Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01558089
First received: February 15, 2012
Last updated: September 21, 2016
Last verified: September 2016
  Purpose
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

Condition Intervention
Rheumatoid Arthritis
Drug: etanercept
Drug: methotrexate

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Primary: Participants With EULAR (Good) [ Time Frame: Visit 4 (Month 6) ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Change From Baseline in Tender Joint Count at Visit 4 (Month 6) [ Time Frame: Baseline and Visit 4 (Month 6) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Swollen Joint Count at Visit 4 (Month 6) [ Time Frame: Baseline and Visit 4 (Month 6) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Patient's Assessment of General Health (VAS) at Visit 4 (Month 6) [ Time Frame: Baseline and Visit 4 (Month 6) ] [ Designated as safety issue: No ]
    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)

  • Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Visit 4 (Month 6) [ Time Frame: Baseline and Visit 4 (Month 6) ] [ Designated as safety issue: No ]
  • Change From Baseline in EQ-5D Health Index at Visit 4 (Month 6) [ Time Frame: Baseline and Visit 4 (Month 6) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAQ-DI at Visit 4 (Month 6) [ Time Frame: Baseline and Visit 4 (Month 6) ] [ Designated as safety issue: No ]
    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.

  • Predictor of Good EULAR Response Versus Moderate/No Response at Visit 4 (Month 6) - DAS28 (LOCF) [ Time Frame: Baseline and Visit 4 (Month 6) ] [ Designated as safety issue: No ]
    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.


Enrollment: 76
Study Start Date: March 2013
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
etanercept + methotrexate Drug: etanercept
according to SmPC and clinical practice
Drug: methotrexate
according to SmPC and clinical practice

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
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with rheumatoid arthritis who fulfill the inclusion/exclusion criteria
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558089

Locations
Greece
G. Gennimatas General Hospital /Rheumatology Clinic
Athens, Attica, Greece, 11527
Ippokrateio General Hospital of Athens / 2nd internal Medicine Clinic of the University of Athens
Athens, Attica, Greece, 11527
University General Hospital of Heraklion
Heraklion, Creete, Greece, 71110
G. Papanikolaoy
Thessaloniki, Exochi, Greece, 570 10
424 Military Hospital
Thessaloniki, Thessalonikis, Greece
Laiko General Peripheral Hospital
Athens, Greece, 115 27
Peripheral University General Hospital of Larissa
Larissa, Greece, 41 222
"Olympion therapeutic center" General Clinic of Patras
Patras, Greece, 26443
Euromedica Kyanous Stavros
Thessaloniki, Greece, 54636
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01558089     History of Changes
Other Study ID Numbers: B1801138 
Study First Received: February 15, 2012
Results First Received: May 25, 2016
Last Updated: September 21, 2016
Health Authority: Greece: Ethics Committee

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Etanercept
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on January 17, 2017