Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2005-002629-30 | 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 preceding double-blind study NCT00160602 are given Certolizumab Pegol and assessed for signs and symptoms of Rheumatoid Arthritis.
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: 1 ml of Liquid product 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 6.8 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 CZP was at Baseline of the preceding double-blind study NCT00160602 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 6.8 years) |
| Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 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 NCT00160602 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 6.8 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 6.3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52 | The assessments are based on a 20 % or greater improvement from Baseline to Week 52 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 an American College of Rheumatology 20 % (ACR20) response at Weeks 12 and 14 in C87050 [NCT00160602], or must have completed the entire Week 24 assessment of C87050 [NCT00160602] 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 |
|---|---|---|---|---|---|---|
| 172 | Palm Desert | California | United States | |||
| 185 |
| 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. | |
| 29246162 |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
Not provided
This Open-label Study consists of two different populations:
of those subjects who failed to achieve predefined criteria in preceding study C87050 [NCT00160602] who entered C87051 on Week 16 of the preceding study and of those who completed the Week 24 assessment of the preceding study.
Enrollment started in December 2005. 67 centers in 13 countries enrolled subjects. Participant Flow refers to the Safety Set (SS) consisting of all enrolled subjects who received at least 1 dose of study medication. Due to fraud findings at 1 site, data of the 15 subjects of site were not analyzed with data from all other sites and not part of SS.
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: 1 ml of Liquid product 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 52 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 100 | The assessments are based on a 20 % or greater improvement from Baseline to Week 100 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 100 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 148 | The assessments are based on a 20 % or greater improvement from Baseline to Week 148 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 148 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 196 | The assessments are based on a 20 % or greater improvement from Baseline to Week 196 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 196 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 244 | The assessments are based on a 20 % or greater improvement from Baseline to Week 244 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 244 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 6.8 years) |
| Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52 | The assessments are based on a 50 % or greater improvement from Baseline to Week 52 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 52 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 100 | The assessments are based on a 50 % or greater improvement from Baseline to Week 100 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 100 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 148 | The assessments are based on a 50 % or greater improvement from Baseline to Week 148 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 148 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 196 | The assessments are based on a 50 % or greater improvement from Baseline to Week 196 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 196 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 244 | The assessments are based on a 50 % or greater improvement from Baseline to Week 244 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 244 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 6.8 years) |
| Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52 | The assessments are based on a 70 % or greater improvement from Baseline to Week 52 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 52 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 100 | The assessments are based on a 70 % or greater improvement from Baseline to Week 100 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 100 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 148 | The assessments are based on a 70 % or greater improvement from Baseline to Week 148 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 148 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 196 | The assessments are based on a 70 % or greater improvement from Baseline to Week 196 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 196 of the open-label study |
| Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 244 | The assessments are based on a 70 % or greater improvement from Baseline to Week 244 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 244 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 6.8 years) |
| Change From Baseline of the Preceding Double-Blind Study to Week 104 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 104 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 6.8 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 6.8 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 6.8 years) |
| Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit | Good EULAR response is defined as 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 6.8 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 6.8 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 6.8 years) |
| Pasadena |
| California |
| United States |
| 170 | Santa Maria | California | United States |
| 194 | Whittier | California | United States |
| 176 | Naples | Florida | United States |
| 186 | Palm Harbor | Florida | United States |
| 188 | Kansas City | Missouri | United States |
| 182 | St Louis | Missouri | United States |
| 178 | Stratford | New Jersey | United States |
| 192 | Amarillo | Texas | United States |
| 173 | Austin | Texas | United States |
| 175 | San Antonio | Texas | United States |
| 303 | Pleven | Bulgaria |
| 302 | Sofia | Bulgaria |
| 500 | Rijeka | Croatia |
| 600 | Brno | Czechia |
| 603 | Hlučín | Czechia |
| 605 | Prague | Czechia |
| 606 | Prague | Czechia |
| 604 | Sokolov | Czechia |
| 602 | Uherské Hradiště | Czechia |
| 607 | Zlín | Czechia |
| 700 | Tallinn | Estonia |
| 802 | Afula | Israel |
| 805 | Ashkelon | Israel |
| 807 | Haifa | Israel |
| 804 | Jerusalem | Israel |
| 801 | Ramat Gan | Israel |
| 806 | Ẕerifin | Israel |
| 901 | Daugavpils | Latvia |
| 900 | Riga | Latvia |
| 103 | Alytus | Lithuania |
| 100 | Kaunas | Lithuania |
| 102 | Klaipėda | Lithuania |
| 101 | Šiauliai | Lithuania |
| 124 | Bialystok | Poland |
| 120 | Elblag | Poland |
| 123 | Krakow | Poland |
| 125 | Lublin | Poland |
| 121 | Sopot | Poland |
| 122 | Torun | Poland |
| 150 | Moscow | Russia |
| 151 | Moscow | Russia |
| 156 | Moscow | Russia |
| 159 | Moscow | Russia |
| 152 | Saint Petersburg | Russia |
| 154 | Saint Petersburg | Russia |
| 155 | Saint Petersburg | Russia |
| 158 | Saint Petersburg | Russia |
| 153 | Yaroslavl | Russia |
| 132 | Belgrade | Serbia |
| 133 | Belgrade | Serbia |
| 131 | Niška Banja | Serbia |
| 141 | Košice | Slovakia |
| 143 | Košice | Slovakia |
| 140 | Piešťany | Slovakia |
| 142 | Piešťany | Slovakia |
| 162 | Dnipro | Ukraine |
| 161 | Donetsk | Ukraine |
| 168 | Donetsk | Ukraine |
| 165 | Ivano-Frankivsk | Ukraine |
