Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis

NCT00544557 | Completed Results

• 2 other identifiers: 0881X1-4463B1801087
• Study Type: observational
• Target: 1,715
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving Partial Remission at Week 26

  Percentage of participants achieving partial remission was determined by assessment of spondyloarthritis international society (ASAS) criteria. Partial remission was defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation.

  Week 26

• Percentage of Participants Achieving Partial Remission at Week 52

  Percentage of participants achieving partial remission was determined by ASAS criteria. Partial remission defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation.

  Week 52

Secondary Outcomes (26)

• Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)

  Baseline up to Week 52

• Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) by Co-morbidity

  Baseline up to Week 52

• Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52

  Baseline, Week 52

• Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52

  Baseline, Week 52

• Change From Baseline in Occiput-to-Wall Distance at Week 52

  Baseline, Week 52

Study Arms (1)

Patients with Ankylosing Spondylitis

Drug: Etanercept

Interventions

Etanercept DRUG

The patients will be treated in accordance with the requirements of the labeling of etanercept in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.

Also known as: Enbrel

Patients with Ankylosing Spondylitis

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

Patients with an established diagnosis of Ankylosing Spondylitis

You may qualify if:

• Diagnosis of ankylosing spondylitis (AS)

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Klinikum Benjamin Franklin

Berlin, 12200, Germany

Location

Related Publications (1)

• 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.

  PMID: 29843776 DERIVED

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: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2007
• First Posted: October 16, 2007
• Study Start: October 1, 2007
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 12, 2015
• Results First Posted: May 12, 2015

Record last verified: 2015-04

Locations

DE (1)