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Defining Remission With Etanercept in AS in Real Life Clinical Practice

Last updated on October 13, 2019

FOR MORE INFORMATION
Study Location
CHU Brugmann - Site Horta
Brussels, Bruxelles-capitale, Région DE, 1020 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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Descriptive Information
Brief TitleDefining Remission With Etanercept in AS in Real Life Clinical Practice
Official TitleDefining 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))
Brief SummaryDetermine which remission criterion at Month 6 predicts remission at Month 12 the best.
Detailed Description

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.

Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationPatients visiting Rheumatologist for which the decision has been taken to prescribe Etanercept as first or second line
ConditionAnkylosing Spondylitis
InterventionDrug: etanercept
etanercept 1 x 50 mg/week or 2 x 25mg/week
Study Groups/Cohorts
  • 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
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: April 23, 2018)
84
Original Estimated Enrollment
 (submitted: July 25, 2014)
140
Actual Study Completion DateApril 26, 2017
Actual Primary Completion DateApril 26, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

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 CountriesBelgium
Removed Location Countries  
 
Administrative Information
NCT NumberNCT02202850
Other Study ID NumbersB1801379
B1801379 ( Other Identifier: Alias Study Number )
REACH-AS ( Other Identifier: Alias Study Number )
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 DateApril 2018

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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