Clinical trial NCT00488475: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-20
Enrollment: 4945
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of rheumatoid arthritis

Exclusion Criteria:

* Sepsis or risk for sepsis,
* Acute infection,
* Hypersensitivity against Etanercept

Primary outcomes:
measure: Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 26
timeFrame: Week 26
measure: Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
timeFrame: Baseline, Week 26, Week 52
measure: Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)
timeFrame: Baseline, Week 26, Week 52
measure: Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP)
timeFrame: Baseline, Week 26, Week 52
measure: Healthcare Resource Utilization
timeFrame: Baseline, Week 26, Week 52
measure: Duration of Healthcare Resources Utilization
timeFrame: Baseline, Week 26, Week 52
measure: Duration of Working Disability
timeFrame: Baseline, Week 26, Week 52
measure: Disease Activity Score Based on 28-Joints Count (DAS28)
timeFrame: Baseline, Week 2, 6, 12, 26, 38, 52
measure: Swollen Joints Count (SJC)
timeFrame: Baseline, Week 2, 6, 12, 26, 38, 52
measure: Tender Joints Count (TJC)
timeFrame: Baseline, Week 2, 6, 12, 26, 38, 52
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: Baseline, Week 2, 6, 12, 26, 38, 52
measure: Percentage of Participants With Remission Determined by Disease Activity Score Based on 28-Joints Count (DAS 28)
timeFrame: Week 2, 6, 12, 26, 38, 52
measure: Percentage of Participants With Response Determined by Disease Activity Score Based on 28-Joints Count (DAS 28)
timeFrame: Week 2, 6, 12, 26, 38, 52
measure: Duration of Morning Stiffness
timeFrame: Baseline, Week 2, 6, 12, 26, 38, 52
measure: Patient Global Assessment of Arthritis Pain
timeFrame: Baseline, Week 2, 6, 12, 26, 38, 52
measure: Physician Global Assessment of Disease Activity
timeFrame: Baseline, Week 2, 6, 12, 26, 38, 52
measure: Patient Global Assessment of Disease Activity
timeFrame: Baseline, Week 2, 6, 12, 26, 38, 52
measure: C-Reactive Protein (CRP)
timeFrame: Baseline, Week 2, 6, 12, 26, 38, 52
measure: Fatigue Visual Analog Scale (VAS)
timeFrame: Baseline, Week 26, 52
Other outcomes:
measure: Percentage of Participants With Low Disease Activity Determined by Disease Activity Score 28 Based on 28-joints Count (DAS 28)
timeFrame: Week 2, 6, 12, 26, 38, 52
measure: Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Week 2 up to Week 52
measure: Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) With or Without Concomitant Methotrexate (MTX) Therapy
timeFrame: Week 2 up to Week 52
Locations:
city: Muenster
country: Germany
facility: Pfizer Investigational Site
state: NRW
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.