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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02202850
Other study ID # B1801379
Secondary ID B1801379REACH-AS
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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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