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

Arthritis,Rheumatoid Clinical Trial

— RA-PROACTIVE  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01288287
• Other study ID #: RA0042
• Status: Completed
• Phase: N/A
• First received: January 25, 2011
• Last updated: January 27, 2015
• Start date: July 2011
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeIreland: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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) a 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Arthritis,Rheumatoid

Locations

Country	Name	City	State
Ireland	2	Cork
United Kingdom	14	Abergavenny	Monmouthshire
United Kingdom	22	Ashford	Middlesex
United Kingdom	5	Bath	Somerset
United Kingdom	18	Birmingham	West Midlands
United Kingdom	7	Bridgend
United Kingdom	19	Burton	Staffordshire
United Kingdom	16	Cannock	West Midlands
United Kingdom	25	Cardiff
United Kingdom	3	Chertsey	Surrey
United Kingdom	9	Dudley	West Midlands
United Kingdom	4	Durham	County Durham
United Kingdom	24	Eastbourne	East Sussex
United Kingdom	20	Gillingham	Kent
United Kingdom	10	Liverpool	Merseyside
United Kingdom	11	Manchester	Greater Manchester
United Kingdom	12	Manchester	Greater Manchester
United Kingdom	17	Poole	Dorset
United Kingdom	6	Southampton	Hampshire
United Kingdom	13	Southend	Essex
United Kingdom	15	St. Helens	Lancashire
United Kingdom	1	York	Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Activity Score (DAS) Response at 18 months 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), 18 months	No
Secondary	Change from Baseline in Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score at 18 months		Baseline (Week 0),18 months	No
Secondary	Disease Activity Score (DAS)-based European League Against Rheumatoid Arthritis (EULAR) response at 18 months compared to Baseline	Proportion 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),18 months	No
Secondary	Change from Baseline in Rheumatoid Arthritis Disease Activity Index (RADAI) scores at 18 months	RADAI is a five-item questionnaire administered to patients. The final score range is 0-10, with higher scores denoting a worse disease state.	Baseline (Week 0),18 months	No
Secondary	Change from Baseline in Health Assessment Questionnaire-Disease Index (HAQ -DI) scores at 18 months	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.	Baseline (Week 0),18 months	No