Clinical trial NCT02202850: Defining Remission With Etanercept in AS 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 Ankylosing Spondylitis Patients Treated With Etanercept (Enbrel (Registered))
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-07-29
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients visiting Rheumatologist for which the decision has been taken to prescribe Etanercept as first or second line

Brief summary: Determine 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.

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.

Primary outcomes:
measure: Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission at Month 6 and Maintained Till Month 12
timeFrame: Month 6 up to Month 12
measure: Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 6 and Maintained Till Month 12
timeFrame: Month 6 up to Month 12
measure: Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 6 and Maintained Till Month 12
timeFrame: Month 6 up to Month 12
measure: Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 6 and Maintained Till Month 12
timeFrame: Month 6 up to Month 12
measure: Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 6 and Maintained Till Month 12
timeFrame: Month 6 up to Month 12
measure: Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 6 and Maintained Till Month 12
timeFrame: Month 6 up to Month 12
measure: Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 6 and Maintained Till Month 12
timeFrame: Month 6 up to Month 12
Secondary outcomes:
measure: Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12
timeFrame: Month 3, 6, 9 and 12
measure: Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12
timeFrame: Month 3, 6, 9 and 12
measure: Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12
timeFrame: Month 3, 6, 9 and 12
measure: Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12
timeFrame: Month 3, 6, 9 and 12
measure: Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12
timeFrame: Month 3, 6, 9 and 12
measure: Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 3, 6, 9 and 12
timeFrame: Month 3, 6, 9 and 12
measure: Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 3, 6, 9 and 12
timeFrame: Month 3, 6, 9 and 12
measure: Change From Baseline in Participant Global Assessment (PGA) Score at Month 6 and 12
timeFrame: Baseline, Month 6 and 12
measure: Change From Baseline in Pain Score of Ankylosing Spondylitis at Month 6 and 12
timeFrame: Baseline, Month 6 and 12
measure: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Month 6 and 12
timeFrame: Baseline, Month 6 and 12
measure: Change From Baseline in Inflammation Score of Ankylosing Spondylitis at Month 6 and 12
timeFrame: Baseline, Month 6 and12
measure: Change From Baseline in C-Reactive Protein (CRP) at Month 6 and 12
timeFrame: Baseline, Month 6 and 12
measure: Change From Baseline in Spinal Mobility Measurement at Month 6 and 12
timeFrame: Baseline, Month 6 and 12
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Month 6 and 12
timeFrame: Baseline, Month 6 and 12
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) at Month 6 and 12
timeFrame: Baseline, Month 6 and 12
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) at Month 6 and 12
timeFrame: Baseline, Month 6 and 12
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann - Site Horta
state: Bruxelles-capitale, Région DE
city: Aalst
country: Belgium
facility: ASZ Aalst
city: Aalst
country: Belgium
facility: Algemeen Stedelijk Ziekenhuis
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Ziekenhuis Aalst
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Ziekenhuis
city: Braine L'alleud
country: Belgium
facility: Private Practice
city: Brussels
country: Belgium
facility: CHIREC
city: Brussel
country: Belgium
facility: CHU St-Pierre
city: Champion
country: Belgium
facility: Private Practice
city: Dendermonde
country: Belgium
facility: AZ Sint Blasius
city: Flemalles Haute
country: Belgium
facility: Private Practice
city: Genk
country: Belgium
facility: Biomedical Research Institute/ Department of Rheumatology
city: Genk
country: Belgium
facility: Private Practice Rheumatology
city: Genk
country: Belgium
facility: ReumaClinic
city: Genk
country: Belgium
facility: Reumatologie Associatie
city: Genk
country: Belgium
facility: Private Practice
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Gilly
country: Belgium
facility: Grand Hopital de Charleroi
city: Grand-Manil
country: Belgium
facility: Private Practice
city: Kortrijk
country: Belgium
facility: AZ Groeninge Campus Sint Maarten
city: Liege
country: Belgium
facility: CHU de Liège
city: Lokeren
country: Belgium
facility: Private Practice of Dr. Geert Ghyselen
city: Mechelen
country: Belgium
facility: Louisastraat 18
city: Montignies-sur-Sambre
country: Belgium
facility: Hôpital Sainte Thérèse/ Department of Rheumatology
city: Oostende
country: Belgium
facility: Rheumatology
city: Schoten
country: Belgium
facility: Office of Maenaut Kristien
city: Sijsele-Damme
country: Belgium
facility: Rheumatology
city: Tielt
country: Belgium
facility: Sint-Andries Ziekenhuis
city: Yvoir
country: Belgium
facility: Cliniques Universitaires UCL de Mont-Godinne
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: