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Good EULAR Response In Patients With Early Rheumatoid Arthritis

Last updated on November 7, 2019

FOR MORE INFORMATION
Study Location
G. Gennimatas General Hospital /Rheumatology Clinic
Athens, Attica, 11527 Greece
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT01558089
Pfizer
Completed
Good EULAR Response In Patients With Early Rheumatoid Arthritis

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Descriptive Information
Brief TitleGood EULAR Response In Patients With Early Rheumatoid Arthritis
Official TitleAbility 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
Brief SummaryThis 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 DescriptionAll 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
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study Populationpatients with rheumatoid arthritis who fulfill the inclusion/exclusion criteria
ConditionRheumatoid Arthritis
Intervention
  • Drug: etanercept
    according to SmPC and clinical practice
  • Drug: methotrexate
    according to SmPC and clinical practice
Study Groups/Cohortsetanercept + methotrexate
Interventions:
  • Drug: etanercept
  • Drug: methotrexate
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: September 21, 2016)
76
Original Estimated Enrollment
 (submitted: March 19, 2012)
150
Actual Study Completion DateMay 2015
Actual Primary Completion DateMay 2015   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesGreece
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01558089
Other Study ID NumbersB1801138
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2016

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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