| 163 | Kiev | Ukraine |
| 164 | Kiev | Ukraine |
| 167 | Kiev | Ukraine |
| 169 | Kiev | Ukraine |
| 160 | Simferopol | Ukraine |
| 166 | Zaporizhzhya | Ukraine |
| 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. |
| 26353833 | Derived | Smolen JS, van Vollenhoven R, Kavanaugh A, Strand V, Vencovsky J, Schiff M, Landewe R, Haraoui B, Arendt C, Mountian I, Carter D, van der Heijde D. Certolizumab pegol plus methotrexate 5-year results from the rheumatoid arthritis prevention of structural damage (RAPID) 2 randomized controlled trial and long-term extension in rheumatoid arthritis patients. Arthritis Res Ther. 2015 Sep 10;17(1):245. doi: 10.1186/s13075-015-0767-2. |
| 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: 1 ml of Liquid product 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 | Standard Deviation | 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 6.8 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 CZP was at Baseline of the preceding double-blind study NCT00160602 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 6.8 years) |
|
|
| ||||||||||||||||||||||||||
| Primary | Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 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 NCT00160602 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 6.8 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 6.3 years) |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52 | The assessments are based on a 20 % or greater improvement from Baseline to Week 52 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 567 subjects in the Safety Set (SS), 493 are included in this analysis. Data not available for 74 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 52 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 100 | The assessments are based on a 20 % or greater improvement from Baseline to Week 100 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 567 subjects in the Safety Set (SS), 442 are included in this analysis. Data not available for 125 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 100 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 148 | The assessments are based on a 20 % or greater improvement from Baseline to Week 148 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 567 subjects in the Safety Set (SS), 410 are included in this analysis. Data not available for 157 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 148 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 196 | The assessments are based on a 20 % or greater improvement from Baseline to Week 196 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 567 subjects in the Safety Set (SS), 367 are included in this analysis. Data not available for 200 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 196 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 244 | The assessments are based on a 20 % or greater improvement from Baseline to Week 244 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 567 subjects in the Safety Set (SS), 72 are included in this analysis. Data not available for 495 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 244 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 567 subjects in the Safety Set (SS), 565 are included in this analysis. Data not available for 2 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 6.8 years) |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52 | The assessments are based on a 50 % or greater improvement from Baseline to Week 52 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 567 subjects in the Safety Set (SS), 493 are included in this analysis. Data not available for 74 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 52 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 100 | The assessments are based on a 50 % or greater improvement from Baseline to Week 100 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 567 subjects in the Safety Set (SS), 442 are included in this analysis. Data not available for 125 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 100 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 148 | The assessments are based on a 50 % or greater improvement from Baseline to Week 148 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 567 subjects in the Safety Set (SS), 410 are included in this analysis. Data not available for 157 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 148 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 196 | The assessments are based on a 50 % or greater improvement from Baseline to Week 196 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 567 subjects in the Safety Set (SS), 367 are included in this analysis. Data not available for 200 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 196 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 244 | The assessments are based on a 50 % or greater improvement from Baseline to Week 244 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 567 subjects in the Safety Set (SS), 72 are included in this analysis. Data not available for 495 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 244 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 567 subjects in the Safety Set (SS), 565 are included in this analysis. Data not available for 2 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 6.8 years) |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52 | The assessments are based on a 70 % or greater improvement from Baseline to Week 52 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 567 subjects in the Safety Set (SS), 493 are included in this analysis. Data not available for 74 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 52 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 100 | The assessments are based on a 70 % or greater improvement from Baseline to Week 100 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 567 subjects in the Safety Set (SS), 442 are included in this analysis. Data not available for 125 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 100 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 148 | The assessments are based on a 70 % or greater improvement from Baseline to Week 148 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 567 subjects in the Safety Set (SS), 410 are included in this analysis. Data not available for 157 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 148 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 196 | The assessments are based on a 70 % or greater improvement from Baseline to Week 196 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 567 subjects in the Safety Set (SS), 367 are included in this analysis. Data not available for 200 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 196 of the open-label study |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 244 | The assessments are based on a 70 % or greater improvement from Baseline to Week 244 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 567 subjects in the Safety Set (SS), 72 are included in this analysis. Data not available for 495 subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline of the preceding double-blind study to Week 244 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 567 subjects in the Safety Set (SS), 565 are included in this analysis. Data not available for 2 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 6.8 years) |
