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

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: February 15, 2012
Last updated: June 18, 2015
Last verified: June 2015
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 Phase
Rheumatoid Arthritis
Drug: etanercept
Drug: methotrexate
Phase 4

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:
  • Percentage of patients that achieved Good EULAR response based on DAS28 EULAR response criteria [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in each component of DAS28 [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in HAQ-DI [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in EQ-5D [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]

Enrollment: 78
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with rheumatoid arthritis who fulfill the inclusion/exclusion 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 identifier: NCT01558089

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
A.H.E.P.A. Hospital/1st Internal Medicine Clinic
Thessaloniki, Greece, 54 636
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT01558089     History of Changes
Other Study ID Numbers: B1801138 
Study First Received: February 15, 2012
Last Updated: June 18, 2015
Health Authority: Greece: Ethics Committee

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
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
Sensory System Agents
Peripheral Nervous System Agents processed this record on October 25, 2016