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

UCB Pharma149 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

149

Conditions

Arthritis,Rheumatoid

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (22)

Cork, Cork, Ireland

Bridgend, Bridgend, United Kingdom

Outcomes

Primary Outcomes

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

Secondary Outcomes

Change From Baseline in Disease Activity Score 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score at 78 Weeks

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.

Data from ClinicalTrials.gov

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