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Arthritis,RheumatoidRA-PROACTIVENCT01288287

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

An observational study of Arthritis,Rheumatoid, run by UCB Pharma at 22 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis,Rheumatoid
How many people
149 participants
Where
22 sitesin 2 countries
Study dates
Jul 2011to Dec 2014
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

22 sites in 2 countries.

22 sites in 2 countries

United Kingdom21 sites

  • 14

    Abergavenny, Monmouthshire

  • 22

    Ashford, Middlesex

  • 5

    Bath, Somerset

  • 18

    Birmingham, West Midlands

  • 7

    Bridgend, Bridgend

  • 19

    Burton, Staffordshire

  • 16

    Cannock, West Midlands

  • 25

    Cardiff, Cardiff

  • 3

    Chertsey, Surrey

  • 9

    Dudley, West Midlands

  • 4

    Durham, County Durham

  • 24

    Eastbourne, East Sussex

  • 20

    Gillingham, Kent

  • 10

    Liverpool, Merseyside

  • 11

    Manchester, Greater Manchester

  • 12

    Manchester, Greater Manchester

  • 17

    Poole, Dorset

  • 6

    Southampton, Hampshire

  • 13

    Southend, Essex

  • 15

    St Helens, Lancashire

  • 1

    York, Yorkshire

Other trials in United Kingdom

Ireland1 site

  • 2

    Cork, Cork

Other trials in Ireland

About this study

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.

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.

Read the 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.

Keywords
Certolizumab pegol, Cimzia®
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01288287
Study groupRoleWhat they receive
Week 12 Disease Activity Score (DAS) RespondersPatients 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-RespondersPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (Week 0), 78 weeks

Secondary outcomes (4)

  1. 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.

    Measured: Baseline (Week 0), 78 weeks

  2. 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.

    Measured: Baseline (Week 0), 78 weeks

  3. 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.

    Measured: Baseline (Week 0), 78 weeks

  4. 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.

    Measured: Baseline (Week 0), 78 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionOct 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
149 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01288287
Sponsor's protocol ID
RA0042
Acronym
RA-PROACTIVE
Status last verified
Aug 2016
First submitted
25 Jan 2011
Last updated
16 Sep 2016
Data monitoring committee
No

Publications

  • Kumar N, Naz S, Quinn M, Ryan J, Kumke T, Sheeran T. Treatment of Rheumatoid Arthritis with Certolizumab Pegol: Results from PROACTIVE, a Non-Interventional Study in the UK and Ireland. Adv Ther. 2018 Sep;35(9):1426-1437. doi: 10.1007/s12325-018-0758-1. Epub 2018 Aug 3.

    PubMed 30076523

Questions about this trial

What is this clinical trial studying?

An observational study of Arthritis,Rheumatoid, run by UCB Pharma at 22 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01288287, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2016.

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