Trial Outcomes & Findings for Good EULAR Response In Patients With Early Rheumatoid Arthritis (NCT NCT01558089)
NCT ID: NCT01558089
Last Updated: 2016-11-11
Results Overview
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
COMPLETED
76 participants
Visit 4 (Month 6)
2016-11-11
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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76
|
|
Overall Study
COMPLETED
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63
|
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Overall Study
NOT COMPLETED
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13
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Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Adverse Event
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1
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|
Overall Study
Lack of Efficacy
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1
|
|
Overall Study
Lost to Follow-up
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5
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|
Overall Study
Withdrawal by Subject
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6
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Baseline Characteristics
Good EULAR Response In Patients With Early Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
ETANERCEPT/ METHOTREXATE
n=76 Participants
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.
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|---|---|
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Age, Continuous
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55.5 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
|
Sex: Female, Male
Female
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66 Participants
n=5 Participants
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Sex: Female, Male
Male
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10 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
Etanercept/Methotrexate
n=48 Participants
All participants in this study who received Etanercept and Methotrexate
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|---|---|
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Primary: Participants With EULAR (Good)
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19 participants
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SECONDARY outcome
Timeframe: Baseline and Visit 4 (Month 6)Population: The analysis was based on the Full Analysis Set (FAS) population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.
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.
Outcome measures
| Measure |
Etanercept/Methotrexate
n=63 Participants
All participants in this study who received Etanercept and Methotrexate
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|---|---|
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Change From Baseline in Tender Joint Count at Visit 4 (Month 6)
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-7.68 Joints
Standard Deviation 7.08
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SECONDARY outcome
Timeframe: Baseline and Visit 4 (Month 6)Population: The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.
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.
Outcome measures
| Measure |
Etanercept/Methotrexate
n=63 Participants
All participants in this study who received Etanercept and Methotrexate
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|---|---|
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Change From Baseline in Swollen Joint Count at Visit 4 (Month 6)
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-4.52 Joints
Standard Deviation 5.22
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SECONDARY outcome
Timeframe: Baseline and Visit 4 (Month 6)Population: The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.
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)
Outcome measures
| Measure |
Etanercept/Methotrexate
n=44 Participants
All participants in this study who received Etanercept and Methotrexate
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|---|---|
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Change From Baseline in Patient's Assessment of General Health (VAS) at Visit 4 (Month 6)
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-38.14 mm
Standard Deviation 28.79
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SECONDARY outcome
Timeframe: Baseline and Visit 4 (Month 6)Population: The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.
Outcome measures
| Measure |
Etanercept/Methotrexate
n=38 Participants
All participants in this study who received Etanercept and Methotrexate
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|---|---|
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Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Visit 4 (Month 6)
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-21.21 mm/hour
Standard Deviation 22.28
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SECONDARY outcome
Timeframe: Baseline and Visit 4 (Month 6)Population: The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.
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.
Outcome measures
| Measure |
Etanercept/Methotrexate
n=49 Participants
All participants in this study who received Etanercept and Methotrexate
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|---|---|
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Change From Baseline in EQ-5D Health Index at Visit 4 (Month 6)
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0.40 units on scale
Standard Deviation 0.36
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SECONDARY outcome
Timeframe: Baseline and Visit 4 (Month 6)Population: The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.
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.
Outcome measures
| Measure |
Etanercept/Methotrexate
n=52 Participants
All participants in this study who received Etanercept and Methotrexate
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|---|---|
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Change From Baseline in HAQ-DI at Visit 4 (Month 6)
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-0.78 units on scale
Standard Deviation 0.63
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SECONDARY outcome
Timeframe: Baseline and Visit 4 (Month 6)Population: The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.
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.
Outcome measures
| Measure |
Etanercept/Methotrexate
n=48 Participants
All participants in this study who received Etanercept and Methotrexate
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|---|---|
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Predictor of Good EULAR Response Versus Moderate/No Response at Visit 4 (Month 6) - DAS28 (LOCF)
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2.831 Odds Ratio (per unit increase)
Interval 1.358 to 5.898
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Adverse Events
ETANERCEPT/ METHOTREXATE
Serious adverse events
| Measure |
ETANERCEPT/ METHOTREXATE
n=76 participants at risk
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.
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|---|---|
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Eye disorders
Ulcerative keratitis
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1.3%
1/76
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General disorders
Injection site pruritus
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1.3%
1/76
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Hepatobiliary disorders
Gallbladder disorder
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1.3%
1/76
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Infections and infestations
Gastroenteritis
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1.3%
1/76
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Infections and infestations
Lower respiratory tract infection
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1.3%
1/76
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Infections and infestations
Respiratory tract infection
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1.3%
1/76
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Musculoskeletal and connective tissue disorders
Myopathy
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1.3%
1/76
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Nervous system disorders
Headache
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1.3%
1/76
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|
Vascular disorders
Thrombosis
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1.3%
1/76
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Other adverse events
| Measure |
ETANERCEPT/ METHOTREXATE
n=76 participants at risk
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.
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|---|---|
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Ear and labyrinth disorders
Vertigo
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2.6%
2/76
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Gastrointestinal disorders
Diarrhoea
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2.6%
2/76
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|
General disorders
Drug ineffective
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2.6%
2/76
|
|
General disorders
Injection site erythema
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2.6%
2/76
|
|
General disorders
Injection site pruritus
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2.6%
2/76
|
|
Musculoskeletal and connective tissue disorders
Arthritis
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2.6%
2/76
|
|
Skin and subcutaneous tissue disorders
Alopecia
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2.6%
2/76
|
|
Skin and subcutaneous tissue disorders
Erythema
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3.9%
3/76
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER