Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2005-001350-24 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
An open ended study in which patients who completed the double-blind study CDP870-027 [NCT00152386] are given Certolizumab Pegol (CZP) and assessed for signs and symptoms of Rheumatoid Arthritis (RA).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Certolizumab Pegol | Experimental | All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Certolizumab Pegol | Biological | Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years | An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. First dose of Certolizumab Pegol (CZP) was at Baseline of the preceding double-blind study [NCT00152386] for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo. | From first dose of CZP to the end of the open-label study (approximately 7 years) |
| Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years | A SAE is any untoward medical occurrence that at any dose:
First dose of CZP was at Baseline of the preceding double-blind study [NCT00152386] for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo. | From first dose of CZP to the end of the open-label study (approximately 7 years) |
| Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study | An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms. | From Entry Visit (Week 0) to the end of the study (approximately 6.5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 48 | The assessments are based on a 20 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. |
Not provided
Inclusion Criteria:
Patients must have either failed to achieve American College of Rheumatology 20 % Response Criteria (ACR20) at Weeks 12 and 14 in C87027 [NCT00152386], or must have completed the entire Week 52 assessment of C87027 [NCT00152386] trial.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 152 | Huntsville | Alabama | United States | |||
| 148 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32100960 | Background | Paul S, Marotte H, Kavanaugh A, Goupille P, Kvien TK, de Longueville M, Mulleman D, Sandborn WJ, Vande Casteele N. Exposure-Response Relationship of Certolizumab Pegol and Achievement of Low Disease Activity and Remission in Patients With Rheumatoid Arthritis. Clin Transl Sci. 2020 Jul;13(4):743-751. doi: 10.1111/cts.12760. Epub 2020 Apr 1. | |
| 22596211 |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
Not provided
The study consists of 2 populations: of subjects who failed to achieve predefined criteria in preceding study NCT00152386 who entered C87028 on Week 16 of preceding study and of those who completed Week 52 of preceding study.
Due to findings of fraud at one site, data of the 10 subjects of the site were not analyzed with data from other sites.
Enrollment of subjects started in June 2005. 121 centers in 22 countries enrolled subjects.
Participant Flow refers to the Safety Set consisting of all enrolled subjects who received at least 1 dose of study medication.
Of the 857 enrolled subjects, 846 subjects are included in the Safety Set. There was 1 enrolled subject who was never dosed.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Certolizumab Pegol | All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| From Baseline of the preceding double-blind study to Week 48 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 96 | The assessments are based on a 20 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | From Baseline of the preceding double-blind study to Week 96 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 144 | The assessments are based on a 20 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | From Baseline of the preceding double-blind study to Week 144 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 192 | The assessments are based on a 20 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | From Baseline of the preceding double-blind study to Week 192 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 240 | The assessments are based on a 20 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | From Baseline of the preceding double-blind study to Week 240 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal | The assessments are based on a 20 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) |
| Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 48 | The assessments are based on a 50 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | From Baseline of the preceding double-blind study to Week 48 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 96 | The assessments are based on a 50 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | From Baseline of the preceding double-blind study to Week 96 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 144 | The assessments are based on a 50 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | From Baseline of the preceding double-blind study to Week 144 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 192 | The assessments are based on a 50 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | From Baseline of the preceding double-blind study to Week 192 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 240 | The assessments are based on a 50 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | From Baseline of the preceding double-blind study to Week 240 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal | The assessments are based on a 50 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) |
| Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 48 | The assessments are based on a 70 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | From Baseline of the preceding double-blind study to Week 48 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 96 | The assessments are based on a 70 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | From Baseline of the preceding double-blind study to Week 96 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 144 | The assessments are based on a 70 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | From Baseline of the preceding double-blind study to Week 144 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 192 | The assessments are based on a 70 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | From Baseline of the preceding double-blind study to Week 192 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 240 | The assessments are based on a 70 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | From Baseline of the preceding double-blind study to Week 240 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal | The assessments are based on a 70 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) |
