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To determine if early clinical response at 12 weeks to Certolizumab Pegol (CZP, Cimzia ®) therapy in adult Rheumatoid Arthritis (RA) patients is a predictor of better long term clinical response at 18 months compared with a lack of clinical response at 12 weeks.
Clinical response will be assessed by the percentage of patients achieving a reduction from Baseline in Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points, which is considered the minimum clinically important difference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Week 12 Disease Activity Score (DAS) Responders | Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12 | ||
| Week 12 Disease Activity Score (DAS) Non-Responders | Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12 |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Disease Activity Score (DAS) Response at 78 Weeks Where DAS Response is Defined as a Reduction From Baseline in DAS 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score of Greater Than 1.2 Points | DAS28(ESR) is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), ESR (mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm). 28 joints are examined using: DAS28(ESR) = 0.56 * √(TJC) + 0.28* √(SJC) + 0.70* ln(ESR) + 0.014* PtGADA, with TJC=0 to 28, SJC=0 to 28, PtGADA=0 to 100 mm, ESR=0 to infinite mm/hour but ESR values of greater 250 mm/h are typically measurement errors. DAS28(ESR) ranges from 0 to around 10 with lower scores indicating less disease activity. | Baseline (Week 0), 78 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Disease Activity Score 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score at 78 Weeks | DAS28(ESR) is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), ESR (mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm). 28 joints are examined using: DAS28(ESR) = 0.56 * √(TJC) + 0.28* √(SJC) + 0.70* ln(ESR) + 0.014* PtGADA, with TJC=0 to 28, SJC=0 to 28, PtGADA=0 to 100 mm, ESR=0 to infinite mm/hour but ESR values of greater 250 mm/h are typically measurement errors. DAS28(ESR) ranges from 0 to around 10 with lower scores indicating less disease activity. |
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Inclusion Criteria:
Exclusion Criteria:
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Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2 | Cork | Cork | Ireland | |||
| 7 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30076523 | Derived | Kumar N, Naz S, Quinn M, Ryan J, Kumke T, Sheeran T. Treatment of Rheumatoid Arthritis with Certolizumab Pegol: Results from PROACTIVE, a Non-Interventional Study in the UK and Ireland. Adv Ther. 2018 Sep;35(9):1426-1437. doi: 10.1007/s12325-018-0758-1. Epub 2018 Aug 3. |
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Of the 149 enrolled patients, 147 are included in the Safety Set.
This observational study started to enroll patients in July 2011 in the United Kingdom and Ireland.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients | Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline (Week 0), 78 weeks |
| Percentage of Participants With a Disease Activity Score (DAS)-Based European League Against Rheumatoid Arthritis (EULAR) Response at 78 Weeks Compared to Baseline | Percentage of patients achieving good, moderate, or no EULAR clinical response, where good response is defined as DAS28(ESR) ≤ 3.2 and decrease from baseline by > 1.2; moderate response is defined as achievement of one of the following:
| Baseline (Week 0), 78 weeks |
| Change From Baseline in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores at 78 Weeks | RADAI is a five-item questionnaire administered to patients. The final score range is 0-10, with higher scores denoting a worse disease state. A negative value in RADAI change from Baseline indicates an improvement from Baseline to 78 weeks. | Baseline (Week 0), 78 weeks |
| Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Scores at 78 Weeks | HAQ-DI is a questionnaire which measures function and health-related quality of life. The final score range is 0-3, with higher scores denoting greater disability. A negative value in HAQ-DI change from Baseline indicates an improvement from Baseline to 78 weeks. | Baseline (Week 0), 78 weeks |
| Bridgend |
| Bridgend |
| United Kingdom |
| 25 | Cardiff | Cardiff | United Kingdom |
| 4 | Durham | County Durham | United Kingdom |
| 17 | Poole | Dorset | United Kingdom |
| 24 | Eastbourne | East Sussex | United Kingdom |
| 13 | Southend | Essex | United Kingdom |
| 11 | Manchester | Greater Manchester | United Kingdom |
| 12 | Manchester | Greater Manchester | United Kingdom |
| 6 | Southampton | Hampshire | United Kingdom |
| 20 | Gillingham | Kent | United Kingdom |
| 15 | St Helens | Lancashire | United Kingdom |
| 10 | Liverpool | Merseyside | United Kingdom |
| 22 | Ashford | Middlesex | United Kingdom |
| 14 | Abergavenny | Monmouthshire | United Kingdom |
| 5 | Bath | Somerset | United Kingdom |
| 19 | Burton | Staffordshire | United Kingdom |
| 3 | Chertsey | Surrey | United Kingdom |
| 18 | Birmingham | West Midlands | United Kingdom |
| 16 | Cannock | West Midlands | United Kingdom |
| 9 | Dudley | West Midlands | United Kingdom |
| 1 | York | Yorkshire | United Kingdom |
| Safety Set |
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| Full Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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Baseline characteristics refer to the Safety Set, consisting of all patients entered into the study who took at least one dose of Certolizumab Pegol.
