Good EULAR Response In Patients With Early Rheumatoid Arthritis

NCT01558089 | Completed Results

• 1 other identifier: B1801138
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 9

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Primary: Participants With EULAR (Good)

  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 Outcomes (7)

• Change From Baseline in Tender Joint Count at Visit 4 (Month 6)

  Baseline and Visit 4 (Month 6)

• Change From Baseline in Swollen Joint Count at Visit 4 (Month 6)

  Baseline and Visit 4 (Month 6)

• Change From Baseline in Patient's Assessment of General Health (VAS) at Visit 4 (Month 6)

  Baseline and Visit 4 (Month 6)

• Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Visit 4 (Month 6)

  Baseline and Visit 4 (Month 6)

• Change From Baseline in EQ-5D Health Index at Visit 4 (Month 6)

  Baseline and Visit 4 (Month 6)

Study Arms (1)

etanercept + methotrexate

Drug: etanercept; Drug: methotrexate

Interventions

etanercept DRUG

according to SmPC and clinical practice

etanercept + methotrexate

methotrexate DRUG

according to SmPC and clinical practice

etanercept + methotrexate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with rheumatoid arthritis who fulfill the inclusion/exclusion criteria

You may qualify if:

• signed and dated informed consent document
• years of age and older at the time of consent
• Patients with moderate-to-severe active rheumatoid arthritis, who satisfy the 2010 Rheumatoid Arthritis Classification Criteria
• 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,
• Patients with DAS28 ≥ 3.2
• Duration of disease symptoms ≥ 6 weeks and ≤2 years
• Failure to respond to prior DMARDs including MTX monotherapy according to routine clinical practice.

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (9)

G. Gennimatas General Hospital /Rheumatology Clinic

Athens, Attica, 11527, Greece

Location

Ippokrateio General Hospital of Athens / 2nd internal Medicine Clinic of the University of Athens

Athens, Attica, 11527, Greece

Location

University General Hospital of Heraklion

Heraklion, Creete, 71110, Greece

Location

G. Papanikolaoy

Thessaloniki, Exochi, 570 10, Greece

Location

424 Military Hospital

Thessaloniki, Thessalonikis, Greece

Location

Euromedica Kyanous Stavros

Thessaloniki, Thessaloniki, 54636, Greece

Location

Laiko General Peripheral Hospital

Athens, 115 27, Greece

Location

Peripheral University General Hospital of Larissa

Larissa, 41 222, Greece

Location

"Olympion therapeutic center" General Clinic of Patras

Pátrai, 26443, Greece

Location

Related Links

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept; Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

18007181021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2012
• First Posted: March 20, 2012
• Study Start: March 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 11, 2016
• Results First Posted: November 11, 2016

Record last verified: 2016-09

Locations

GR (9)