| Change From Baseline of the Preceding Double-Blind Study to Week 96 in Modified Total Sharp Score (mTSS) | The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively, as assessed by x-rays of the hands and feet. The score ranges from 0 to 448 with higher scores representing greater damage. A negative value in mTSS change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement. | From Baseline of the preceding double-blind study to Week 96 of the open-label study |
| Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire - Disability Index (HAQ-DI) Total Score | The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement. | From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) |
| Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness | Morning stiffness is defined as the time in hours elapsed between the time of usual awakening (even if not in the morning) and the time the subject is as limber as he/she will be during a day involving typical activities. A negative value in duration of morning stiffness change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement. | From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) |
| Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR]) | DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline. | From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) |
| Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit | Good EULAR response is defined as Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR]) improvement from Baseline of the preceding double-blind study > 1.2 and DAS28[ESR] value < 3.2. | From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) |
| Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score | The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept PCS score are scored to yield values between 0 (worst) and 100 (best). | From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) |
| Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score | The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept MCS score are scored to yield values between 0 (worst) and 100 (best). | From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) |
| San Diego |
| California |
| United States |
| 153 | Danbury | Connecticut | United States |
| 133 | Ocala | Florida | United States |
| 140 | Orlando | Florida | United States |
| 150 | Orlando | Florida | United States |
| 145 | Sarasota | Florida | United States |
| 136 | Tampa | Florida | United States |
| 157 | Coeur d'Alene | Idaho | United States |
| 155 | Springfield | Illinois | United States |
| 134 | Wheaton | Maryland | United States |
| 151 | St Louis | Missouri | United States |
| 156 | Lincoln | Nebraska | United States |
| 135 | Charlotte | North Carolina | United States |
| 147 | Cleveland | Ohio | United States |
| 158 | Dayton | Ohio | United States |
| 139 | Charleston | South Carolina | United States |
| 137 | Austin | Texas | United States |
| 143 | San Antonio | Texas | United States |
| 12 | Buenos Aires | Argentina |
| 14 | Capital Federal | Argentina |
| 1 | Capital Federal | Argentina |
| 9 | Capital Federal | Argentina |
| 8 | Ciudad Autonoma de Buenos Aire | Argentina |
| 11 | Córdoba | Argentina |
| 2 | Córdoba | Argentina |
| 13 | Quilmes | Argentina |
| 7 | Rosario | Argentina |
| 10 | San Miguel de Tucumán | Argentina |
| 6 | Santa Fe | Argentina |
| 18 | Malvern | Australia |
| 21 | Maroochydore | Australia |
| 23 | Perth | Australia |
| 179 | Antwerp | Belgium |
| 199 | Liège | Belgium |
| 177 | Merksem | Belgium |
| 29 | Pleven | Bulgaria |
| 221 | Sofia | Bulgaria |
| 28 | Sofia | Bulgaria |
| 30 | Sofia | Bulgaria |
| 26 | Stara Zagora | Bulgaria |
| 43 | Newmarket | Ontario | Canada |
| 32 | Toronto | Ontario | Canada |
| 39 | Toronto | Ontario | Canada |
| 35 | Hamilton | Canada |
| 36 | Kitchener | Canada |
| 201 | Pointe-Claire | Canada |
| 31 | Sainte-Foy | Canada |
| 203 | Winnipeg | Canada |
| 190 | Santiago | Chile |
| 49 | Santiago | Chile |
| 44 | Valdivia | Chile |
| 52 | Rijeka | Croatia |
| 56 | Brno | Czechia |
| 57 | Ostrava Trebovice | Czechia |
| 187 | Pilsen | Czechia |
| 55 | Prague | Czechia |
| 60 | Prague | Czechia |
| 61 | Prague | Czechia |
| 58 | Uherské Hradiště | Czechia |
| 62 | Zlín | Czechia |
| 64 | Pärnu | Estonia |
| 65 | Tallinn | Estonia |
| 63 | Tartu | Estonia |
| 68 | Hyvinkää | Finland |
| 160 | Montpellier | France |
| 71 | Budapest | Hungary |
| 73 | Budapest | Hungary |
| 75 | Bupadest | Hungary |
| 191 | Debrecen | Hungary |
| 76 | Miskolc | Hungary |
| 74 | Szolnok | Hungary |
| 79 | Afula | Israel |
| 82 | Ashkelon | Israel |
| 81 | Haifa | Israel |
| 83 | Haifa | Israel |
| 78 | Ramat Gan | Israel |
| 77 | Tel Aviv | Israel |
| 85 | Ẕerifin | Israel |
| 86 | Riga | Latvia |
| 88 | Riga | Latvia |
| 92 | Alytus | Lithuania |
| 89 | Kaunas | Lithuania |
| 91 | Klaipėda | Lithuania |
| 93 | Panevezys | Lithuania |
| 90 | Šiauliai | Lithuania |
| 94 | Vilnius | Lithuania |
| 95 | Mexicalli | Mexico |
| 96 | Monterrey | Mexico |
| 103 | Auckland | New Zealand |
| 101 | Christchurch | New Zealand |
| 100 | South Canterbury | New Zealand |
| 192 | Tauranga | New Zealand |
| 107 | Moscow | Russia |
| 113 | Moscow | Russia |
| 222 | Moscow | Russia |
| 223 | Moscow | Russia |
| 224 | Moscow | Russia |
| 109 | Saint Petersburg | Russia |
| 111 | Saint Petersburg | Russia |
| 112 | Saint Petersburg | Russia |
| 193 | Saint Petersburg | Russia |
| 110 | Yaroslavl | Russia |
| 117 | Belgrade | Serbia |
| 118 | Belgrade | Serbia |
| 114 | Niška Banja | Serbia |
| 115 | Novi Sad | Serbia |
| 119 | Bratislava | Slovakia |
| 121 | Košice | Slovakia |
| 120 | Piešťany | Slovakia |
| 122 | Piešťany | Slovakia |
| 210 | Dnipro | Ukraine |
| 209 | Donetsk | Ukraine |
| 216 | Donetsk | Ukraine |
