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

NCT02202837

Last updated date
Study Location
CHU Dinant Godinne
Yvoir, Namur, 5530, Belgium
Contact
1-800-718-1021

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]

Call Now

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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Rheumatoid ArthritisCONfident Treatment Decisions in Living With Rheumatoid Arthritis
NCT03317756
  1. Birmingham, Alabama
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Rheumatoid ArthritisEffect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells
NCT03755297
  1. Montpellier,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Rheumatoid ArthritisRheumatoid Arthritis DMARD Intervention and UtilizationStudy
NCT00116727
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical Practice
Official Title 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))
Brief Summary 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
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 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients presenting with moderate-to-severe RA in daily clinical practice
Condition Rheumatoid Arthritis
Intervention Drug: etanercept
etanercept 1 x 50 mg/week or 2 x 25mg/week
Study Groups/Cohorts
  • 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
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 Status Completed
Actual Enrollment
 (submitted: April 23, 2018)
157
Original Estimated Enrollment
 (submitted: July 25, 2014)
140
Actual Study Completion Date April 24, 2017
Actual Primary Completion Date April 24, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT02202837
Other Study ID Numbers B1801378
B1801378 ( Other Identifier: Alias Study Number )
REACH-RA ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2018