Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00544557
First received: October 15, 2007
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Ankylosing Spondylitis
Drug: Etanercept

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A 1 Year Observational Study Of The Use Of Etanercept In Routine German Clinical Practice To Treat Ankylosing Spondylitis (AS) Patients: An Effectiveness, Safety And Health Economic Evaluation

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Proportion of patients achieving remission determined by ASAS criteria for partial remission [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determination of adverse events (AE) and serious adverse events (SAE) rates on etanercept therapy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Determination of differents in AE rates between patients with specific co-morbidities, such as cardiovascular disease and metabolic disorders [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Assessment of patient outcome [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Assessment of work disability domains [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1800
Study Start Date: November 2007
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with Ankylosing Spondylitis Drug: Etanercept
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.
Other Name: Enbrel

Detailed Description:

Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with an established diagnosis of Ankylosing Spondylitis

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00544557

Locations
Germany
Pfizer Investigational Site
Berlin, Germany, 12200
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00544557     History of Changes
Other Study ID Numbers: 0881X1-4463, B1801087
Study First Received: October 15, 2007
Last Updated: April 11, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014