| 213 | Ivano-Frankivsk | Ukraine |
| 211 | Kiev | Ukraine |
| 212 | Kiev | Ukraine |
| 215 | Kiev | Ukraine |
| 220 | Kiev | Ukraine |
| 208 | Symferopyl | Ukraine |
| 214 | Zaporizhzhya | Ukraine |
| Keystone EC, Combe B, Smolen J, Strand V, Goel N, van Vollenhoven R, Mease P, Landewe R, Fleischmann R, Luijtens K, van der Heijde D. Sustained efficacy of certolizumab pegol added to methotrexate in the treatment of rheumatoid arthritis: 2-year results from the RAPID 1 trial. Rheumatology (Oxford). 2012 Sep;51(9):1628-38. doi: 10.1093/rheumatology/kes082. Epub 2012 May 16. |
| 22589265 | Result | van der Heijde D, Keystone EC, Curtis JR, Landewe RB, Schiff MH, Khanna D, Kvien TK, Ionescu L, Gervitz LM, Davies OR, Luijtens K, Furst DE. Timing and magnitude of initial change in disease activity score 28 predicts the likelihood of achieving low disease activity at 1 year in rheumatoid arthritis patients treated with certolizumab pegol: a post-hoc analysis of the RAPID 1 trial. J Rheumatol. 2012 Jul;39(7):1326-33. doi: 10.3899/jrheum.111171. Epub 2012 May 15. |
| 21484766 | Result | Curtis JR, Chen L, Luijtens K, Navarro-Millan I, Goel N, Gervitz L, Weinblatt M. Dose escalation of certolizumab pegol from 200 mg to 400 mg every other week provides no additional efficacy in rheumatoid arthritis: an analysis of individual patient-level data. Arthritis Rheum. 2011 Aug;63(8):2203-8. doi: 10.1002/art.30387. |
| 29246162 | Derived | Curtis JR, Winthrop K, O'Brien C, Ndlovu MN, de Longueville M, Haraoui B. Use of a baseline risk score to identify the risk of serious infectious events in patients with rheumatoid arthritis during certolizumab pegol treatment. Arthritis Res Ther. 2017 Dec 15;19(1):276. doi: 10.1186/s13075-017-1466-y. |
| 19015207 | Derived | Smolen J, Landewe RB, Mease P, Brzezicki J, Mason D, Luijtens K, van Vollenhoven RF, Kavanaugh A, Schiff M, Burmester GR, Strand V, Vencovsky J, van der Heijde D. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial. Ann Rheum Dis. 2009 Jun;68(6):797-804. doi: 10.1136/ard.2008.101659. Epub 2008 Nov 17. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline Characteristics refer to the Safety Set (SS). SS consists of all enrolled subjects who received at least 1 dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Certolizumab Pegol | All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Weight | Mean | Standard Deviation | kilogram (kg) |
| ||||||||||||||||||||||
| Height | Mean | Standard Deviation | centimeter (cm) |
|
| 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 Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years | An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. First dose of Certolizumab Pegol (CZP) was at Baseline of the preceding double-blind study [NCT00152386] for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo. | Safety Set | Posted | Number | percentage of participants | From first dose of CZP to the end of the open-label study (approximately 7 years) |
|
|
| ||||||||||||||||||||||||||
| Primary | Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years | A SAE is any untoward medical occurrence that at any dose:
First dose of CZP was at Baseline of the preceding double-blind study [NCT00152386] for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo. | Safety Set | Posted | Number | percentage of participants | From first dose of CZP to the end of the open-label study (approximately 7 years) |
| ||||||||||||||||||||||||||||
| Primary | Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study | An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms. | Safety Set | Posted | Number | percentage of participants | From Entry Visit (Week 0) to the end of the study (approximately 6.5 years) |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 48 | The assessments are based on a 20 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | Of the 846 subjects in the Safety Set (SS), 733 are included in this analysis. Data not available for 113 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 48 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 96 | The assessments are based on a 20 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | Of the 846 subjects in the Safety Set (SS), 668 are included in this analysis. Data not available for 178 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 96 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 144 | The assessments are based on a 20 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | Of the 846 subjects in the Safety Set (SS), 602 are included in this analysis. Data not available for 244 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 144 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 192 | The assessments are based on a 20 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | Of the 846 subjects in the Safety Set (SS), 537 are included in this analysis. Data not available for 309 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 192 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 240 | The assessments are based on a 20 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | Of the 846 subjects in the Safety Set (SS), 183 are included in this analysis. Data not available for 663 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 240 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal | The assessments are based on a 20 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | Of the 846 subjects in the Safety Set (SS), 841 are included in this analysis. Data not available for 5 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 48 | The assessments are based on a 50 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | Of the 846 subjects in the Safety Set (SS), 733 are included in this analysis. Data not available for 113 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 48 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 96 | The assessments are based on a 50 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | Of the 846 subjects in the Safety Set (SS), 668 are included in this analysis. Data not available for 178 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 96 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 144 | The assessments are based