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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01288287

Acronym

RA-PROACTIVE

Enrollment

149

Registered

2011-02-02

Start date

2011-07-31

Completion date

2014-12-31

Last updated

2016-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis,Rheumatoid

Keywords

Certolizumab pegol, Cimzia®

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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	Baseline (Week 0), 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.

Secondary

Measure	Time frame	Description
Change From Baseline in Disease Activity Score 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score at 78 Weeks	Baseline (Week 0), 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.
Percentage of Participants With a Disease Activity Score (DAS)-Based European League Against Rheumatoid Arthritis (EULAR) Response at 78 Weeks Compared to Baseline	Baseline (Week 0), 78 weeks	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.
Change From Baseline in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores at 78 Weeks	Baseline (Week 0), 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.
Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Scores at 78 Weeks	Baseline (Week 0), 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.

Countries

Ireland, United Kingdom

Participant flow

Recruitment details

This observational study started to enroll patients in July 2011 in the United Kingdom and Ireland.

Pre-assignment details

Of the 149 enrolled patients, 147 are included in the Safety Set.

Participants by arm

Arm	Count
Safety Set (All Patients) Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic. Safety Set consists of all patients entered into the study who took at least one dose of Certolizumab Pegol.	147
Total	147

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lack of Efficacy	13
Overall Study	Lost to Follow-up	8
Overall Study	Other Reason	13
Overall Study	Unknown Reason	1
Overall Study	Unknown Status	7
Overall Study	Withdrawal by Subject	4

Baseline characteristics

Characteristic	Safety Set (All Patients)
Age, Continuous	55.6 years STANDARD_DEVIATION 11.85
Age, Customized < 65 years	111 participants
Age, Customized >= 65 years	36 participants
Sex: Female, Male Female	101 Participants
Sex: Female, Male Male	46 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	3 / 147
serious Total, serious adverse events	8 / 147

Outcome results

Primary

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.