Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis

• 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

Countries of recruitment

Germany

Contacts

• Name: Pfizer CT.gov Call Center
• 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 26 [Time Frame: Week 26]

Percentage of Participants Achieving Partial Remission at Week 52 [Time Frame: Week 52]

Secondary Outcome(s)

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 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 Functional Index (BASFI) at Week 52 [Time Frame: Baseline, 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 Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52 [Time Frame: Baseline, Week 52]

Percentage of Participants With Presence of Peripheral Arthritis [Time Frame: Baseline, Week 2, 6, 12, 26, 38, 52]

Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) [Time Frame: Baseline, Week 26, 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 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]

Percentage of Participants With Significant Reduction of Morning Stiffness [Time Frame: Week 2, 6, 12, 26, 38, 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]

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]

Secondary ID(s)

B1801087

0881X1-4463

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/05/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00544557