on a 50 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | Of the 846 subjects in the Safety Set (SS), 602 are included in this analysis. Data not available for 244 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 144 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 192 | The assessments are based on a 50 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | Of the 846 subjects in the Safety Set (SS), 537 are included in this analysis. Data not available for 309 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 192 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 240 | The assessments are based on a 50 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | Of the 846 subjects in the Safety Set (SS), 183 are included in this analysis. Data not available for 663 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 240 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal | The assessments are based on a 50 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | Of the 846 subjects in the Safety Set (SS), 841 are included in this analysis. Data not available for 5 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 48 | The assessments are based on a 70 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | Of the 846 subjects in the Safety Set (SS), 733 are included in this analysis. Data not available for 113 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 48 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 96 | The assessments are based on a 70 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | Of the 846 subjects in the Safety Set (SS), 668 are included in this analysis. Data not available for 178 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 96 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 144 | The assessments are based on a 70 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | Of the 846 subjects in the Safety Set (SS), 602 are included in this analysis. Data not available for 244 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 144 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 192 | The assessments are based on a 70 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | Of the 846 subjects in the Safety Set (SS), 537 are included in this analysis. Data not available for 309 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 192 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 240 | The assessments are based on a 70 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | Of the 846 subjects in the Safety Set (SS), 183 are included in this analysis. Data not available for 663 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 240 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal | The assessments are based on a 70 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study. | Of the 846 subjects in the Safety Set (SS), 841 are included in this analysis. Data not available for 5 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) |
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline of the Preceding Double-Blind Study to Week 96 in Modified Total Sharp Score (mTSS) | The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively, as assessed by x-rays of the hands and feet. The score ranges from 0 to 448 with higher scores representing greater damage. A negative value in mTSS change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement. | Of the 846 subjects in the Safety Set (SS), 661 are included in this analysis. Data not available for 185 subjects. | Posted | Mean | Standard Deviation | units on a scale | From Baseline of the preceding double-blind study to Week 96 of the open-label study |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire - Disability Index (HAQ-DI) Total Score | The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement. | Of the 846 subjects in the Safety Set (SS), 824 are included in this analysis. Data not available for 22 subjects. | Posted | Mean | Standard Deviation | units on a scale | From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) |
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness | Morning stiffness is defined as the time in hours elapsed between the time of usual awakening (even if not in the morning) and the time the subject is as limber as he/she will be during a day involving typical activities. A negative value in duration of morning stiffness change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement. | Of the 846 subjects in the Safety Set (SS), 838 are included in this analysis. Data not available for 8 subjects. | Posted | Mean | Standard Deviation | hours | From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR]) | DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline. | Of the 846 subjects in the Safety Set (SS), 834 are included in this analysis. Data not available for 12 subjects. | Posted | Mean | Standard Deviation | units on a scale | From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit | Good EULAR response is defined as Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR]) improvement from Baseline of the preceding double-blind study > 1.2 and DAS28[ESR] value < 3.2. | Of the 846 subjects in the Safety Set (SS), 834 are included in this analysis. Data not available for 12 subjects. | Posted | Number | percentage of participants | From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score | The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept PCS score are scored to yield values between 0 (worst) and 100 (best). | Of the 846 subjects in the Safety Set (SS), 777 are included in this analysis. Data not available for 69 subjects. | Posted | Mean | Standard Deviation | units on a scale | From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score | The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept MCS score are scored to yield values between 0 (worst) and 100 (best). | Of the 846 subjects in the Safety Set (SS), 777 are included in this analysis. Data not available for 69 subjects. | Posted | Mean | Standard Deviation | units on a scale | From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) |
|
|
Adverse Events (AEs) were collected up to approximately 7 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study.
AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
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 | Certolizumab Pegol | All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study. | 352 | 846 | 682 | 846 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Neutrophilia | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Lymphadenopathy mediastinal | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Aortic valve disease | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Atrioventricular extrasystoles | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Arnold-Chiari malformation | Congenital, familial and genetic disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Macular hole | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Tooth impacted | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Femoral hernia | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Megacolon | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Lip ulceration | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hepatic cyst | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hepatitis alcoholic | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Allergy to arthropod bite | Immune system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Anorectal infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Peritoneal infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Asymptomatic bacteriuria | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Bursitis infective | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Sialoadenitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Dacryocystitis infective | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Salpingitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Geotrichum infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Herpes zoster disseminated | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Histoplasmosis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Abscess soft tissue | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Bronchitis acute | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Bronchitis chronic | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Obstructive chronic bronchitis with acute exacerbation | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pyothorax | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Nocardiosis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Condyloma acuminatum | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Burn infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pyoderma | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Meningitis streptococcal | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Disseminated tuberculosis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Tuberculous pleurisy | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Chronic tonsillitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Laryngopharyngitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Nasal vestibulitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Yersinia bacteraemia | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Haemothorax | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Dislocation of joint prosthesis | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Complication of device removal | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Anastomotic ulcer | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Polytraumatism | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Wound secretion | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Neck injury | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Vertebral injury | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Dislocation of vertebra | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Smear cervix abnormal | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Chest X-ray abnormal | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Finger deformity | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Knee deformity | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Lower limb deformity | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Toe deformity | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Upper limb deformity | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Wrist deformity | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Intervertebral disc protusion | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Joint destruction | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Rheumatoid nodule | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Shoulder deformity | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastric cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Malignant peritoneal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Lip and/ or oral cavity cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Castleman's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Myeloproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Ovarian germ cell teratoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Renal cell carcinoma stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Benign urinary tract neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Vaginal cancer stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cervicobrachial syndrome | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pregnancy on oral contraceptive | Pregnancy, puerperium and perinatal conditions | MedDRA (9.0) | Non-systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Conversion disorder | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Stress incontinence | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Bladder prolapse | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Glomerulonephritis membranoproliferative | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cervical polyp | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Ovarian haemorrhage | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Bartholin's cyst | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Alveolitis fibrosing | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pityriasis rosea | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Joint arthroplasty | Surgical and medical procedures | MedDRA (9.0) | Non-systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA (9.0) | Non-systematic Assessment |
| |
| Synovectomy | Surgical and medical procedures | MedDRA (9.0) | Non-systematic Assessment |
| |
| Brain operation | Surgical and medical procedures | MedDRA (9.0) | Non-systematic Assessment |
| |
| Therapy regimen changed | Surgical and medical procedures | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hysterectomy | Surgical and medical procedures | MedDRA (9.0) | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Post thrombotic syndrome | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Trombophlebitis | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Essential hypertension | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Rheumatoid vasculitis | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Bronchitis acute | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | +1 877 822 9493 (UCB) |
| 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
| ID | Term |
|---|---|
| D000068582 | Certolizumab Pegol |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D007140 | Immunoglobulin Fab Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Estonia |
|
| Slovakia |
|
| Finland |
|
| Ukraine |
|
| Lithuania |
|
| Russian Federation |
|
| Israel |
|
| Chile |
|
| France |
|
| Czech Republic |
|
| Hungary |
|
| Mexico |
|
| Canada |
|
| Argentina |
|
| Belgium |
|
| Croatia |
|
| Australia |
|
| Bulgaria |
|
| Latvia |
|
| New Zealand |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
|