Good EULAR Response In Patients With Early Rheumatoid Arthritis

Ability To Achieve A Good Eular Response In Patients With Moderate-to-severe Active Early Rheumatoid Arthritis Who Satisfy The New Acr/Eular Classification Criteria Receiving Etanercept + Mtx In Real World Clinical Practice In Greece

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01558089

Acronym

EARLY RA

Enrollment

Registered

2012-03-20

Start date

2013-03-31

Completion date

2015-05-31

Last updated

2016-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

This open-label, prospective, observational study will evaluate the clinical response to etanercept + methotrexate therapy in patients with moderate to severe rheumatoid arthritis, as prescribed by the rheumatologist in a normal clinical setting in Greece

Detailed description

All subjects enrolled should meet the usual prescribing criteria for Etanercept as per the local product information and should be entered into the study at the investigator's discretion

Interventions

DRUGetanercept

according to SmPC and clinical practice

DRUGmethotrexate

according to SmPC and clinical practice

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. signed and dated informed consent document 2. 18 years of age and older at the time of consent 3. Patients with moderate-to-severe active rheumatoid arthritis, who satisfy the 2010 Rheumatoid Arthritis Classification Criteria 4. Patients who have been prescribed for first time to receive treatment with MTX + Etanercept prior to enrollment to this study, following routine clinical practice and according to the approved SmPC, 5. Patients with DAS28 ≥ 3.2 6. Duration of disease symptoms ≥ 6 weeks and ≤2 years 7. Failure to respond to prior DMARDs including MTX monotherapy according to routine clinical practice.

Exclusion criteria

1. Contraindications according to the SmPC 2. History of or present anti-TNFa or other biologic therapy for the treatment of RA 3. Known significant concurrent medical disease according to investigator's opinion and the current SmPC

Design outcomes

Primary

Measure	Time frame	Description
Primary: Participants With EULAR (Good)	Visit 4 (Month 6)	Good European League Against Rheumatism (EULAR) response at 6 months based on DAS28 EULAR response criteria defined as Good response = DAS28 change \>1.2 with DAS28 ≤3.2; Moderate response = DAS28 change \>0.6 with DAS28 \>3.2-5.1; Non-response = DAS28 change ≤0.6 and absolute DAS28 \>5.1

Secondary

Measure	Time frame	Description
Change From Baseline in Swollen Joint Count at Visit 4 (Month 6)	Baseline and Visit 4 (Month 6)	In order to calculate the DAS28 the number of swollen joints and tender joints were assessed using the 28 Joint Count (TJC28 and SJC28). A joint was counted as tender/swollen if the tender/swelling code was 'Present'. Swollen and tender 28 joint counts will be performed at visit 1 (baseline), visit 2, visit 3 and visit 4 or early withdrawal.
Change From Baseline in Patient's Assessment of General Health (VAS) at Visit 4 (Month 6)	Baseline and Visit 4 (Month 6)	The patients used a 100 mm Visual Analogue Scale (VAS) to score their general health during the last week. The scale ranged from 0 (no pain) to 100 mm (severe pain)
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Visit 4 (Month 6)	Baseline and Visit 4 (Month 6)	—
Change From Baseline in Tender Joint Count at Visit 4 (Month 6)	Baseline and Visit 4 (Month 6)	In order to calculate the DAS28 the number of swollen joints and tender joints were assessed using the 28 Joint Count (TJC28 and SJC28). A joint was counted as tender/swollen if the tender/swelling code was 'Present'. Swollen and tender 28 joint counts will be performed at visit 1 (baseline), visit 2, visit 3 and visit 4 or early withdrawal.
Change From Baseline in HAQ-DI at Visit 4 (Month 6)	Baseline and Visit 4 (Month 6)	The Health Assessment Questionnaire-Disability Index (HAQ-DI) is composed of 20 items. It is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score ranges from 0-3: 0=least difficulty and 3=extreme difficulty.
Predictor of Good EULAR Response Versus Moderate/No Response at Visit 4 (Month 6) - DAS28 (LOCF)	Baseline and Visit 4 (Month 6)	In a first step a univariate logistic regression model was fit for the following baseline variables: DAS28 (n=48), Physician's Global Assessment of Disease Activity (VAS) (n=47), Patient's Global Assessment of Disease Activity (VAS) (n=47), CRP (n=46), Patient Pain (VAS) (n=47), HAQ-DI (n=47), EQ-5D (n=47). Only those variables that were significant at a 10% level were then included in the second step: a multivariate analysis with stepwise regression (entry level=10%, stay level=5%). The final model presented in the Basic Results table displays those covariates which were significant at the 2-sided 5% level (baseline value for DAS28; n=48). Note that DAS28 is not a categorical variable; therefore no stratified results for this variable are presented.
Change From Baseline in EQ-5D Health Index at Visit 4 (Month 6)	Baseline and Visit 4 (Month 6)	The European Quality of Life-5 Dimensions (EQ-5D) was measured on a 5 item scale. The scores for the 5 items (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) ranged from 1 (no problem) to 3 (extreme problems). For EQ-5D, participants rate questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each of the 5 dimensions is divided into 3 levels of perceived problems: Level 1=no problem; level 2=some problem; level 3=extreme problem. A unique health state is defined by combining 1 level from each dimension. A total of 243 possible health states are defined in this way. Each state is referred to in terms of a 5 digit code. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Countries

