Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis
This study is currently recruiting participants.
Verified October 2012 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00544557
First received: October 15, 2007
Last updated: October 11, 2012
Last verified: October 2012
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Purpose
Detailed Description:
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:
Genetics Home Reference related topics:
ankylosing spondylitis
MedlinePlus related topics:
Ankylosing Spondylitis
U.S. FDA Resources
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: | October 2012 |
Estimated Primary Completion Date: | October 2012 (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
Contacts
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
Germany | |
Pfizer Investigational Site | Recruiting |
Berlin, Germany, 12200 |
Sponsors and Collaborators
Pfizer
Investigators
Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
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: | October 11, 2012 |
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 October 17, 2012