Good EULAR Response In Patients With Early Rheumatoid Arthritis (EARLY RA)

September 21, 2016 updated by: Pfizer

Ability To Achieve A Good Eular Response In Patients With Moderate-to-severe Active Early Rheumatoid Arthritis Who Satisfy The New Acr/Eular Classification Criteria Receiving Etanercept + Mtx In Real World Clinical Practice In Greece

This open-label, prospective, observational study will evaluate the clinical response to etanercept + methotrexate therapy in patients with moderate to severe rheumatoid arthritis, as prescribed by the rheumatologist in a normal clinical setting in Greece

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All subjects enrolled should meet the usual prescribing criteria for Etanercept as per the local product information and should be entered into the study at the investigator's discretion

Study Type

Observational

Enrollment (Actual)

76

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

  • Greece
      • Athens, Greece, 115 27
        • Laiko General Peripheral Hospital
      • Larissa, Greece, 41 222
        • Peripheral University General Hospital of Larissa
      • Patras, Greece, 26443
        • "Olympion therapeutic center" General Clinic of Patras
      • Thessaloniki, Greece, 54636
        • Euromedica Kyanous Stavros
    • Attica
      • Athens, Attica, Greece, 11527
        • G. Gennimatas General Hospital /Rheumatology Clinic
      • Athens, Attica, Greece, 11527
        • Ippokrateio General Hospital of Athens / 2nd internal Medicine Clinic of the University of Athens
    • Creete
      • Heraklion, Creete, Greece, 71110
        • University General Hospital of Heraklion
    • Exochi
      • Thessaloniki, Exochi, Greece, 570 10
        • G. Papanikolaoy
    • Thessalonikis
      • Thessaloniki, Thessalonikis, Greece
        • 424 Military Hospital

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

patients with rheumatoid arthritis who fulfill the inclusion/exclusion criteria

Description

Inclusion Criteria:

  1. signed and dated informed consent document
  2. 18 years of age and older at the time of consent
  3. Patients with moderate-to-severe active rheumatoid arthritis, who satisfy the 2010 Rheumatoid Arthritis Classification Criteria
  4. Patients who have been prescribed for first time to receive treatment with MTX + Etanercept prior to enrollment to this study, following routine clinical practice and according to the approved SmPC,
  5. Patients with DAS28 ≥ 3.2
  6. Duration of disease symptoms ≥ 6 weeks and ≤2 years
  7. Failure to respond to prior DMARDs including MTX monotherapy according to routine clinical practice.

Exclusion Criteria:

  1. Contraindications according to the SmPC
  2. History of or present anti-TNFa or other biologic therapy for the treatment of RA
  3. Known significant concurrent medical disease according to investigator's opinion and the current SmPC

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
Intervention / Treatment
etanercept + methotrexate
Drug: etanercept
according to SmPC and clinical practice
Drug: methotrexate
according to SmPC and clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary: Participants With EULAR (Good)
Time Frame: Visit 4 (Month 6)
Good European League Against Rheumatism (EULAR) response at 6 months based on DAS28 EULAR response criteria defined as Good response = DAS28 change >1.2 with DAS28 ≤3.2; Moderate response = DAS28 change >0.6 with DAS28 >3.2-5.1; Non-response = DAS28 change ≤0.6 and absolute DAS28 >5.1
Visit 4 (Month 6)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Tender Joint Count at Visit 4 (Month 6)
Time Frame: Baseline and Visit 4 (Month 6)
In order to calculate the DAS28 the number of swollen joints and tender joints were assessed using the 28 Joint Count (TJC28 and SJC28). A joint was counted as tender/swollen if the tender/swelling code was 'Present'. Swollen and tender 28 joint counts will be performed at visit 1 (baseline), visit 2, visit 3 and visit 4 or early withdrawal.
Baseline and Visit 4 (Month 6)
Change From Baseline in Swollen Joint Count at Visit 4 (Month 6)
Time Frame: Baseline and Visit 4 (Month 6)
In order to calculate the DAS28 the number of swollen joints and tender joints were assessed using the 28 Joint Count (TJC28 and SJC28). A joint was counted as tender/swollen if the tender/swelling code was 'Present'. Swollen and tender 28 joint counts will be performed at visit 1 (baseline), visit 2, visit 3 and visit 4 or early withdrawal.
Baseline and Visit 4 (Month 6)
Change From Baseline in Patient's Assessment of General Health (VAS) at Visit 4 (Month 6)
Time Frame: Baseline and Visit 4 (Month 6)
The patients used a 100 mm Visual Analogue Scale (VAS) to score their general health during the last week. The scale ranged from 0 (no pain) to 100 mm (severe pain)
Baseline and Visit 4 (Month 6)
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Visit 4 (Month 6)
Time Frame: Baseline and Visit 4 (Month 6)
Baseline and Visit 4 (Month 6)
Change From Baseline in EQ-5D Health Index at Visit 4 (Month 6)
Time Frame: Baseline and Visit 4 (Month 6)
The European Quality of Life-5 Dimensions (EQ-5D) was measured on a 5 item scale. The scores for the 5 items (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) ranged from 1 (no problem) to 3 (extreme problems). For EQ-5D, participants rate questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each of the 5 dimensions is divided into 3 levels of perceived problems: Level 1=no problem; level 2=some problem; level 3=extreme problem. A unique health state is defined by combining 1 level from each dimension. A total of 243 possible health states are defined in this way. Each state is referred to in terms of a 5 digit code. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Baseline and Visit 4 (Month 6)
Change From Baseline in HAQ-DI at Visit 4 (Month 6)
Time Frame: Baseline and Visit 4 (Month 6)
The Health Assessment Questionnaire-Disability Index (HAQ-DI) is composed of 20 items. It is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score ranges from 0-3: 0=least difficulty and 3=extreme difficulty.
Baseline and Visit 4 (Month 6)
Predictor of Good EULAR Response Versus Moderate/No Response at Visit 4 (Month 6) - DAS28 (LOCF)
Time Frame: Baseline and Visit 4 (Month 6)
In a first step a univariate logistic regression model was fit for the following baseline variables: DAS28 (n=48), Physician's Global Assessment of Disease Activity (VAS) (n=47), Patient's Global Assessment of Disease Activity (VAS) (n=47), CRP (n=46), Patient Pain (VAS) (n=47), HAQ-DI (n=47), EQ-5D (n=47). Only those variables that were significant at a 10% level were then included in the second step: a multivariate analysis with stepwise regression (entry level=10%, stay level=5%). The final model presented in the Basic Results table displays those covariates which were significant at the 2-sided 5% level (baseline value for DAS28; n=48). Note that DAS28 is not a categorical variable; therefore no stratified results for this variable are presented.
Baseline and Visit 4 (Month 6)

Collaborators and Investigators

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

Sponsor

Pfizer

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.

Helpful Links

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

March 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

February 15, 2012

First Submitted That Met QC Criteria

March 19, 2012

First Posted (Estimate)

March 20, 2012

Study Record Updates

Last Update Posted (Estimate)

November 11, 2016

Last Update Submitted That Met QC Criteria

September 21, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1801138

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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