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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00544557
Date of registration: 15/10/2007
Prospective Registration: No
Primary sponsor: Pfizer
Public title: Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis
Scientific 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
Date of first enrolment: October 2007
Target sample size: 1715
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00544557
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Germany
Contacts
Name:     Pfizer CT.gov Call Center
Address: 
Telephone:
Email:
Affiliation:  Pfizer
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Ankylosing Spondylitis
Intervention(s)
Drug: Etanercept
Primary Outcome(s)
Percentage of Participants Achieving Partial Remission at Week 52 [Time Frame: Week 52]
Percentage of Participants Achieving Partial Remission at Week 26 [Time Frame: Week 26]
Secondary Outcome(s)
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52 [Time Frame: Baseline, Week 52]
Change From Baseline in Duration of Morning Stiffness at Week 52 [Time Frame: Baseline, Week 52]
Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) [Time Frame: Baseline up to Week 52]
Change From Baseline in Lateral Lumbar Flexion at Week 52 [Time Frame: Baseline, Week 52]
Percentage of Participants With Presence of Enthesitis [Time Frame: Baseline, Week 2, 6, 12, 26, 38, 52]
Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) by Co-morbidity [Time Frame: Baseline up to Week 52]
Change From Baseline in Number of Affected Joints by Peripheral Arthritis at Week 52 [Time Frame: Baseline, Week 52]
Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 52 [Time Frame: Baseline, Week 52]
Change From Baseline in Occiput-to-Wall Distance at Week 52 [Time Frame: Baseline, Week 52]
Healthcare Resource Utilization [Time Frame: Baseline, Week 26, 52]
Percentage of Participants With Assessment in Ankylosing Spondylitis 40 (ASAS-40) Response [Time Frame: Week 12, 26, 38, 52]
Percentage of Participants With Discontinuation of Treatment Due to Adverse Events [Time Frame: Baseline up to Week 52]
Percentage of Participants With Presence of Peripheral Arthritis [Time Frame: Baseline, Week 2, 6, 12, 26, 38, 52]
Percentage of Participants With Significant Reduction of Morning Stiffness [Time Frame: Week 2, 6, 12, 26, 38, 52]
Euro Quality of Life (EQ--5D)- Visual Analog Scale (VAS) [Time Frame: Baseline, Week 26, 52]
Percentage of Participants With Assessment in Ankylosing Spondylitis 20 (ASAS-20) Response [Time Frame: Week 12, 26, 38, 52]
Change From Baseline in Number of Affected Body Parts by Enthesitis at Week 52 [Time Frame: Baseline, Week 52]
Change From Baseline in Patient's Global Assessment (PtGA) of Pain at Week 52 [Time Frame: Baseline, Week 52]
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52 [Time Frame: Baseline, Week 52]
Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) [Time Frame: Baseline, Week 26, 52]
Change From Baseline in C-Reactive Protein (CRP) at Week 52 [Time Frame: Baseline, Week 52]
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52 [Time Frame: Baseline, Week 52]
Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity at Week 52 [Time Frame: Baseline, Week 52]
Duration of Healthcare Resources Utilization [Time Frame: Baseline, Week 26, 52]
Percentage of Participants With Prior or Concomitant Medication Use for Treatment of Ankylosing Spondylitis [Time Frame: Baseline up to Week 52]
Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP) [Time Frame: Baseline, Week 26, 52]
Secondary ID(s)
0881X1-4463
B1801087
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 12/05/2015
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00544557
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