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| ID | Title | Description |
|---|---|---|
| BG000 | Safety Set (All Patients) | Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic. Safety Set consists of all patients entered into the study who took at least one dose of Certolizumab Pegol. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With a Disease Activity Score (DAS) Response at 78 Weeks Where DAS Response is Defined as a Reduction From Baseline in DAS 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score of Greater Than 1.2 Points | DAS28(ESR) is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), ESR (mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm). 28 joints are examined using: DAS28(ESR) = 0.56 * √(TJC) + 0.28* √(SJC) + 0.70* ln(ESR) + 0.014* PtGADA, with TJC=0 to 28, SJC=0 to 28, PtGADA=0 to 100 mm, ESR=0 to infinite mm/hour but ESR values of greater 250 mm/h are typically measurement errors. DAS28(ESR) ranges from 0 to around 10 with lower scores indicating less disease activity. | Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks). | Posted | Number | 95% Confidence Interval | percentage of patients | Baseline (Week 0), 78 weeks |
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| Secondary | Change From Baseline in Disease Activity Score 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score at 78 Weeks | DAS28(ESR) is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), ESR (mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm). 28 joints are examined using: DAS28(ESR) = 0.56 * √(TJC) + 0.28* √(SJC) + 0.70* ln(ESR) + 0.014* PtGADA, with TJC=0 to 28, SJC=0 to 28, PtGADA=0 to 100 mm, ESR=0 to infinite mm/hour but ESR values of greater 250 mm/h are typically measurement errors. DAS28(ESR) ranges from 0 to around 10 with lower scores indicating less disease activity. | Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks). | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0), 78 weeks |
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| Secondary | Percentage of Participants With a Disease Activity Score (DAS)-Based European League Against Rheumatoid Arthritis (EULAR) Response at 78 Weeks Compared to Baseline | Percentage of patients achieving good, moderate, or no EULAR clinical response, where good response is defined as DAS28(ESR) ≤ 3.2 and decrease from baseline by > 1.2; moderate response is defined as achievement of one of the following:
| Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks). | Posted | Number | percentage of patients | Baseline (Week 0), 78 weeks |
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| Secondary | Change From Baseline in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores at 78 Weeks | RADAI is a five-item questionnaire administered to patients. The final score range is 0-10, with higher scores denoting a worse disease state. A negative value in RADAI change from Baseline indicates an improvement from Baseline to 78 weeks. | Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks). | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0), 78 weeks |
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| Secondary | Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Scores at 78 Weeks | HAQ-DI is a questionnaire which measures function and health-related quality of life. The final score range is 0-3, with higher scores denoting greater disability. A negative value in HAQ-DI change from Baseline indicates an improvement from Baseline to 78 weeks. | Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks). | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0), 78 weeks |
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Treatment emergent adverse drug reactions (TEADRs) were collected up to 88 weeks. TEADRs are events with an onset date from the first dose of Certolizumab Pegol (CZP) to 10 weeks after the last dose of CZP.
Adverse Drug Reactions presented below refer to the Safety Set, consisting of all patients entered into the study who took at least one dose of Certolizumab Pegol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safety Set (All Patients) | Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic. Safety Set consists of all patients entered into the study who took at least one dose of Certolizumab Pegol. | 8 | 147 | 3 | 147 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Pulmonary Tuberculosis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Abortion induced | Surgical and medical procedures | MedDRA 14.0 | Non-systematic Assessment |
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| Liver function test abnormal | Investigations | MedDRA 14.0 | Non-systematic Assessment |
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| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| 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 |
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