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

NCT01188655 | Completed Results

• 2 other identifiers: 0881X1-4456B1801095
• Study Type: observational
• Target: 89
• Locations: 0 countries
• Sites: N/A

Brief Summary

This observational study will be a documentation of the prescribing and administration practices of Enbrel® and their impact on ankylosing spondylitis patients outcome in a real life setting.

Conditions

Spondylitis, Ankylosing

Keywords

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving BASDAI 40 Response at Week 24

  BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10. Participants who achieved a decrease of 40 percent or more from baseline to the following visits are called as responders.

  Week 24

Secondary Outcomes (11)

• Change From Baseline in BASDAI at Week 12 and 24

  Baseline, Week 12 and Week 24

• Change From Baseline in the BASFI at Weeks 12 and 24

  Baseline, Week 12 and Week 24

• Participant's Global Assessment Visual Analog Scale at Weeks 12 and 24

  Week 12 and Week 24

• Physician's Global Assessment Visual Analog Scale at Weeks 12 and 24

  Week 12 and Week 24

• Mean Duration of Morning Stiffness

  Week 12 and Week 24

Study Arms (1)

Treatment Group Enbrel

Drug: Enbrel

Interventions

Enbrel DRUG

The patients will be treated in accordance with the requirements of the labeling of Enbrel® in Austria. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment. To record complete dosing information, initial dose will be documented at baseline and any change will be documented with date, dose and reason at the subsequent visits.

Also known as: etanercept

Treatment Group Enbrel

Eligibility Criteria

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

Study Population

The patient cohort in this non-interventional study will reflect the kind of patients seen in routine clinical practice and will not be specifically pre-selected as it is the case in clinical studies.

You may qualify if:

• Proven diagnosis of Ankylosing Spondylitisin accordance with local guidelines
• Patients treated as an outpatient

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

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_Inquiries@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: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2010
• First Posted: August 25, 2010
• Study Start: May 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: September 12, 2011
• Results First Posted: April 26, 2011

Record last verified: 2011-09