Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Dermatologists
This study is ongoing, but not recruiting participants.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00293709
First received: February 15, 2006
Last updated: May 14, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to evaluate the safety profile and the effectiveness of etanercept under usual care settings in patients with PsA treated by dermatologists.
| Condition | Intervention |
|---|---|
|
Arthritis, Psoriatic Psoriasis Skin Diseases, Papulosquamous |
Drug: etanercept |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prospective Post Marketing Surveillance To Evaluate The Safety And Efficacy Of Etanercept Under Usual Care Settings In Patients With Psoriatic Arthritis (Psa) Treated By Dermatologists |
Resource links provided by NLM:
Genetics Home Reference related topics:
psoriatic arthritis
Drug Information available for:
Etanercept
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary 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 ]
Secondary Outcome Measures:
- Determination of response rate to Enbrel® in patients with Psoriatic Arthritis treated in a real life setting [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Patients with Psoriatic Arthritis |
Drug: etanercept
The patients will be treated in accordance with the requirements of the labelling of Enbrel® 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
Only patients for whom the decision has already been made to initiate treatment with Enbrel® can be enrolled in this observational trial. These patients must have a proven diagnosis of Psoriatic Arthritis.
Criteria
Inclusion Criteria:
- Clinical diagnosis of Psoriatic Arthritis
Exclusion Criteria:
- Sepsis or risk for sepsis,
- Acute infection,
- Hypersensitive against Etanercept
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00293709 History of Changes |
| Other Study ID Numbers: | 0881A6-102036, B1801126 |
| Study First Received: | February 15, 2006 |
| Last Updated: | May 14, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Pfizer:
|
Arthritis |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Psoriatic Psoriasis Skin Diseases Skin Diseases, Papulosquamous Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spondylitis Spinal Diseases Bone Diseases 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 May 21, 2013