Good EULAR Response In Patients With Early Rheumatoid Arthritis

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: etanercept; Drug: methotrexate

• Registration Number: NCT01558089
• Lead Sponsor: Pfizer

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

Study Timeline

• Study First Submitted: 2012-02-15
• Study First Submitted QC: 2012-03-19
• Study First Posted: 2012-03-20
• Study Start: 2013-03
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2016-05-25
• Status Verified: 2016-09
• Results First Submitted QC: 2016-09-21
• Last Update Submitted: 2016-09-21
• Results First Posted: 2016-11-11
• Last Update Posted: 2016-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
etanercept + methotrexate	etanercept	-
etanercept + methotrexate	methotrexate	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.
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.

Trial Locations

Locations (9)

G. Papanikolaoy; 🇬🇷 Thessaloniki, Exochi, Greece

"Olympion therapeutic center" General Clinic of Patras; 🇬🇷 Patras, Greece

424 Military Hospital; 🇬🇷 Thessaloniki, Thessalonikis, Greece

G. Gennimatas General Hospital /Rheumatology Clinic; 🇬🇷 Athens, Attica, Greece

Euromedica Kyanous Stavros; 🇬🇷 Thessaloniki, Greece

Ippokrateio General Hospital of Athens / 2nd internal Medicine Clinic of the University of Athens; 🇬🇷 Athens, Attica, Greece

Laiko General Peripheral Hospital; 🇬🇷 Athens, Greece

University General Hospital of Heraklion; 🇬🇷 Heraklion, Creete, Greece

Peripheral University General Hospital of Larissa; 🇬🇷 Larissa, Greece