Clinical trial NCT00544557: Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis
Official title: Observational Study Of The Use Of Enbrel (Registered) (Etanercept) In Routine Clinical Practice To Treat Ankylosing Spondylitis (as) Patients: An Effectiveness, Safety, And Health Economic Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-10-16
Enrollment: 1715
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: Patients with an established diagnosis of Ankylosing Spondylitis

Brief summary: This study aims to provide a holistic assessment of patients receiving etanercept in a real-world setting.

Detailed description: Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Eligibility criteria: Inclusion Criteria:

* Diagnosis of ankylosing spondylitis (AS)

Exclusion Criteria:

* Hypersensitivity to etanercept
* Active infection including chronic or localised infection
* Sepsis or risk of sepsis

Primary outcomes:
measure: Percentage of Participants Achieving Partial Remission at Week 26
timeFrame: Week 26
measure: Percentage of Participants Achieving Partial Remission at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)
timeFrame: Baseline up to Week 52
measure: Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) by Co-morbidity
timeFrame: Baseline up to Week 52
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Occiput-to-Wall Distance at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Lateral Lumbar Flexion at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Patient's Global Assessment (PtGA) of Pain at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Duration of Morning Stiffness at Week 52
timeFrame: Baseline, Week 52
measure: Percentage of Participants With Significant Reduction of Morning Stiffness
timeFrame: Week 2, 6, 12, 26, 38, 52
measure: Percentage of Participants With Presence of Peripheral Arthritis
timeFrame: Baseline, Week 2, 6, 12, 26, 38, 52
measure: Change From Baseline in Number of Affected Joints by Peripheral Arthritis at Week 52
timeFrame: Baseline, Week 52
measure: Percentage of Participants With Presence of Enthesitis
timeFrame: Baseline, Week 2, 6, 12, 26, 38, 52
measure: Change From Baseline in Number of Affected Body Parts by Enthesitis at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in C-Reactive Protein (CRP) at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52
timeFrame: Baseline, Week 52
measure: Percentage of Participants With Assessment in Ankylosing Spondylitis 20 (ASAS-20) Response
timeFrame: Week 12, 26, 38, 52
measure: Percentage of Participants With Assessment in Ankylosing Spondylitis 40 (ASAS-40) Response
timeFrame: Week 12, 26, 38, 52
measure: Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)
timeFrame: Baseline, Week 26, 52
measure: Euro Quality of Life (EQ--5D)- Visual Analog Scale (VAS)
timeFrame: Baseline, Week 26, 52
measure: Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP)
timeFrame: Baseline, Week 26, 52
measure: Healthcare Resource Utilization
timeFrame: Baseline, Week 26, 52
measure: Duration of Healthcare Resources Utilization
timeFrame: Baseline, Week 26, 52
measure: Percentage of Participants With Prior or Concomitant Medication Use for Treatment of Ankylosing Spondylitis
timeFrame: Baseline up to Week 52
measure: Percentage of Participants With Discontinuation of Treatment Due to Adverse Events
timeFrame: Baseline up to Week 52
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Klinikum Benjamin Franklin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Druce KL, Aikman L, Dilleen M, Burden A, Szczypa P, Basu N. Fatigue independently predicts different work disability dimensions in etanercept-treated rheumatoid arthritis and ankylosing spondylitis patients. Arthritis Res Ther. 2018 May 29;20(1):96. doi: 10.1186/s13075-018-1598-8.