Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01188655
• Date of registration: 24/08/2010
• Primary sponsor: Pfizer
• Public title: Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis
• Scientific title: Observational Non-Interventional Study With Enbrel in Patients With Ankylosing Spondylitis
• Date of first enrolment: May 2008
• Target sample size: 89
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01188655
• Study type: Observational
• Study design: Observational Model: Case-Only, Time Perspective: Prospective

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Proven diagnosis of Ankylosing Spondylitisin accordance with local guidelines

- Patients treated as an outpatient

Exclusion Criteria:

- Patients who suffer from hypersensitivity to the active substance Etanercept or to
any of the excipients of Enbrel®.

- Treatment with Enbrel® should not be initiated in patients with active infections
including chronic or localised infections.

- Patients with sepsis or risk of sepsis should not be treated.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Spondylitis, Ankylosing

Intervention(s)

Drug: Enbrel

Primary Outcome(s)

Percentage of Participants Achieving BASDAI 40 Response at Week 24 [Time Frame: Week 24]

Secondary Outcome(s)

Change From Baseline in ASQoL at Week 12 and Week 24 [Time Frame: Baseline, Week 12 and Week 24]

Change From Baseline in BASDAI at Week 12 and 24 [Time Frame: Baseline, Week 12 and Week 24]

Change From Baseline in the BASFI at Weeks 12 and 24 [Time Frame: Baseline, Week 12 and Week 24]

Mean Duration of Morning Stiffness [Time Frame: Week 12 and Week 24]

Mean Occiput-to-wall Distance at Week 12 and Week 24 [Time Frame: Week 12 and Week 24]

Participant's Global Assessment Visual Analog Scale at Weeks 12 and 24 [Time Frame: Week 12 and Week 24]

Percentage of Participants Without Enthesitis [Time Frame: Week 12 and Week 24]

Percentage of Participants Without Peripheral Arthritis [Time Frame: Week 12 and Week 24]

Physician's Global Assessment Visual Analog Scale at Weeks 12 and 24 [Time Frame: Week 12 and Week 24]

Spine Agility Function by Ott Test [Time Frame: Week 12 and Week 24]

Spine Agility Function by Schober Test [Time Frame: Week 12 and Week 24]

Secondary ID(s)

0881X1-4456

B1801095

Source(s) of Monetary Support

Please refer to primary and secondary sponsors