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Defining Remission With Etanercept in AS in Real Life Clinical Practice

Last updated on May 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.
Ankylosing Spondylitis
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 AS who start treatment with Etanercept according to prevailing
reimbursement criteria and dosing in line with 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. 18 years of age or older at time of consent.

4. Evidence of a personally signed and dated informed consent document indicating that
the patient (or a legally acceptable representative) has been informed of all
pertinent aspects of the study.

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.

NCT02202850
Pfizer
Completed
Defining Remission With Etanercept in AS in Real Life Clinical Practice

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Defining Remission With Etanercept in AS 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 Ankylosing Spondylitis Patients Treated With Etanercept (Enbrel (Registered))
Determine which remission criterion at Month 6 predicts remission at Month 12 the best.

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 6 independent variables as ASAS partial remission, ASAS 5/6, ASAS60, ASAS40, BASDAI50 and ASDAS inactive disease status.

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
Probability Sample
Patients visiting Rheumatologist for which the decision has been taken to prescribe Etanercept as first or second line
Ankylosing Spondylitis
Drug: etanercept
etanercept 1 x 50 mg/week or 2 x 25mg/week
  • Etanercept First
    Adults patients with AS receiving Etanercept as first biologic, according to prevailing reimbursement criteria in Belgium
    Intervention: Drug: etanercept
  • Etanercept second
    Adults patients with AS receiving Etanercept as second biologic, according to prevailing reimbursement criteria in Belgium
    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
76
April 20, 2017
April 20, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with AS who start treatment with Etanercept according to prevailing reimbursement criteria and dosing in line with 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. 18 years of age or older at time of consent
  4. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

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
 
 
NCT02202850
B1801379
B1801379 ( Other Identifier: Alias Study Number )
REACH-AS ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 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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