Greece

Participant flow

Participants by arm

Arm	Count
ETANERCEPT/ METHOTREXATE The study group comprised adult patients who at the time of entry had moderate-to-severe rheumatoid arthritis (RΑ), having symptoms for at least 6 weeks and no more than 2 years while satisfying the 2010 RA classification criteria, Disease Activity Score 28 (DAS28) ≥3.2, and who were prescribed for the first time to receive Methotrexate + Etanercept according to routine clinical practice and current summary of product characteristics, prior to enrollment in this study.	76
Total	76

Arm

Count

ETANERCEPT/ METHOTREXATE

The study group comprised adult patients who at the time of entry had moderate-to-severe rheumatoid arthritis (RΑ), having symptoms for at least 6 weeks and no more than 2 years while satisfying the 2010 RA classification criteria, Disease Activity Score 28 (DAS28) ≥3.2, and who were prescribed for the first time to receive Methotrexate + Etanercept according to routine clinical practice and current summary of product characteristics, prior to enrollment in this study.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	1
Overall Study	Lack of Efficacy	1
Overall Study	Lost to Follow-up	5
Overall Study	Withdrawal by Subject	6

Baseline characteristics

Characteristic	ETANERCEPT/ METHOTREXATE
Age, Continuous	55.5 years STANDARD_DEVIATION 14.3
Sex: Female, Male Female	66 Participants
Sex: Female, Male Male	10 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	14 / 76
serious Total, serious adverse events	6 / 76

Outcome results

Primary

Primary: Participants With EULAR (Good)

Good European League Against Rheumatism (EULAR) response at 6 months based on DAS28 EULAR response criteria defined as Good response = DAS28 change \>1.2 with DAS28 ≤3.2; Moderate response = DAS28 change \>0.6 with DAS28 \>3.2-5.1; Non-response = DAS28 change ≤0.6 and absolute DAS28 \>5.1

Time frame: Visit 4 (Month 6)

Population: Last observation carried forward (LOCF) was applied where data were available. Participants where a EULAR response value could not be calculated, were omitted from the analysis. Only 48 Participants had available EULAR response data at 6 months.

Arm	Measure	Value (NUMBER)
Etanercept/Methotrexate	Primary: Participants With EULAR (Good)	19 participants

Secondary

Change From Baseline in EQ-5D Health Index at Visit 4 (Month 6)

The European Quality of Life-5 Dimensions (EQ-5D) was measured on a 5 item scale. The scores for the 5 items (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) ranged from 1 (no problem) to 3 (extreme problems). For EQ-5D, participants rate questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each of the 5 dimensions is divided into 3 levels of perceived problems: Level 1=no problem; level 2=some problem; level 3=extreme problem. A unique health state is defined by combining 1 level from each dimension. A total of 243 possible health states are defined in this way. Each state is referred to in terms of a 5 digit code. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.