Rheumatoid ArthritisEARLY RANCT01558089
Good EULAR Response In Patients With Early Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Pfizer at 9 sites in Greece.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- etanercept and methotrexate
- How many people
- 76 participants
- Where
- 9 sitesGreece
- Study dates
- Mar 2013to May 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with rheumatoid arthritis who fulfill the inclusion/exclusion criteria
Who may be able to join
- signed and dated informed consent document
- 18 years of age and older at the time of consent
- Patients with moderate-to-severe active rheumatoid arthritis, who satisfy the 2010 Rheumatoid Arthritis Classification Criteria
- 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,
- Patients with DAS28 ≥ 3.2
- Duration of disease symptoms ≥ 6 weeks and ≤2 years
- Failure to respond to prior DMARDs including MTX monotherapy according to routine clinical practice.
Who cannot join
- Contraindications according to the SmPC
- History of or present anti-TNFa or other biologic therapy for the treatment of RA
- Known significant concurrent medical disease according to investigator's opinion and the current SmPC
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Greece9 sites
G. Gennimatas General Hospital /Rheumatology Clinic
Athens, Attica, 11527
Ippokrateio General Hospital of Athens / 2nd internal Medicine Clinic of the University of Athens
Athens, Attica, 11527
Laiko General Peripheral Hospital
Athens, 115 27
University General Hospital of Heraklion
Heraklion, Creete, 71110
Peripheral University General Hospital of Larissa
Larissa, 41 222
"Olympion therapeutic center" General Clinic of Patras
Pátrai, 26443
G. Papanikolaoy
Thessaloniki, Exochi, 570 10
424 Military Hospital
Thessaloniki, Thessalonikis
Euromedica Kyanous Stavros
Thessaloniki, Thessaloniki, 54636
About this study
Official title: 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
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
Read the 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
- Conditions
- Rheumatoid Arthritis
- Being tested
- etanercept, methotrexate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etanerceptDrug
according to SmPC and clinical practice
methotrexateDrug
according to SmPC and clinical practice
| Study group | Role | What they receive |
|---|---|---|
| etanercept + methotrexate | Not described Receives: Drug: etanercept; Drug: methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Visit 4 (Month 6)
Secondary outcomes (7)
Change From Baseline in Tender Joint Count at 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.
Measured: Baseline and Visit 4 (Month 6)
Change From Baseline in Swollen Joint Count at 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.
Measured: Baseline and Visit 4 (Month 6)
Change From Baseline in Patient's Assessment of General Health (VAS) at 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)
Measured: Baseline and Visit 4 (Month 6)
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Visit 4 (Month 6)
Measured: Baseline and Visit 4 (Month 6)
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.
Measured: Baseline and Visit 4 (Month 6)
Change From Baseline in HAQ-DI at 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.
Measured: Baseline and Visit 4 (Month 6)
Predictor of Good EULAR Response Versus Moderate/No Response at Visit 4 (Month 6) - DAS28 (LOCF)
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.
Measured: Baseline and Visit 4 (Month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startMar 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558089
- Sponsor's protocol ID
- B1801138
- Acronym
- EARLY RA
- Status last verified
- Sep 2016
- First submitted
- 15 Feb 2012
- Last updated
- 11 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01558089
- Acronym / sponsor ID
- EARLY RA / B1801138
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 20 Mar 2012 (estimated)
- Results
- Posted 11 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| etanercept + methotrexate | – | Drug: etanercept, Drug: methotrexate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with rheumatoid arthritis who fulfill the inclusion/exclusion criteria
Key inclusion criteria (7 listed)
- signed and dated informed consent document
- 18 years of age and older at the time of consent
- Patients with moderate-to-severe active rheumatoid arthritis, who satisfy the 2010 Rheumatoid Arthritis Classification Criteria
- 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,
- Patients with DAS28 ≥ 3.2
Key exclusion criteria (3 listed)
- Contraindications according to the SmPC
- History of or present anti-TNFa or other biologic therapy for the treatment of RA
- Known significant concurrent medical disease according to investigator's opinion and the current SmPC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| etanerceptaccording to SmPC and clinical practice | Drug | etanercept + methotrexate |
| methotrexateaccording to SmPC and clinical practice | Drug | etanercept + methotrexate |
Primary outcome
Primary: Participants With EULAR (Good)
Time frame: 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
7 secondary outcomes
Change From Baseline in Tender Joint Count at Visit 4 (Month 6)
Time frame: Baseline and Visit 4 (Month 6)
Change From Baseline in Swollen Joint Count at Visit 4 (Month 6)
Time frame: Baseline and Visit 4 (Month 6)
Change From Baseline in Patient's Assessment of General Health (VAS) at Visit 4 (Month 6)
Time frame: Baseline and Visit 4 (Month 6)
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Visit 4 (Month 6)
Time frame: Baseline and Visit 4 (Month 6)
Change From Baseline in EQ-5D Health Index at Visit 4 (Month 6)
Time frame: Baseline and Visit 4 (Month 6)
Change From Baseline in HAQ-DI at Visit 4 (Month 6)
Time frame: Baseline and Visit 4 (Month 6)
Predictor of Good EULAR Response Versus Moderate/No Response at Visit 4 (Month 6) - DAS28 (LOCF)
Time frame: Baseline and Visit 4 (Month 6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Pfizer at 9 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary: Participants With EULAR (Good) (time frame: Visit 4 (Month 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2016.