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| ID | Type | Description | Link |
|---|---|---|---|
| UCB-CER-2010-01 |
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| Name | Class |
|---|---|
| ReSearch Pharmaceutical Services, Inc. | INDUSTRY |
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The main objective is to assess Health-Related Quality of Life (HRQoL) according to physical function, as measured by a specific Questionnaire (Health Assessment Questionnaire), in Rheumatoid Arthritis (RA) patients who begin therapy with subcutaneous Anti-Tumour Necrosis Factor alpha (TNFα) Certolizumab Pegol (CZP).
An open-label, prospective, and post-authorization observational study. This non-interventional study is designed to establish the importance of the measurement of HRQoL data and patient-reported outcomes in clinical practice in patients with RA, and to assess efficacy and safety use of CZP according to the summary of product characteristics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Certolizumab Pegol treatment | Patients with RA who begin therapy with Certolizumab Pegol (CZP) will be consecutively included in accordance with the selection criteria. The choice of medical treatment is made independently by the physician before evaluating the possible participation of the patient in the protocol. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 | The HAQ-DI is a measure of function in Rheumatoid Arthritis. There are 20 items in eight categories that represent a comprehensive set of functional activities on a scale from 0 (without difficulty) to 3 (unable to perform without assistance). 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. | From Baseline (Week 0) to Week 12 |
| Number of Adverse Drug Reactions (ADRs) during the study (up to 16 weeks) | An ADR is an Adverse Event for which a causal relationship between the product and the occurrence is suspected. | From Baseline (Week 0) to the end of the Follow-up Period (Week 16) |
| Number of Serious Adverse Drug Reactions (SADRs) during the study (up to 16 weeks) | A SADR is a serious Adverse Event for which a causal relationship between the product and the occurrence is suspected. | From Baseline (Week 0) to the end of the Follow-up Period (Week 16) |
| Number of subjects with at least one Adverse Drug Reaction (ADR) during the study (up to 16 weeks) | An ADR is an Adverse Event for which a causal relationship between the product and the occurrence is suspected. | From Baseline (Week 0) to the end of the Follow-up Period (Week 16) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Short Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS) at Week 12 | The SF-36 measures the Health Related Quality of Life (HRQoL). It is a 36-item survey that measures eight domains of health. Four of these domains belong to physical health and four domains to mental health. Domain scores are generated from the SF-36. In addition, two summary scores can also be derived from the SF-36: The Physical Component Summary (PCS) and the Mental Component Summary (MCS). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with RA who begin therapy with CZP will be consecutively included in accordance with the selection criteria. The choice of medical treatment is made independently by the physician before evaluating the possible participation of the patient in the study protocol.
The study will include approximately 105 patients from 20 to 25 sites in Spain.
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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 |
|---|---|---|---|---|---|---|
| 11 | A Coruña | Spain | ||||
| 15 |
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| From Baseline (Week 0) to Week 12 |
| Change from Baseline in the Short Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS) at Week 12 | The SF-36 measures the Health Related Quality of Life (HRQoL). It is a 36-item survey that measures eight domains of health. Four of these domains belong to physical health and four domains to mental health. Domain scores are generated from the SF-36. In addition, two summary scores can also be derived from the SF-36: The Physical Component Summary (PCS) and the Mental Component Summary (MCS). | From Baseline (Week 0) to Week 12 |
