Clinical trial NCT01558089: Good EULAR Response In Patients With Early Rheumatoid Arthritis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-03-20
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with rheumatoid arthritis who fulfill the inclusion/exclusion criteria

Brief summary: 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

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 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

Primary outcomes:
measure: Primary: Participants With EULAR (Good)
timeFrame: Visit 4 (Month 6)
Secondary outcomes:
measure: Change From Baseline in Tender Joint Count at Visit 4 (Month 6)
timeFrame: Baseline and Visit 4 (Month 6)
measure: Change From Baseline in Swollen Joint Count at Visit 4 (Month 6)
timeFrame: Baseline and Visit 4 (Month 6)
measure: Change From Baseline in Patient's Assessment of General Health (VAS) at Visit 4 (Month 6)
timeFrame: Baseline and Visit 4 (Month 6)
measure: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Visit 4 (Month 6)
timeFrame: Baseline and Visit 4 (Month 6)
measure: Change From Baseline in EQ-5D Health Index at Visit 4 (Month 6)
timeFrame: Baseline and Visit 4 (Month 6)
measure: Change From Baseline in HAQ-DI at Visit 4 (Month 6)
timeFrame: Baseline and Visit 4 (Month 6)
measure: Predictor of Good EULAR Response Versus Moderate/No Response at Visit 4 (Month 6) - DAS28 (LOCF)
timeFrame: Baseline and Visit 4 (Month 6)
Other outcomes:
Locations:
city: Athens
country: Greece
facility: G. Gennimatas General Hospital /Rheumatology Clinic
state: Attica
city: Athens
country: Greece
facility: Ippokrateio General Hospital of Athens / 2nd internal Medicine Clinic of the University of Athens
state: Attica
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
state: Creete
city: Thessaloniki
country: Greece
facility: G. Papanikolaoy
state: Exochi
city: Thessaloniki
country: Greece
facility: 424 Military Hospital
state: Thessalonikis
city: Athens
country: Greece
facility: Laiko General Peripheral Hospital
city: Larissa
country: Greece
facility: Peripheral University General Hospital of Larissa
city: Patras
country: Greece
facility: "Olympion therapeutic center" General Clinic of Patras
city: Thessaloniki
country: Greece
facility: Euromedica Kyanous Stavros
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: