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| Sponsor: | Wyeth is now a wholly owned subsidiary of Pfizer |
|---|---|
| Information provided by (Responsible Party): | Wyeth is now a wholly owned subsidiary of Pfizer |
| ClinicalTrials.gov Identifier: | NCT00273858 |
Purpose
This is a Phase 4 open label, non-interventional, multi-center study to evaluate the safety of Enbrel (etanercept) treatment in patients receiving etanercept 25mg sc twice weekly or 50mg of etanercept once weekly. The improvement of health-related quality of life will also be evaluated.
| Condition | Intervention |
|---|---|
|
Ankylosing Spondylitis Arthritis, Psoriatic Arthritis, Rheumatoid Spondylitis, Ankylosing |
Other: There is no Intervention. The study is observational. |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Open Label Study To Evaluate The Safety Profile And The Quality Of Life In Patients Receiving Etanercept For The Treatment Of Rheumatoid Arthritis, Ankylosing Spondylitis And Psoriatic Arthritis |
| Enrollment: | 880 |
| Study Start Date: | March 2006 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
etanercept
Patients already prescribed to receive etanercept for the first time for treatment of Rheumatoid Arthritis, Ankylosing Spondylitis or Psoriatic Arthritis according to the Summary of Product Characteristics (SmPC).
|
Other: There is no Intervention. The study is observational.
The study is observational and the prescription follows the SmPC of etanercept.
|
Patients already prescribed to receive etanercept for the first time for treatment of Rheumatoid Arthritis, Ankylosing Spondylitis or Psoriatic Arthritis according to the Summary of Product Characteristics (SmPC).
Patients have been recruited sequentially based on eligibility criteria up to the number limit assigned to each site.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Rheumatoid Arthritis Patients, Psoriatic Arthritis Patients, Ankylosing Spondylitis Patients
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Greece | |
| Pfizer Investigational Site | |
| Thessaloniki, Asvestohori, Greece, 570 10 | |
| Pfizer Investigational Site | |
| Athens, Maroussi, Greece, 145 61 | |
| Pfizer Investigational Site | |
| Athens, Greece, 16673 | |
| Pfizer Investigational Site | |
| Athens, Greece, 115 26 | |
| Pfizer Investigational Site | |
| Athens, Greece, 115 27 | |
| Pfizer Investigational Site | |
| Athens, Greece, 184 54 | |
| Pfizer Investigational Site | |
| Karditsa, Greece, 43100 | |
| Pfizer Investigational Site | |
| Larissa, Greece, 411 10 | |
| Pfizer Investigational Site | |
| Thessaloniki, Greece, 546 42 | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Wyeth is now a wholly owned subsidiary of Pfizer |
| ClinicalTrials.gov Identifier: | NCT00273858 History of Changes |
| Other Study ID Numbers: | 0881A-101695, B1801106 |
| Study First Received: | January 4, 2006 |
| Results First Received: | June 30, 2011 |
| Last Updated: | September 8, 2011 |
| Health Authority: | Greece: National Organization of Medicines |
|
Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis |
|
Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Spondylitis Spondylitis, Ankylosing Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spinal Diseases Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases Rheumatic Diseases |
Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Bone Diseases, Infectious Infection Ankylosis 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 |