Clinical trial NCT01557322: Characterize Patients With Moderately Active Rheumatoid Arthritis (RA)
Official title: Evaluation of the Clinical Characteristics, Real-world Treatment Pathways, and Outcomes of Patients With Moderate Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-03-19
Enrollment: 1754
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 1. 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.
2. 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).

Detailed description: Retrospective database analysis

Eligibility 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

Primary outcomes:
measure: Number of Participants With American College of Rheumatology (ACR) Criteria
timeFrame: Baseline
measure: Number of Participants With Systemic Features
timeFrame: Baseline
measure: Number of Participants With Prior Joint Replacement or Surgery
timeFrame: Baseline
measure: Number of Participants With Chest X-Ray Prior to New Therapy
timeFrame: Baseline
measure: Number of Participants With Comorbidities
timeFrame: Baseline
measure: Body Mass Index (BMI)
timeFrame: Baseline
measure: Blood Pressure (BP)
timeFrame: Baseline
measure: Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 60
timeFrame: Baseline, Month 60
measure: Change From Baseline in Tender Joints Count (TJC) at Month 60
timeFrame: Baseline, Month 60
measure: Change From Baseline in Swollen Joints Count (SJC) at Month 60
timeFrame: Baseline, Month 60
measure: Change From Baseline in C-Reactive Protein (CRP) Level at Month 60
timeFrame: Baseline, Month 60
measure: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 60
timeFrame: Baseline, Month 60
measure: Change From Baseline in Patient's Global Assessment (PtGA) of Disease Activity at Month 60
timeFrame: Baseline, Month 60
measure: Duration of Disease (Rheumatoid Arthritis)
timeFrame: Baseline
measure: Time Since First Rheumatologist Visit
timeFrame: Baseline
measure: Time Since Recalled Symptom Onset
timeFrame: Baseline
measure: Number of Participants With Previous and Current Disease Modifying Anti-Rheumatic Drugs (DMARDs)
timeFrame: Baseline
measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Month 60
timeFrame: Baseline, Month 60
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 60
timeFrame: Baseline, Month 60
measure: Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D) at Month 60
timeFrame: Baseline, Month 60
measure: Time to Disease Worsening
timeFrame: Baseline up to Month 60
measure: Time to Therapeutic Goal
timeFrame: Baseline up to Month 60
measure: Change From Baseline in Pain Visual Analog Scale (VAS) Score at Month 60
timeFrame: Baseline, Month 60
measure: Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 60
timeFrame: Month 60
measure: Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 60
timeFrame: Month 60
measure: Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 60
timeFrame: Month 60
measure: Number of Rheumatoid Arthritis (RA) Related Visits
timeFrame: Baseline
measure: Direct and Indirect Cost of Rheumatoid Arthritis (RA) Treatment
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Month 6, 12, 18, 24, 30, 36, 48, 60
measure: Number of Participants With Malignancy
timeFrame: Month 6, 12, 18, 24, 30, 36, 48, 60
measure: Number of Participants Who Died or Hospitalized Due to Adverse Events
timeFrame: Month 6, 12, 18, 24, 30, 36, 48, 60
measure: Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D) at Month 6
timeFrame: Baseline, Month 6
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: