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Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical Practice

Last updated on April 11, 2018

FOR MORE INFORMATION
Study Location
Algemeen Stedelijk Ziekenhuis
Aalst, , B-9300 Belgium
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. Patients with active RA who start treatment with etanercept according to the
prevailing reimbursement criteria and dosing in line with the SmPC.

1. First cohort: Etanercept is the first biological product prescribed.

2. Second cohort: Etanercept is the second biological product prescribed.

2. Capable of understanding and willing to provide signed and dated written, voluntary
informed consent before any protocol-specific procedures are performed.

3. Eighteen (18) years of age or older at time of consent.

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

1. History of or current psychiatric illness that would interfere with the subject's
ability to comply with protocol requirements or to give informed consent.

NCT02202837
Pfizer
Completed
Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical Practice

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Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical Practice
Defining Which Remission Criterion At Month 6 Predicts Remission At Month 12 In A Real Life Clinical Practice, In A Cohort Of Rheumatoid Arthritis Patients Treated With Etanercept (Enbrel (Registered))
Defining Which Remission Criterion at Month 6 Predicts Remission at Month 12 in a Real Life Clinical Practice, in a Cohort of Rheumatoid Arthritis Patients Treated with Etanercept

The analysis of the primary endpoint will be based on a logistic regression defining the dependent variable as the remission at Month 12 and the 5 independent variables as CDAI, SDAI, DAS28, DAS28 and Ultrasound, and EULAR Boolean definition for clinical practice and clinical studies.

This analysis will be conducted in each arm of the study as well as after a pooling of both patient groups.

In this context it seems reasonable to ensure the completion of the study by a total approximate number of 100 patients (approximately 50 patients per arm). In order to ensure 50 completers in each arm, 70 patients will be recruited at baseline, taking into account a drop out rate of 30% over 1 year period.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Adult patients presenting with moderate-to-severe RA in daily clinical practice
Rheumatoid Arthritis
Drug: etanercept
etanercept 1 x 50 mg/week or 2 x 25mg/week
  • Etanercept First
    Adult patients with RA who receive etanercept as first biologic, according to prevailing Belgian reimbursement criteria
    Intervention: Drug: etanercept
  • Etanercept second
    Adult patients who receive etanercept as second biologic, according to prevailing Belgian reimbursement criteria
    Intervention: Drug: etanercept
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
135
April 24, 2017
April 24, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with active RA who start treatment with etanercept according to the prevailing reimbursement criteria and dosing in line with the SmPC.

    1. First cohort: Etanercept is the first biological product prescribed.
    2. Second cohort: Etanercept is the second biological product prescribed.
  2. Capable of understanding and willing to provide signed and dated written, voluntary informed consent before any protocol-specific procedures are performed.
  3. Eighteen (18) years of age or older at time of consent.

Exclusion Criteria:

1. History of or current psychiatric illness that would interfere with the subject's ability to comply with protocol requirements or to give informed consent.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT02202837
B1801378
B1801378 ( Other Identifier: Alias Study Number )
REACH-RA ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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