Last updated date
ABOUT THIS STUDY
The diagnosis, evaluation and treatment of rheumatoid arthritis (RA) continue to undergo
rapid change. Randomized controlled trials such as the TEMPO study have demonstrated the
efficacy and safety of the combination of etanercept and methotrexate. Importantly, the TEMPO
study showed that patients treated with etanercept and methotrexate could reach the newer
therapeutic goals of low disease activity and remission, and that the physicians, patients,
and payers are no longer prepared to accept the goal of "Reduction of symptoms". RCT are
important and powerful tools in assessing efficacy and safety but have their limitations in
terms of generalisability. In order to assess health economics, clinical effectiveness and
safety of etanercept, they need to be measured by performing observational studies of
unselected patients. This study aims to provide a holistic assessment of patients receiving
etanercept in a real world setting. This will include centers that would not normally take
part in RCT. The study will assess treatment with etanercept with descriptive statistics of
the following parameters: Health economic, Safety, Effectiveness. In addition, there was a
previous study of similar design, but of only 3 months duration (101354), which will allow
comparison with historical data. Since previous study, there have been a number of
significant changes: Introduction of a new formulation for etanercept (Enbrel® 50mg · once
weekly), Definition of early RA has been modified to short disease duration (from 3 months to
1 year).
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Rheumatoid Arthritis
Sex
Females and Males
Age
18 + years
Inclusion Criteria
Show details
- Clinical diagnosis of rheumatoid arthritis
Exclusion Criteria
Show details
- Sepsis or risk for sepsis,
- Acute infection,
- Hypersensitivity against Etanercept
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
Rheumatoid ArthritisEvaluation of Pain Sensitization in Rheumatoid Arthritis: Analysis on a Cohort of Tofacitinib Treated Patients
NCT03815578
- Bordeaux,
- Limoges,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Rheumatoid ArthritisCONfident Treatment Decisions in Living With Rheumatoid Arthritis
NCT03317756
- Birmingham, Alabama
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Rheumatoid ArthritisEffect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells
NCT03755297
- Montpellier,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Rheumatoid ArthritisRheumatoid Arthritis DMARD Intervention and UtilizationStudy
NCT00116727
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title | Observational Trial With Enbrel | |||
Official Title | A 1 Year Observational Study of the Use of Etanercept in Routine German Clinical Practice to Treat Rheumatoid Arthritis Patients: a Health Economic, Safety and Effectiveness Evaluation | |||
Brief Summary | The diagnosis, evaluation and treatment of rheumatoid arthritis (RA) continue to undergo rapid change. Randomized controlled trials such as the TEMPO study have demonstrated the efficacy and safety of the combination of etanercept and methotrexate. Importantly, the TEMPO study showed that patients treated with etanercept and methotrexate could reach the newer therapeutic goals of low disease activity and remission, and that the physicians, patients, and payers are no longer prepared to accept the goal of "Reduction of symptoms". RCT are important and powerful tools in assessing efficacy and safety but have their limitations in terms of generalisability. In order to assess health economics, clinical effectiveness and safety of etanercept, they need to be measured by performing observational studies of unselected patients. This study aims to provide a holistic assessment of patients receiving etanercept in a real world setting. This will include centers that would not normally take part in RCT. The study will assess treatment with etanercept with descriptive statistics of the following parameters: Health economic, Safety, Effectiveness. In addition, there was a previous study of similar design, but of only 3 months duration (101354), which will allow comparison with historical data. Since previous study, there have been a number of significant changes: Introduction of a new formulation for etanercept (Enbrel® 50mg · once weekly), Definition of early RA has been modified to short disease duration (from 3 months to 1 year). | |||
Detailed Description | Non-interventional study: subjects to be selected according to the usual clinical practice of their physician | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
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 Rheumatoid Arthritis | |||
Condition | Rheumatoid Arthritis | |||
Intervention | 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 | |||
Study Groups/Cohorts | Patients with Rheumatoid Arthritis
Intervention: Drug: etanercept | |||
Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment | 4945 | |||
Original Enrollment | Not Provided | |||
Actual Study Completion Date | April 2013 | |||
Actual Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender |
| |||
Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Germany | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00488475 | |||
Other Study ID Numbers | 0881A1-102335 B1801121 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
| |||
PRS Account | Pfizer | |||
Verification Date | July 2014 |