Characterize Patients With Moderately Active Rheumatoid Arthritis (RA)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01557322
First received: February 8, 2012
Last updated: January 31, 2013
Last verified: January 2013
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Purpose
- To assess the baseline (i.e. RA therapy initiation) characteristics in a real-world setting across two moderate RA cohorts: a Test Group of patients newly exposed to etanercept (Enbrel) therapy and a Control Group of patients with similar disease characteristics newly exposed to other, non-biologic therapies.
- To assess the change over time (from baseline to the most recent follow-up) in the characteristics described at baseline in 2 British Society for Rheumatology Biologics Register (BSRBR) cohorts (i.e. moderate RA patients treated with Disease modifying anti-rheumatic drugs (DMARDs) alone versus moderate RA patients treated with Enbrel).
| Condition | Intervention |
|---|---|
|
Rheumatoid Arthritis |
Biological: etanercept Drug: methotrexate (MTX) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Evaluation of the Clinical Characteristics, Real-world Treatment Pathways, and Outcomes of Patients With Moderate Rheumatoid Arthritis |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change from Baseline at 6 months in Disease Activity Score Based on 28-joints Count (DAS28) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
- Change from Baseline at 6 months in Health Assessment Questionnaire [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
- Change from Baseline at 6 months 36-Item Short-Form Health Survey (SF-36) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
- Change from Baseline at 6 months Euro Quality of Life (EQ-5D) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 1754 |
| Study Start Date: | October 2011 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Biologic |
Biological: etanercept
This is a Non-interventional study. The data is being analyzed retrospectively. The data consists of 2 cohorts; biologic and non-biologic
Other Name: Enrel
|
| non-biologic DMARD |
Drug: methotrexate (MTX)
This is a Non-interventional study. The data is being analyzed retrospectively. The data consists of 2 cohorts; biologic and non-biologic
Other Name: non-biologic DMARD
|
Detailed Description:
Retrospective database analysis
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
The BSR Biologics Register tracks the progress of patients with severe rheumatoid arthritis and other rheumatic conditions who are taking biologic therapy and those who are biologic naive.
Criteria
Inclusion Criteria:
The Test Group will be patients with rheumatoid arthritis, newly starting therapy with etanercept (Enbrel). Inclusion criteria for the exposed cohort subjects are:
- Patients aged 18 years and over at the time of diagnosis;
- Patients from the BSRBR with moderate RA as defined by a DAS28 (>3.2 and ≤5.1);
- Patients who have given informed consent for long term follow-up and access to all medical records;
- Patients initiating (i.e. at leats one treatment) treatment with etanercept (Enbrel) for RA.
The Control Group:
- Patients aged 18 years and over a the time of diagnosis;
- Patients from the BSRBR with moderate RA as defined by a DAS28 (>3.2 and ≤5.1);
- Patients who have given informed consent for long term follow-up and access to all medical records; Patients are receiving at least one traditional DMARD and have never been prescribed a biologic agent;
Exclusion Criteria:
Per BSRBR registry since data is retropsectively being analyzed
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01557322 History of Changes |
| Other Study ID Numbers: | B1801345 |
| Study First Received: | February 8, 2012 |
| Last Updated: | January 31, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate TNFR-Fc fusion protein Antirheumatic Agents Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Nucleic Acid Synthesis Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
ClinicalTrials.gov processed this record on May 22, 2013