N/A Completed N=1,754

Characterize Patients With Moderately Active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Source: ClinicalTrials.gov NCT01557322 ↗

Enrolled (actual)

1,754

Serious AEs

34.8%

Results posted

Oct 2013

Primary outcomePrimary: Number of Participants With American College of Rheumatology (ACR) Criteria — 194; 1316; 179; 1133 participants — p=0.010

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With American College of Rheumatology (ACR) Criteria	194; 1316; 179; 1133; 160; 1123	0.010 sig
PRIMARY Number of Participants With Systemic Features	45; 166; 7; 18; 17; 93	<0.001 sig
PRIMARY Number of Participants With Prior Joint Replacement or Surgery	31; 141; 29; 99; 21; 24	<0.001 sig
PRIMARY Number of Participants With Chest X-Ray Prior to New Therapy	183; 742	<0.001 sig
PRIMARY Number of Participants With Comorbidities	60; 488; 5; 115; 6; 73	0.381
PRIMARY Body Mass Index (BMI)	26.6; 27.2	0.188
PRIMARY Blood Pressure (BP)	134.3; 138.0; 79.4; 80.2	0.016 sig
PRIMARY Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 60	4.6; 4.4; -1.67; -1.45	<0.001 sig
PRIMARY Change From Baseline in Tender Joints Count (TJC) at Month 60	6.1; 4.8; NA; NA	<0.001 sig
PRIMARY Change From Baseline in Swollen Joints Count (SJC) at Month 60	6.0; 3.8; NA; NA	<0.001 sig
PRIMARY Change From Baseline in C-Reactive Protein (CRP) Level at Month 60	28.3; 23.1; NA; NA	0.154
PRIMARY Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 60	24.0; 26.3; NA; NA	0.108
PRIMARY Change From Baseline in Patient's Global Assessment (PtGA) of Disease Activity at Month 60	49.0; 46.7; NA; NA	0.199
PRIMARY Duration of Disease (Rheumatoid Arthritis)	14.1; 10.2	<0.001 sig
PRIMARY Time Since First Rheumatologist Visit	13.1; 9.7	<0.001 sig
PRIMARY Time Since Recalled Symptom Onset	—	—
PRIMARY Number of Participants With Previous and Current Disease Modifying Anti-Rheumatic Drugs (DMARDs)	65; 963; 7; 32; 0; 2	<0.001 sig
PRIMARY Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Month 60	1.9; 1.5; NA; NA	<0.001 sig
PRIMARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 60	27.3; 29.8; 49.1; 49.2; 49.2; 49.0	<0.001 sig
PRIMARY Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D) at Month 60	—	—
PRIMARY Time to Disease Worsening	—	—
PRIMARY Time to Therapeutic Goal	—	—
PRIMARY Change From Baseline in Pain Visual Analog Scale (VAS) Score at Month 60	—	—
PRIMARY Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 60	—	—
PRIMARY Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 60	—	—
PRIMARY Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 60	—	—
PRIMARY Number of Rheumatoid Arthritis (RA) Related Visits	—	—
PRIMARY Direct and Indirect Cost of Rheumatoid Arthritis (RA) Treatment	—	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01557322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.