An observational study in Arthritis,Rheumatoid, sponsored by UCB Pharma. Completed at 22 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-16.
Sponsored by UCB Pharma (part of UCB S.A.) · Observational
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.
2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.
This study's enrollment of 149 is below the median of 176 across 854 observational studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →UCB Pharma is the lead sponsor of 242 studies on the registry; none are open to participants now.
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Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic
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Exclusion Criteria:
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
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
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.
Time frame: Baseline (Week 0), 78 weeks
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.
Time frame: 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: * DAS28(ESR) ≤ 3.2 and decrease from baseline \> 0.6 and ≤ 1.2, * DAS28(ESR) \> 3.2 and ≤ 5.1 and decrease from baseline \> 0.6, * DAS28(ESR) \> 5.1 and decrease from baseline \> 1.2 Patients without a good or moderate response are considered to be non-responders.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Week 0), 78 weeks
This observational study started to enroll patients in July 2011 in the United Kingdom and Ireland.
| Milestone | All Patients |
|---|---|
| Started | 149 |
| Safety set | 147 |
| Full analysis set | 111 |
| Completed | 103 |
| Not completed | 46 |
| Withdrew: Lost to follow-up | 8 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Lack of efficacy | 13 |
| Withdrew: Other reason | 13 |
| Withdrew: Unknown reason | 1 |
| Withdrew: Unknown status | 7 |
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.
| percentage of patients | Week 12 Disease Activity Score (DAS) Responders | Week 12 Disease Activity Score (DAS) Non-Responders |
|---|---|---|
| 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 | 79.5 (64.7 to 90.2) | 50.0 (23.0 to 77.0) |
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.
| units on a scale | Week 12 Disease Activity Score (DAS) Responders | Week 12 Disease Activity Score (DAS) Non-Responders |
|---|---|---|
| Change From Baseline in Disease Activity Score 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score at 78 Weeks | -2.45 ± 1.454 | -1.63 ± 1.157 |
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: * DAS28(ESR) ≤ 3.2 and decrease from baseline \> 0.6 and ≤ 1.2, * DAS28(ESR) \> 3.2 and ≤ 5.1 and decrease from baseline \> 0.6, * DAS28(ESR) \> 5.1 and decrease from baseline \> 1.2 Patients without a good or moderate response are considered to be non-responders.
| percentage of patients | Week 12 Disease Activity Score (DAS) Responders | Week 12 Disease Activity Score (DAS) Non-Responders |
|---|---|---|
| Good Response | 47.7 | 35.7 |
| Moderate Response | 36.4 | 50.0 |
| No Response | 15.9 | 14.3 |
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.
| units on a scale | Week 12 Disease Activity Score (DAS) Responders | Week 12 Disease Activity Score (DAS) Non-Responders |
|---|---|---|
| Change From Baseline in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores at 78 Weeks | -2.64 ± 2.262 | -1.78 ± 3.048 |
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.
| units on a scale | Week 12 Disease Activity Score (DAS) Responders | Week 12 Disease Activity Score (DAS) Non-Responders |
|---|---|---|
| Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Scores at 78 Weeks | -0.43 ± 0.506 | -0.34 ± 0.606 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Safety Set (All Patients) | — | 8/147 (5.4%) | 3/147 (2%) |
| Event | Safety Set (All Patients) |
|---|---|
| Pulmonary TuberculosisInfections and infestations | 2/147 |
| Abortion inducedSurgical and medical procedures | 2/147 |
| CellulitisInfections and infestations | 1/147 |
| Liver function test abnormalInvestigations | 1/147 |
| Rheumatoid arthritisMusculoskeletal and connective tissue disorders | 1/147 |
| Bladder cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/147 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/147 |
| Event | Safety Set (All Patients) |
|---|---|
| Exposure during pregnancyInjury, poisoning and procedural complications | 2/147 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/147 |
Baseline characteristics refer to the Safety Set, consisting of all patients entered into the study who took at least one dose of Certolizumab Pegol.
| Age, Continuous(years) | Safety Set (All Patients) |
|---|---|
| Mean | 55.6 ± 11.85 |
| Age, Customized(participants) | Safety Set (All Patients) |
|---|---|
| < 65 years | 111 |
| >= 65 years | 36 |
| Sex: Female, Male(Participants) | Safety Set (All Patients) |
|---|---|
| Female | 101 |
| Male | 46 |
The record gives a start of Jul 2011, a primary completion of Oct 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2016, 1 year 8 months after primary completion.
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This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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