Observational Trial With Enbrel

NCT00488475 | Completed Results

• 2 other identifiers: 0881A1-102335B1801121
• Study Type: observational
• Target: 4,945
• Locations: 1 country
• Sites: 1

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).

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 26

  Hannover Functional Ability Questionnaire (FFbH) consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) is then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranging between 0-100; higher score indicates better daily activities. FFbH functional remission is defined as FFbH functional capacity of \>= 83%.

  Week 26

• Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 52

  Hannover Functional Ability Questionnaire (FFbH) consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) is then computed according to formula: (Sum of all single scores \* 100%) / (2 \* number of answered questions), ranging between 0-100; higher score indicates better daily activities. FFbH functional remission is defined as FFbH functional capacity of \>= 83%.

  Week 52

Secondary Outcomes (18)

• Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)

  Baseline, Week 26, Week 52

• Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)

  Baseline, Week 26, Week 52

• Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP)

  Baseline, Week 26, Week 52

• Healthcare Resource Utilization

  Baseline, Week 26, Week 52

• Duration of Healthcare Resources Utilization

  Baseline, Week 26, Week 52

Other Outcomes (3)

• Percentage of Participants With Low Disease Activity Determined by Disease Activity Score 28 Based on 28-joints Count (DAS 28)

  Week 2, 6, 12, 26, 38, 52

• Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

  Week 2 up to Week 52

• Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) With or Without Concomitant Methotrexate (MTX) Therapy

  Week 2 up to Week 52

Study Arms (1)

Patients with Rheumatoid Arthritis

Drug: etanercept

Interventions

etanercept DRUG

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.

Also known as: Enbrel

Patients with Rheumatoid Arthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Clinical diagnosis of rheumatoid arthritis

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Münster, North Rhine-Westphalia, 48149, Germany

Location

Related Publications (1)

• 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.

  PMID: 29843776 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Limitations and Caveats

Prioritization of endpoints as primary or secondary was not specified in protocol and was based on study team's inputs.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2007
• First Posted: June 20, 2007
• Study Start: September 1, 2006
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 1, 2014
• Results First Posted: May 15, 2014

Record last verified: 2014-07

Locations

DE (1)