Long Term Effects of an Early Response to Certolizumab Pegol (CZP, Cimzia®) in Rheumatoid Arthritis (RA) Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Multicentre, Non-interventional, Observational, Cohort Study to Evaluate the Long Term Clinical, Patient Reported and Health Care Resource Utilization Effects of an Early Response to Certolizumab Pegol (Cimzia®) in Rheumatoid Arthritis Patients in Daily Clinical Practice in the United Kingdom and Eire.

Conditions
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Arthritis,Rheumatoid

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent is signed and dated The patient is considered capable of and prepared to adhere to the study protocol procedures The patient is prescribed CZP according to the Summary of Product Characteristics (SmPC) (UK and Eire) and National Institute of Clinical Excellence (NICE) (UK only) guidelines for anti tumor necrosis factor (TNF) α therapy for Rheumatoid Arthritis (RA). The patient is screen-negative for tuberculosis The patient is 18 years of age or above Exclusion Criteria: The patient has been exposed previously to biological disease modifying anti rheumatic drugs (DMARD) agents. Patient has previously participated in this study or the patient has previously been assigned to treatment in a study of CZP or another biological agent used to treat RA. Patient has participated in another study within the last 30 days Patient has any medical or psychiatric condition that, in the opinion of the physician, can jeopardize or would compromise the patient's ability to adequately participate in the study Patient has inadequate literacy to understand and complete the questionnaires. Contraindications stated in the SmPC Patient is pregnant or breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Week 12 Disease Activity Score (DAS) Responders<br>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<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Certolizumab pegol, Cimzia®