Clinical trial NCT02202837: 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))
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-07-29
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients presenting with moderate-to-severe RA in daily clinical practice

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.

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.

Primary outcomes:
measure: Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) Less Than (<) 2.6 at Month 6 and Maintained Till Month 12
timeFrame: Month 6 up to Month 12
measure: Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 at Month 6 and Maintained Till Month 12
timeFrame: Month 6 up to Month 12
measure: Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 at Month 6 and Maintained Till Month 12
timeFrame: Month 6 up to Month 12
measure: Percentage of Participants With Remission at Month 6 and Maintained Till Month 12 Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion
timeFrame: Month 6 up to Month 12
measure: Percentage of Participants With Remission at Month 6 and Maintained Till Month 12 Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion
timeFrame: Month 6 up to Month 12
measure: Percentage of Participants With Remission Based on Seven-Joint Ultrasound (US7) Measurements at Month 6 and Maintained Till Month 12
timeFrame: Month 6 up to Month 12
measure: Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) in Combination With Seven-Joint Ultrasound (US7) Measurement at Month 6 and Maintained Till Month 12
timeFrame: Month 6 up to Month 12
Secondary outcomes:
measure: Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) <2.6 at Month 3, 6, 9 and 12
timeFrame: Month 3, 6, 9 and 12
measure: Percentage of Participants With Simplified Disease Activity Index (SDAI) <=3.3 at Month 3, 6, 9 and 12
timeFrame: Month 3, 6, 9 and 12
measure: Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 at Month 3, 6, 9 and 12
timeFrame: Month 3, 6, 9 and 12
measure: Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion at Month 3, 6, 9 and 12
timeFrame: Month 3, 6, 9 and 12
measure: Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion at Month 3, 6, 9 and 12
timeFrame: Month 3, 6, 9 and 12
measure: Percentage of Participants With no Signs of Ultrasound Synovitis (Ultrasound Remission) at Month 6 and 12
timeFrame: Month 6 and 12
measure: Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) in Combination With Seven-Joint Ultrasound (US7) Measurement at Month 6 and Month 12
timeFrame: Month 6 and 12
measure: Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Month 6 and 12
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Simplified Disease Activity Index (SDAI) at Month 6 and 12
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) at Month 6 and 12
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12
timeFrame: Baseline, Month 6 and Month 12
measure: Change From Baseline in Seven-Joint Ultrasound (US7) Erosion Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12
timeFrame: Month 6 and Month 12
Other outcomes:
Locations:
city: Yvoir
country: Belgium
facility: CHU Dinant Godinne
state: Namur
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: Assebroeck
country: Belgium
facility: St. Lucas ZH
city: Assebroek
country: Belgium
facility: St-Lucas Ziekenhuis
city: Brussels
country: Belgium
facility: Centre Hospitalier Universitarie Brugmann
city: Brussels
country: Belgium
facility: CHIREC
city: Champion
country: Belgium
facility: Private Practice
city: Dendermonde
country: Belgium
facility: AZ Sint Blasius
city: Eeklo
country: Belgium
facility: AZ Alma
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: GHdC
city: Grand-Manil
country: Belgium
facility: Private Practice
city: Kortrijk
country: Belgium
facility: AZ Groeninge Campus Sint Maarten
city: La Louviere
country: Belgium
facility: CHU Tivoli
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire Sart Tilman, Department of Rheumatology
city: Liege
country: Belgium
facility: CHU
city: Liège
country: Belgium
facility: CHU Sart Tilman/ Department of Rheumatology
city: Mechelen
country: Belgium
facility: Louisastraat 18
city: Mons
country: Belgium
facility: CHU Ambroise Pare
city: Montigny Sur Sambre
country: Belgium
facility: Hôpital Saintethérèse
city: Montigny-le-tilleul
country: Belgium
facility: ISPPC de Charleroi
city: Oostende
country: Belgium
facility: AZ Damiaan
city: Schoten
country: Belgium
facility: Office of Maenaut Kristien
city: Tielt
country: Belgium
facility: Sint-Andries Ziekenhuis
city: Verviers
country: Belgium
facility: CH Peltzer-Tourelle
city: Yvoir
country: Belgium
facility: Avenue G Therasse 1
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: