Good EULAR Response in Patients With Early Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— EARLY RA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01558089
• Other study ID #: B1801138
• Status: Completed
• Phase: Phase 4
• First received: February 15, 2012
• Last updated: June 18, 2015
• Start date: March 2013
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• etanercept
according to SmPC and clinical practice
• methotrexate
according to SmPC and clinical practice

Locations

Country	Name	City	State
Greece	G. Gennimatas General Hospital /Rheumatology Clinic	Athens	Attica
Greece	Ippokrateio General Hospital of Athens / 2nd internal Medicine Clinic of the University of Athens	Athens	Attica
Greece	Laiko General Peripheral Hospital	Athens
Greece	University General Hospital of Heraklion	Heraklion	Creete
Greece	Peripheral University General Hospital of Larissa	Larissa
Greece	"Olympion therapeutic center" General Clinic of Patras	Patras
Greece	424 Military Hospital	Thessaloniki	Thessalonikis
Greece	A.H.E.P.A. Hospital/1st Internal Medicine Clinic	Thessaloniki
Greece	G. Papanikolaoy	Thessaloniki	Exochi

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients that achieved Good EULAR response based on DAS28 EULAR response criteria		6 months	No
Secondary	Change from baseline in each component of DAS28		baseline, 6 months	No
Secondary	Change from baseline in HAQ-DI		baseline, 6 months	No
Secondary	Change from baseline in EQ-5D		baseline, 6 months	No

External Links

•   To obtain contact information for a study center near you, click here.