Defining Remission With Etanercept in AS in Real Life Clinical Practice

Ankylosing Spondylitis Clinical Trial

— REACH AS  

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))

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02202850
• Other study ID #: B1801379
• Secondary ID: B1801379REACH-AS
• Status: Completed
• Start date: August 12, 2014
• Est. completion date: April 26, 2017

Study information

• Verified date: April 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Determine which remission criterion at Month 6 predicts remission at Month 12 the best.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: April 26, 2017
• Est. primary completion date: April 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• etanercept
etanercept 1 x 50 mg/week or 2 x 25mg/week
• etanercept
etanercept 1 x 50 mg/week or 2 x 25mg/week

Locations

Country	Name	City	State
Belgium	Algemeen Stedelijk Ziekenhuis	Aalst
Belgium	ASZ Aalst	Aalst
Belgium	Onze Lieve Vrouw Ziekenhuis	Aalst
Belgium	Onze Lieve Vrouw Ziekenhuis Aalst	Aalst
Belgium	Private Practice	Braine L'alleud
Belgium	CHU St-Pierre	Brussel
Belgium	CHIREC	Brussels
Belgium	CHU Brugmann - Site Horta	Brussels	Bruxelles-capitale, Région DE
Belgium	Private Practice	Champion
Belgium	AZ Sint Blasius	Dendermonde
Belgium	Private Practice	Flemalles Haute
Belgium	Biomedical Research Institute/ Department of Rheumatology	Genk
Belgium	Private Practice	Genk
Belgium	Private Practice Rheumatology	Genk
Belgium	ReumaClinic	Genk
Belgium	Reumatologie Associatie	Genk
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Grand Hopital de Charleroi	Gilly
Belgium	Private Practice	Grand-Manil
Belgium	AZ Groeninge Campus Sint Maarten	Kortrijk
Belgium	CHU de Liège	Liege
Belgium	Private Practice of Dr. Geert Ghyselen	Lokeren
Belgium	Louisastraat 18	Mechelen
Belgium	Hôpital Sainte Thérèse/ Department of Rheumatology	Montignies-sur-Sambre
Belgium	Rheumatology	Oostende
Belgium	Office of Maenaut Kristien	Schoten
Belgium	Rheumatology	Sijsele-Damme
Belgium	Sint-Andries Ziekenhuis	Tielt
Belgium	Cliniques Universitaires UCL de Mont-Godinne	Yvoir

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission at Month 6 and Maintained Till Month 12	ASAS partial remission was defined as a score of less than or equal to (<=) 2 for each of the 4 items including pain, function, participant global assessment (PGA) and inflammation. All these items were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity.	Month 6 up to Month 12
Primary	Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 6 and Maintained Till Month 12	ASAS 5/6 was defined as at least greater than or equal to (>=) 20 percent relative improvement from baseline in at least 5 of the 6 following items: PGA, pain, function, inflammation, C - reactive protein (CRP) and spinal mobility. PGA, pain, function, inflammation all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. CRP was measured in milligrams per liter (mg/L) and spinal mobility was measured in centimeter (cm) as calculated as the mean of right and left measurements of lateral spinal flexion.	Month 6 up to Month 12
Primary	Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 6 and Maintained Till Month 12	ASAS 60 was defined as at least >= 60 percent relative improvement from baseline and an absolute change >=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).	Month 6 up to Month 12
Primary	Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 6 and Maintained Till Month 12	ASAS 40 was defined as at least >= 40 percent relative improvement from baseline and an absolute change >=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).	Month 6 up to Month 12
Primary	Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 6 and Maintained Till Month 12	BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity. BASDAI 50 remission was defined as at least >=50 percent relative improvement from baseline in BASDAI total score.	Month 6 up to Month 12
Primary	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	ASDAS-CRP was based on 3 domains: BASDAI, Bath Ankylosing Spondylitis Global score (BAS-G) and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of <1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.	Month 6 up to Month 12
Primary	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	ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of <1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.	Month 6 up to Month 12
Secondary	Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12	ASAS partial remission was defined as a score of <= 2 for each of the 4 items including pain, function, PGA and inflammation. All these items were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity.	Month 3, 6, 9 and 12
Secondary	Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12	ASAS 5/6 was defined as at least >= 20 percent relative improvement from baseline in at least 5 of the 6 following items: PGA, pain, function, inflammation, CRP and spinal mobility. PGA, pain, function, inflammation all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. CRP was measured in mg/L and spinal mobility was measured in centimeter as calculated as the mean of right and left measurements of lateral spinal flexion.	Month 3, 6, 9 and 12
Secondary	Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12	ASAS 60 was defined as at least >= 60 percent relative improvement from baseline and an absolute change >=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).	Month 3, 6, 9 and 12
Secondary	Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12	ASAS 40 was defined as at least >= 40 percent relative improvement from baseline and an absolute change >=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).	Month 3, 6, 9 and 12
Secondary	Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12	BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity. BASDAI 50 remission was defined as at least >=50 percent relative improvement from baseline in BASDAI total score.	Month 3, 6, 9 and 12
Secondary	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	ASDAS-CRP was based on 3 domains: BASDAI, BAS-G and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of <1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.	Month 3, 6, 9 and 12
Secondary	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	ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of <1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.	Month 3, 6, 9 and 12
Secondary	Change From Baseline in Participant Global Assessment (PGA) Score at Month 6 and 12	Participants were asked to assess their disease activity on an 11-point scale of 0 (no disease activity) to 10 (extreme disease activity), where higher score indicated higher disease activity.	Baseline, Month 6 and 12
Secondary	Change From Baseline in Pain Score of Ankylosing Spondylitis at Month 6 and 12	Pain score is used to determine disease activity in participants with AS by measuring participants pain and swelling, on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/swelling. The total pain score was calculated as average of these 2 items and ranged from 0= none to 10= severe, where higher score indicated higher degree of pain in participant due to AS.	Baseline, Month 6 and 12
Secondary	Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Month 6 and 12	BASFI was a functional index which included 10 items assessing ability of participants to perform normal daily activities. Each item was scored on a scale of 0=easy, to 10=impossible. The BASFI total score was calculated as the average score of these 10 individual items. BASFI total score ranged from 0 to 10, where higher scores indicated more severe disease activity.	Baseline, Month 6 and 12
Secondary	Change From Baseline in Inflammation Score of Ankylosing Spondylitis at Month 6 and 12	Inflammation score is used to determine disease activity in participants with AS by measuring intensity and duration of inflammation, on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of inflammation. The total inflammation score was calculated as average of these 2 items and ranged from 0= none to 10= severe, where higher score indicated higher degree of inflammation in participant due to AS.	Baseline, Month 6 and12
Secondary	Change From Baseline in C-Reactive Protein (CRP) at Month 6 and 12	CRP is a protein marker in the blood for inflammation.	Baseline, Month 6 and 12
Secondary	Change From Baseline in Spinal Mobility Measurement at Month 6 and 12	Spinal mobility was the mean of right and left measurements of lateral spinal flexion in centimeters.	Baseline, Month 6 and 12
Secondary	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Month 6 and 12	BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity.	Baseline, Month 6 and 12
Secondary	Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) at Month 6 and 12	ASDAS-CRP was based on 3 domains: BASDAI, BAS-G and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of <1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.	Baseline, Month 6 and 12
Secondary	Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) at Month 6 and 12	ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of <1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.	Baseline, Month 6 and 12

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