Defining Remission With Etanercept in AS in Real Life Clinical Practice (REACH AS)

• ClinicalTrials.gov Identifier: NCT02202850
• Recruitment Status: Completed
• First Posted: July 29, 2014
• Results First Posted: November 30, 2018
• Last Update Posted: November 30, 2018
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Ankylosing Spondylitis	Drug: 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 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 84 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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))
• Actual Study Start Date: August 12, 2014
• Actual Primary Completion Date: April 26, 2017
• Actual Study Completion Date: April 26, 2017

Groups and Cohorts

Group/Cohort	Intervention/treatment
Etanercept First; Adults patients with AS receiving Etanercept as first biologic, according to prevailing reimbursement criteria in Belgium	Drug: etanercept; etanercept 1 x 50 mg/week or 2 x 25mg/week
Etanercept second; Adults patients with AS receiving Etanercept as second biologic, according to prevailing reimbursement criteria in Belgium	Drug: etanercept; etanercept 1 x 50 mg/week or 2 x 25mg/week

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission at Month 6 and Maintained Till Month 12 [ Time Frame: Month 6 up to 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.
2. Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 6 and Maintained Till Month 12 [ Time Frame: Month 6 up to 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.
3. Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 6 and Maintained Till Month 12 [ Time Frame: Month 6 up to 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).
4. Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 6 and Maintained Till Month 12 [ Time Frame: Month 6 up to 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).
5. Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 6 and Maintained Till Month 12 [ Time Frame: Month 6 up to 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.
6. 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 [ Time Frame: Month 6 up to 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.
7. 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 [ Time Frame: Month 6 up to 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.

Secondary Outcome Measures :

1. Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12 [ Time Frame: 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.
2. Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12 [ Time Frame: 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.
3. Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12 [ Time Frame: 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).
4. Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12 [ Time Frame: 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).
5. Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12 [ Time Frame: 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.
6. 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 [ Time Frame: 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.
7. 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 [ Time Frame: 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.
8. Change From Baseline in Participant Global Assessment (PGA) Score at Month 6 and 12 [ Time Frame: Baseline, 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.
9. Change From Baseline in Pain Score of Ankylosing Spondylitis at Month 6 and 12 [ Time Frame: Baseline, 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.
10. Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Month 6 and 12 [ Time Frame: Baseline, 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.
11. Change From Baseline in Inflammation Score of Ankylosing Spondylitis at Month 6 and 12 [ Time Frame: Baseline, Month 6 and12 ]
    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.
12. Change From Baseline in C-Reactive Protein (CRP) at Month 6 and 12 [ Time Frame: Baseline, Month 6 and 12 ]
    CRP is a protein marker in the blood for inflammation.
13. Change From Baseline in Spinal Mobility Measurement at Month 6 and 12 [ Time Frame: Baseline, Month 6 and 12 ]
    Spinal mobility was the mean of right and left measurements of lateral spinal flexion in centimeters.
14. Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Month 6 and 12 [ Time Frame: Baseline, 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.
15. Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) at Month 6 and 12 [ Time Frame: Baseline, 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.
16. Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) at Month 6 and 12 [ Time Frame: Baseline, 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Patients visiting Rheumatologist for which the decision has been taken to prescribe Etanercept as first or second line

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.

Contacts and Locations

Locations

Belgium

CHU Brugmann - Site Horta

Brussels, Bruxelles-capitale, Région DE, Belgium, 1020

ASZ Aalst

Aalst, Belgium, 9300

Algemeen Stedelijk Ziekenhuis

Aalst, Belgium, B-9300

Onze Lieve Vrouw Ziekenhuis Aalst

Aalst, Belgium, B-9300

Onze Lieve Vrouw Ziekenhuis

Aalst, Belgium, B-9300

Private Practice

Braine L'alleud, Belgium, B-1420

CHIREC

Brussels, Belgium, 1040

CHU St-Pierre

Brussel, Belgium, B-1000

Private Practice

Champion, Belgium, B-5020

AZ Sint Blasius

Dendermonde, Belgium, 9200

Private Practice

Flemalles Haute, Belgium, B-4400

Biomedical Research Institute/ Department of Rheumatology

Genk, Belgium, 3600

Private Practice Rheumatology

Genk, Belgium, 3600

ReumaClinic

Genk, Belgium, 3600

Reumatologie Associatie

Genk, Belgium, 3600

Private Practice

Genk, Belgium, B-3600

Universitair Ziekenhuis Gent

Gent, Belgium, 9000

Grand Hopital de Charleroi

Gilly, Belgium, B-6060

Private Practice

Grand-Manil, Belgium, 5030

AZ Groeninge Campus Sint Maarten

Kortrijk, Belgium

CHU de Liège

Liege, Belgium, B-4000

Private Practice of Dr. Geert Ghyselen

Lokeren, Belgium, 9160

Louisastraat 18

Mechelen, Belgium, 2800

Hôpital Sainte Thérèse/ Department of Rheumatology

Montignies-sur-Sambre, Belgium, 6061

Rheumatology

Oostende, Belgium, 8400

Office of Maenaut Kristien

Schoten, Belgium, B-2900

Rheumatology

Sijsele-Damme, Belgium, 8340

Sint-Andries Ziekenhuis

Tielt, Belgium, B-8700

Cliniques Universitaires UCL de Mont-Godinne

Yvoir, Belgium, 5530

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

  Study Documents (Full-Text)

Documents provided by Pfizer:

Study Protocol and Statistical Analysis Plan  [PDF] May 20, 2014

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02202850
• Other Study ID Numbers: B1801379; B1801379 ( Other Identifier: Alias Study Number ); REACH-AS ( Other Identifier: Alias Study Number )
• First Posted: July 29, 2014
• Results First Posted: November 30, 2018
• Last Update Posted: November 30, 2018
• Last Verified: April 2018

Additional relevant MeSH terms:

Spondylitis; Spondylitis, Ankylosing; Bone Diseases, Infectious; Infection; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spondylarthropathies; Spondylarthritis; Ankylosis; Joint Diseases; Arthritis; Etanercept; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Gastrointestinal Agents; Immunosuppressive Agents; Immunologic Factors