontinuation of the First TNFi Therapy | The reasons for discontinuation of first TNFi therapy included inefficacy, intolerance and other reasons. The other reasons included complete remission and participants' non-compliance. | The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. | Posted | Number | participants | Day 1 (Study entry visit) |
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| Secondary | Number of Participants With Previous TNFi Therapy | The previous TNFi therapy included adalimumab, etanercept, infliximab, and others (certolizumab, and golimumab). Number of participants with previous TNFi therapy history was reported. | The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points are denoted as 'n'. | Posted | Number | participants | Day 1 (Study entry visit) |
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| Secondary | Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy | The previous disease-modifying anti-rheumatic drugs therapy included auranofin, aurothioglucose, aurotioprol, azathioprine, chloroquine, ciclosporin, gold, hydroxychloroquine, infliximab, leflunomide, methotrexate, methotrexate sodium, minocycline, penicillamine, sodium aurothiomalate, sodium aurotiosulfate, sulfasalazine, and tiopronin. Number of participants with previous disease-modifying anti-rheumatic drugs therapy was reported. | The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points are denoted as 'n'. | Posted | Number | participants | Day 1 (Study entry visit) |
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| Secondary | Factors Related to Selection of Second Biologic Therapy Following an Insufficient Response or Intolerance to a Single Previous TNFi | The factors included participant characteristics and the reasons that led to the selection of second biologic therapy following an insufficient response or intolerance to a single previous TNFi. The participant characteristics included participant's option for treatment and option for follow-up. The other reasons included RA disease (rheumatoid factor [RF] and cyclic citrullinated peptide [CCP] status), primary failure, and new treatment characteristics (rapidity of action, route of administration, frequency of administration, low infectious risk, and no lymphoma risk). Participants were included in more than one of these factors. | Safety analysis population included all enrolled participants with only one previous TNFi whose second biologic therapy and reason for changing biologic therapy was known. | Posted | Number | participants | Baseline |
|
Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rituximab | Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy. | 82 | 604 | 79 | 604 | ||
| EG001 | Alternative TNFi | Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy. | 56 | 507 | 79 | 507 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Genital infection female | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Lower respiratory tract infection viral | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Skin infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypertensive heart disease | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Myopericarditis | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pericarditis constrictive | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Peptic ulcer perforation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Sigmoiditis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Laryngeal cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Device dislocation | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Quadriparesis | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal hernia repair | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
| |
| Hospitalisation | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
| |
| Joint fluid drainage | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
| |
| Urethral meatotomy | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 14.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Leukocytoclastic vasculitis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 61 6878333 | global.trial_information@roche.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 |
Not provided
Not provided
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