| Change from Baseline in Patient's Assessment of Arthritis Pain- Visual Analog Scale (VAS) at Week 12 | VAS ranges from 0 (no pain) to 100 (worst pain). | From Baseline (Week 0) to Week 12 |
| Change from Baseline in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) at Week 12 | The DAS28 is used for assessing disease activity in RA. The number of swollen and tender joints will be assessed using 28-joint counts (tender 28 and swollen 28). The ESR is measured in mm/h. In addition the Patient's General Health (GH) is obtained and recorded on a Visual Analog Scale (VAS) of 100 mm. Using this data, the DAS28 [ESR] can be calculated. | From Baseline (Week 0) to Week 12 |
| Change from Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 12 | ESR is an inflammatory parameter measured in mm/h. | From Baseline (Week 0) to Week 12 |
| Change from Baseline in the Rheumatoid Factor (RF) at Week 12 | RF is an inflammatory parameter measured in International Units (IU)/ml. | From Baseline (Week 0) to Week 12 |
| Change from Baseline in Serum C-reactive Protein (CRP) level at Week 12 | CRP is an inflammatory parameter measured in mg/l. | From Baseline (Week 0) to Week 12 |
| Change from Baseline in the C3 level at Week 12 | C3 is an inflammatory parameter. This measurement includes only subjects for which C3 data are available in the medical history of the subject. | From Baseline (Week 0) to Week 12 |
| Change from Baseline in the C4 level at Week 12 | C4 is an inflammatory parameter. This measurement includes only subjects for which C4 data are available in the medical history of the subject. | From Baseline (Week 0) to Week 12 |
| Predictive value of Baseline global ultrasound index in relation to DAS28 at Week 12 | From Baseline (Week 0) to Week 12 |
| Predictive value of Week 6 global ultrasound index in relation to DAS28 at Week 12 | From Week 6 to Week 12 |
| Predictive value of Baseline laboratory data ESR in relation to DAS28 at Week 12 | From Baseline (Week 0) to Week 12 |
| Predictive value of Week 6 laboratory data ESR in relation to DAS28 at Week 12 | From Week 6 to Week 12 |
| Predictive value of Baseline laboratory data CRP in relation to DAS28 at Week 12 | From Baseline (Week 0) to Week 12 |
| Predictive value of Week 6 laboratory data CRP in relation to DAS28 at Week 12 | From Week 6 to Week 12 |
| Predictive value of Baseline laboratory data RF in relation to DAS28 at Week 12 | From Baseline (Week 0) to Week 12 |
| Predictive value of Week 6 laboratory data RF in relation to DAS28 at Week 12 | From Week 6 to Week 12 |
| Predictive value of Baseline Reduced models of ultrasound joint count in relation to DAS28 at Week 12 | From Baseline (Week 0) to Week 12 |
| Predictive value of Week 6 Reduced models of ultrasound joint count in relation to DAS28 at Week 12 | From Week 6 to Week 12 |
| Predictive value of Baseline Reduced models of ultrasound index in relation to DAS28 at Week 12 | From Baseline (Week 0) to Week 12 |
| Predictive value of Week 6 Reduced models of ultrasound index in relation to DAS28 at Week 12 | From Week 6 to Week 12 |
| Change from Baseline in global ultrasound index at Week 6 | Ultrasound assessment by global ultrasound index consists of 24-joint detection and grading (from 0 to 3) of gray-scale synovitis and power doppler synovial signal. | From Baseline (Week 0) to Week 6 |
| Change from Baseline in global ultrasound index at Week 12 | Ultrasound assessment by global ultrasound index consists of 24-joint detection and grading (from 0 to 3) of gray-scale synovitis and power doppler synovial signal. | From Baseline (Week 0) to Week 12 |
| Number of injection site reactions during the study (up to 16 weeks) | Injection site reactions include: erythema, itching, haematoma, pain, swelling or bruising. | From Baseline (Week 0) to the end of the Follow-up Period (Week 16) |
| Barcelona |
| Spain |
| 20 | Barcelona | Spain |
| 4 | Barcelona | Spain |
| 7 | Barcelona | Spain |
| 21 | Girona | Spain |
| 9 | Granada | Spain |
| 12 | León | Spain |
| 17 | Lleida | Spain |
| 18 | Lleida | Spain |
| 6 | Salamanca | Spain |
| 10 | Seville | Spain |
| 14 | Tarragona | Spain |
| 16 | Tarragona | Spain |
| 5 | Vigo | Spain |
| 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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