Rheumatoid Arthritis
Conditions
Keywords
Certolizumab Pegol, Cimzia
Brief summary
This is an observational, non-interventional, non-comparative, post-authorization safety study to evaluate efficacy and long-term safety of Cimzia in adult patients with RA in need of treatment with a biological product.
Detailed description
The purpose of this study is to assess the clinical efficacy of Cimzia in achieving clinical remission after two years of therapy. The observational nature of the study leaves the therapeutic decision exclusively within the discretion of the treating physician.
Interventions
None listed
Sponsors
UCB Pharma GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients eligible for treatment with Cimzia as defined in EU approved SmPC
Exclusion criteria
* Patient previously treated with Cimzia. Patient with known hypersensitivity to any component of Cimzia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Remission at Visit 9 (Around Week 104) Measured by Achieving a Disease Activity Score 28 (DAS28) of < 2.6 | From Baseline to Visit 9 (around Week 104) | The DAS28 was calculated using the tender and swollen joint counts, c-reactive Protein (CRP), or erythrocyte sedimentation rate (ESR), and the Patient's Global Assessment of Disease Activity (PtGADA). The joint assessment was carried out on 28 joints. For the analysis, DAS28 values were categorized into the following groups: * DAS28 \< 2.6: clinical remission * DAS28 from 2.6 to ≤ 3.2: low disease activity * DAS28 from \> 3.2 to 5.1: moderate disease activity * DAS28 \> 5.1: high disease activity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Visit 9 (Around Week 104) in Patients's Arthritis Pain as Measured by Patient's Assessment of Arthritis Pain (PAAP) Visual Analog Scale (VAS) | From Baseline to Visit 9 (around Week 104) | Patients rated how much pain they were experiencing at the time of the visit caused by their Arthritis using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 100 (most severe pain). A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104). |
| Change From Baseline to Visit 9 (Around Week 104) in Patient's Physical Function as Measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) | From Baseline to Visit 9 (around Week 104) | The HAQ-DI contains 20 items on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). The 20 items are grouped in 8 categories with 2 to 3 items each. The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability. A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104). |
| Change From Baseline to Visit 9 (Around Week 104) in Disease Activity Measured by Clinical Disease Activity Index (CDAI) | From Baseline to Visit 9 (around Week 104) | The CDAI was calculated with the equation: CDAI= Tender Joint Count + Swollen Joint Count + PtGADA/10 + PhGADA/10 where PtGADA (mm) is the Patient's Global Assessment of Disease Activity using a Visual Analog Scale (VAS) ranging from 0 to 100, and PhGADA (mm) is the Physician's Global Assessment of Disease Activity using a VAS ranging from 0 to 100. Thus, the CDAI ranges from 0 to 76, with higher values indicating higher disease activity. If any individual term was missing, then the CDAI was set to missing. A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104). |
Countries
Germany
Participant flow
Recruitment details
This non-interventional study started to enroll participants in Germany in October 2009 and concluded in December 2014. Participant Flow refers to the Enrolled Set.
Pre-assignment details
There were 13 patients with missing termination information. Therefore only safety data were analyzed for these 13 patients. Patients with missing termination information were neither considered as completer nor as non-completer in the Clinical Study Report. These patients are considered as non-completers in the summary below.
Participants by arm
| Arm | Count |
|---|---|
| Cimzia All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC | 1,117 |
| Total | 1,117 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 233 |
| Overall Study | Lack of Efficacy | 332 |
| Overall Study | Lost to Follow-up | 49 |
| Overall Study | Missing termination information | 13 |
| Overall Study | Other Reason | 43 |
| Overall Study | Remission of disease | 11 |
| Overall Study | Withdrawal by Subject | 34 |
Baseline characteristics
| Characteristic | Cimzia |
|---|---|
| Age, Continuous | 55.1 years STANDARD_DEVIATION 12.4 |
| Age, Customized <=18 years | 0 Participants |
| Age, Customized >=65 years | 268 Participants |
| Age, Customized Between 18 and 65 years | 848 Participants |
| Age, Customized Missing | 1 Participants |
| Sex: Female, Male Female | 870 Participants |
| Sex: Female, Male Male | 247 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 111 / 1,111 |
| serious Total, serious adverse events | 212 / 1,111 |
Outcome results
Primary
Clinical Remission at Visit 9 (Around Week 104) Measured by Achieving a Disease Activity Score 28 (DAS28) of < 2.6
The DAS28 was calculated using the tender and swollen joint counts, c-reactive Protein (CRP), or erythrocyte sedimentation rate (ESR), and the Patient's Global Assessment of Disease Activity (PtGADA). The joint assessment was carried out on 28 joints. For the analysis, DAS28 values were categorized into the following groups: * DAS28 \< 2.6: clinical remission * DAS28 from 2.6 to ≤ 3.2: low disease activity * DAS28 from \> 3.2 to 5.1: moderate disease activity * DAS28 \> 5.1: high disease activity
Time frame: From Baseline to Visit 9 (around Week 104)
Population: Full Analysis Set (FAS) using Non-Responder Imputation (NRI). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cimzia | Clinical Remission at Visit 9 (Around Week 104) Measured by Achieving a Disease Activity Score 28 (DAS28) of < 2.6 | 14.1 percentage of participants |
Secondary
Change From Baseline to Visit 9 (Around Week 104) in Disease Activity Measured by Clinical Disease Activity Index (CDAI)
The CDAI was calculated with the equation: CDAI= Tender Joint Count + Swollen Joint Count + PtGADA/10 + PhGADA/10 where PtGADA (mm) is the Patient's Global Assessment of Disease Activity using a Visual Analog Scale (VAS) ranging from 0 to 100, and PhGADA (mm) is the Physician's Global Assessment of Disease Activity using a VAS ranging from 0 to 100. Thus, the CDAI ranges from 0 to 76, with higher values indicating higher disease activity. If any individual term was missing, then the CDAI was set to missing. A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).
Time frame: From Baseline to Visit 9 (around Week 104)
Population: Full Analysis Set (FAS) using Mixed Model with Repeated Measures imputation (MMRM). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cimzia | Change From Baseline to Visit 9 (Around Week 104) in Disease Activity Measured by Clinical Disease Activity Index (CDAI) | -14.57 units on a scale | Standard Deviation 10.24 |
Secondary
Change From Baseline to Visit 9 (Around Week 104) in Patient's Physical Function as Measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI)
The HAQ-DI contains 20 items on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). The 20 items are grouped in 8 categories with 2 to 3 items each. The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability. A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).
Time frame: From Baseline to Visit 9 (around Week 104)
Population: Full Analysis Set (FAS) using Mixed Model with Repeated Measures imputation (MMRM). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cimzia | Change From Baseline to Visit 9 (Around Week 104) in Patient's Physical Function as Measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) | -0.26 units on a scale | Standard Deviation 0.39 |
Secondary
Change From Baseline to Visit 9 (Around Week 104) in Patients's Arthritis Pain as Measured by Patient's Assessment of Arthritis Pain (PAAP) Visual Analog Scale (VAS)
Patients rated how much pain they were experiencing at the time of the visit caused by their Arthritis using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 100 (most severe pain). A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).
Time frame: From Baseline to Visit 9 (around Week 104)
Population: Full Analysis Set (FAS) using Mixed Model with Repeated Measures imputation (MMRM). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cimzia | Change From Baseline to Visit 9 (Around Week 104) in Patients's Arthritis Pain as Measured by Patient's Assessment of Arthritis Pain (PAAP) Visual Analog Scale (VAS) | -16.43 units on a scale | Standard Deviation 20.34 |