Defining Remission With Etanercept in AS in Real Life Clinical Practice

NCT02202850 | Completed Results

• 2 other identifiers: B1801379REACH-AS
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 29

Brief Summary

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

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (16)

• Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12

  Month 3, 6, 9 and 12

• Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12

  Month 3, 6, 9 and 12

• Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12

  Month 3, 6, 9 and 12

• Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12

  Month 3, 6, 9 and 12

• Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12

  Month 3, 6, 9 and 12

Study Arms (2)

Etanercept First

Adults patients with AS receiving Etanercept as first biologic, according to prevailing reimbursement criteria in Belgium

Drug: etanercept

Etanercept second

Adults patients with AS receiving Etanercept as second biologic, according to prevailing reimbursement criteria in Belgium

Drug: etanercept

Interventions

etanercept DRUG

etanercept 1 x 50 mg/week or 2 x 25mg/week

Etanercept First

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients with AS who start treatment with Etanercept according to prevailing reimbursement criteria and dosing in line with SmPC.
• First cohort: Etanercept is the first biological product prescribed
• Second cohort: Etanercept is the second biological product prescribed
• Capable of understanding and willing to provide signed and dated written, voluntary informed consent before any protocol-specific procedures are performed.
• years of age or older at time of consent
• 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.

You may not qualify if:

• \. History of or current psychiatric illness that would interfere with the subject's ability to comply with protocol requirements or to give informed consent.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (29)

CHU Brugmann - Site Horta

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

Location

ASZ Aalst

Aalst, 9300, Belgium

Location

Algemeen Stedelijk Ziekenhuis

Aalst, B-9300, Belgium

Location

Onze Lieve Vrouw Ziekenhuis Aalst

Aalst, B-9300, Belgium

Location

Onze Lieve Vrouw Ziekenhuis

Aalst, B-9300, Belgium

Location

Private Practice

Braine-l'Alleud, B-1420, Belgium

Location

CHIREC

Brussels, 1040, Belgium

Location

CHU St-Pierre

Brussels, B-1000, Belgium

Location

Private Practice

Champion, B-5020, Belgium

Location

AZ Sint Blasius

Dendermonde, 9200, Belgium

Location

Private Practice

Flemalles Haute, B-4400, Belgium

Location

Biomedical Research Institute/ Department of Rheumatology

Genk, 3600, Belgium

Location

Private Practice Rheumatology

Genk, 3600, Belgium

Location

ReumaClinic

Genk, 3600, Belgium

Location

Reumatologie Associatie

Genk, 3600, Belgium

Location

Private Practice

Genk, B-3600, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Grand Hopital de Charleroi

Gilly, B-6060, Belgium

Location

Private Practice

Grand-Manil, 5030, Belgium

Location

AZ Groeninge Campus Sint Maarten

Kortrijk, Belgium

Location

CHU de Liège

Liège, B-4000, Belgium

Location

Private Practice of Dr. Geert Ghyselen

Lokeren, 9160, Belgium

Location

Louisastraat 18

Mechelen, 2800, Belgium

Location

Hôpital Sainte Thérèse/ Department of Rheumatology

Montignies-sur-Sambre, 6061, Belgium

Location

Rheumatology

Ostend, 8400, Belgium

Location

Office of Maenaut Kristien

Schoten, B-2900, Belgium

Location

Rheumatology

Sijsele-Damme, 8340, Belgium

Location

Sint-Andries Ziekenhuis

Tielt, B-8700, Belgium

Location

Cliniques Universitaires UCL de Mont-Godinne

Yvoir, 5530, Belgium

Location

Related Links

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

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquires@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 29, 2014
• Study Start: August 12, 2014
• Primary Completion: April 26, 2017
• Study Completion: April 26, 2017
• Last Updated: November 30, 2018
• Results First Posted: November 30, 2018

Record last verified: 2018-04

Locations

BE (29)