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline of the Preceding Double-Blind Study to Week 104 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 567 subjects in the Safety Set (SS), 423 are included in this analysis. Data not available for 144 subjects. | Posted | Mean | Standard Deviation | units on a scale | From Baseline of the preceding double-blind study to Week 104 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 567 subjects in the Safety Set (SS), 560 are included in this analysis. Data not available for 7 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 6.8 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 567 subjects in the Safety Set (SS), 563 are included in this analysis. Data not available for 4 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 6.8 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 567 subjects in the Safety Set (SS), 556 are included in this analysis. Data not available for 11 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 6.8 years) |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit | Good EULAR response is defined as DAS28[ESR] improvement from Baseline of the preceding double-blind study > 1.2 and DAS28[ESR] value < 3.2. | Of the 567 subjects in the Safety Set (SS), 556 are included in this analysis. Data not available for 11 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 6.8 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 567 subjects in the Safety Set (SS), 527 are included in this analysis. Data not available for 40 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 6.8 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 567 subjects in the Safety Set (SS), 527 are included in this analysis. Data not available for 40 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 6.8 years) |
|
|
Adverse Events (AEs) were collected up to approximately 6.8 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: 1 ml of Liquid product 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. | 200 | 567 | 383 | 567 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system 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 |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Acute myocardial infarction | 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 |
| |
| Bradycardia | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pyloric stenosis | Congenital, familial and genetic disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastroduodenitis | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Periproctitis | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Death and sudden death | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hernia | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cyst | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| 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 |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cryptogenic cirrhosis | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Serum sickness | Immune system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Anal abscess | 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 |
| |
| Arthritis bacterial | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gangrene | 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 |
| |
| Osteomyelitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Borrelia infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Lyme disease | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Colitis pseudomembranous | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Salpingo-oophoritis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Tubo-ovarian abscess | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gallbladder empyema | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Bronchitis acute | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Embolic pneumonia | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pneumonia primary atypical | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Papilloma viral infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Carbuncle | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Diabetic foot infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pneumococcal sepsis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Toxic shock syndrome streptococcal | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Disseminated tuberculosis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Lymph node tuberculosis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Meningitis tuberculous | 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 |
| |
| Tuberculosis of central nervous system | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Tuberculosis of intrathoracic lymph nodes | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pyelocystitis | 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 |
| |
| Pyelonephritis chronic | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Stress fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Ankle fracture | 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 |
| |
| Lower limb 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 |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Postoperative hernia | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Neck injury | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Sternal 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 |
| |
| Ulna 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 |
| |
| Transaminases increased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Chest X-ray abnormal | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Arthritis reactive | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Flat feet | 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 |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Tenosynovitis | 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 |
| |
| Breast cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Squamous cell carcinoma of the cervix | 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 |
| |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Colon cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastrointestinal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hodgkin's disease stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Ganglioneuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Lung neoplasm malignant | 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 |
| |
| Testis cancer | 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 |
| |
| Acoustic neuritis | Nervous system disorders | 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 |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Radicular syndrome | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Glomerulonephritis proliferative | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Menorrhagia | 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 |
| |
| Colpocele | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Uterine prolapse | 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 |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal 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 |
| |
| Rheumatoid lung | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hiccups | 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 |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Leukocytoclastic vasculitis | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Peritoneal adhesions division | Surgical and medical procedures | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MedDRA (9.0) | Non-systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Varicose ulceration | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Bronchitis acute | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | 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 |
| |
| Headache | Nervous system 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 |
|
| Ukraine |
|
| Lithuania |
|
| Israel |
|
| Russian Federation |
|
| Czech Republic |
|
| Poland |
|
| Croatia |
|
| Bulgaria |
|
| Latvia |
|
| 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 |
|
|
|
|
|
|
|