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

August 5, 2016 updated by: UCB Pharma

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.

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

149

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Week 12 Disease Activity Score (DAS) Responders
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
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?

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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
Baseline (Week 0), 78 weeks
Change From Baseline in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores at 78 Weeks
Time Frame: 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.
Baseline (Week 0), 78 weeks
Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Scores at 78 Weeks
Time Frame: 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.
Baseline (Week 0), 78 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 25, 2011

First Submitted That Met QC Criteria

January 31, 2011

First Posted (Estimate)

February 2, 2011

Study Record Updates

Last Update Posted (Estimate)

September 16, 2016

Last Update Submitted That Met QC Criteria

August 5, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA0042

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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