Study to Observe the Safety and Efficacy of Etanercept (Enbrel®) in Patients With Moderately Active Rheumatoid Arthritis in Every Day Clinical Practice in Austria

An observational study of Rheumatoid Arthritis, run by Pfizer at 10 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a prospective non-interventional observational study to evaluate the treatment of moderately active RA patients in every day clinical practice in Austria. Patients will be observed over 52 weeks. The primary endpoint will be percentage of patients who reach CDAI remission after 24 weeks. 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?: non-intervention
How many people: 111 participants
Where: 10 sitesAustria
Study dates: 10 Dec 2012to 14 Jun 2016
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 moderately active RA that are treated with Etanercept will be studied. All patients enrolled should meet the usual prescribing criteria for Etanercept as per the Austrian SmPC and should be entered into the study at the investigator's discretion.

Who may be able to join

The patient is eligible to receive Etanercept treatment according to the Austrian SmPC.
The decision to treat the patient with Etanercept has been made independently by the physician and is clearly separated from the decision to include the patient in the study. The treatment decision was made in advance and is not dependent on the protocol.
The patient was informed about the study and gave his/her consent and signed an Independent Ethics Committee (IEC) submitted written Informed Consent form on use of the data.
The patient has moderately active RA, defined as a disease activity of CDAI >10 and ≤22 and/or DAS28 (CRP)>3.2 and ≤ 5.1

Who cannot join

Any contraindication according to the Austrian SmPC, which includes:
A hypersensitivity to any component of Etanercept, active tuberculosis or any other serious infection.
Patient has previously participated in this study.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Austria10 sites

Ordination Dr. Thomas Muller
Graz, 8010
Barmherzige Brüder Graz Eggenberg
Graz, 8020
Ordination Dr. Horst Just
Klagenfurt, 9020
Ordination Dr. Richard Janetschko
Linz, 4020
Ordination Dr. Wilhelm Kaiser
Linz, 4030
Dr. Eichbauer-Sturm
Linz, 4040
Rheumazentrum Oberlaa
Vienna, 1100
Ordination Dr. Peter Peichl
Vienna, 1130
Ordination Dr. Maya Thun
Vienna, 1170
Ordination Dr. Thomas Schwingenschlogl
Wiener Neudorf, 2351

Other trials in Austria

About this study

Official title: A Multicenter Non-interventional Study To Observe The Safety And Efficacy Of Etanercept (Enbrel (Registered)) In Patients With Moderately Active Rheumatoid Arthritis In Every Day Clinical Practice In Austria

Read the detailed description

Non-interventional observational study, national, multicenter prospective non-interventional study (NIS) as defined by the Austrian Drug Law § 2a Section 3 N/A

Conditions: Rheumatoid Arthritis
Being tested: non-intervention
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

non-interventionOther
observation of Etanercept treatment in moderately active RA patients in Austria. Etanercept treatment according to Austrian SmPC

Study groups in NCT01877239
Study group	Role	What they receive
Full Analysis Set		Full Analysis Set (FAS): The FAS contains any patient that has given written informed consent. Receives: Other: non-intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24
CDAI is a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment), PtGA and PGA (assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0-76. CDAI less than equal to (<=) 2.8 indicates disease remission, greater than (>) 2.8 to 10 = low disease activity, greater than (>) 10 to 22 = moderate disease activity, and >22 = high disease activity. Percentage of participants with CDAI remission (score <=2.8) at Week 24 were reported.
Measured: Week 24

Secondary outcomes (2)

Percentage of Participants With Clinical Disease Activity Index (CDAI) Status of Disease Activity at Week 12 and Week 52
CDAI is a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC, TJC (based on 28-joint assessment), PtGA and PGA (assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, > 2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity. Percentage of participants with different type of CDAI status of disease activity (remission, low disease, moderate and high disease activity) at Week 12 and 52 were reported. Only those categories in which at least 1 participant had data were reported.
Measured: Week 12 and Week 52
Change From Baseline in Clinical Disease Activity Index (CDAI) Scores at Week 12, Week 24 and Week 52
CDAI is a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC, TJC (based on 28-joint assessment), PtGA and PGA (assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, > 2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.
Measured: Baseline, Week 12, Week 24, Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Dec 201214 Jun 2016

First posted13 Jun 2013 (estimated)
Study start10 Dec 2012
Primary completion7 Jan 2016
Study completion14 Jun 2016

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: Other
Time perspective: Prospective
Enrolment: 111 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01877239
Sponsor's protocol ID: B1801357
Status last verified: Apr 2018
First submitted: 11 Jun 2013
Last updated: 3 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of PTC844 in Participants With Active Rheumatoid Arthritis
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An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
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Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
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RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
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Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Non-interventional Study To Observe The Safety And Efficacy Of Etanercept (Enbrel (Registered)) In Patients With Moderately Active Rheumatoid Arthritis In Every Day Clinical Practice In Austria
ClinicalTrials.gov ID: NCT01877239
Acronym / sponsor ID: B1801357
Conditions: Rheumatoid Arthritis
Study type: Observational
Recruitment status: Completed
Enrolment: 111 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 10 Dec 2012 (actual)
Primary completion: 7 Jan 2016 (actual)
Study completion: 14 Jun 2016 (actual)
First posted: 13 Jun 2013 (estimated)
Results: Posted 3 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Non-interventional observational study, national, multicenter prospective non-interventional study (NIS) as defined by the Austrian Drug Law § 2a Section 3 N/A

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Full Analysis Set	–	Other: non-interventionFull Analysis Set (FAS): The FAS contains any patient that has given written informed consent.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with moderately active RA that are treated with Etanercept will be studied. All patients enrolled should meet the usual prescribing criteria for Etanercept as per the Austrian SmPC and should be entered into the study at the investigator's discretion.

Key inclusion criteria (4 listed)

The patient is eligible to receive Etanercept treatment according to the Austrian SmPC.
The decision to treat the patient with Etanercept has been made independently by the physician and is clearly separated from the decision to include the patient in the study. The treatment decision was made in advance and is not dependent on the protocol.
The patient was informed about the study and gave his/her consent and signed an Independent Ethics Committee (IEC) submitted written Informed Consent form on use of the data.
The patient has moderately active RA, defined as a disease activity of CDAI >10 and ≤22 and/or DAS28 (CRP)>3.2 and ≤ 5.1

Key exclusion criteria (3 listed)

Any contraindication according to the Austrian SmPC, which includes:
A hypersensitivity to any component of Etanercept, active tuberculosis or any other serious infection.
Patient has previously participated in this study.

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
non-interventionobservation of Etanercept treatment in moderately active RA patients in Austria. Etanercept treatment according to Austrian SmPC	Other	Full Analysis Set

Primary outcome

Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24
Time frame: Week 24
CDAI is a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment), PtGA and PGA (assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0-76. CDAI less than equal to (<=) 2.8 indicates disease remission, greater than (>) 2.8 to 10 = low disease activity, greater than (>) 10 to 22 = moderate disease activity, and >22 = high disease activity. Percentage of participants with CDAI remission (score <=2.8) at Week 24 were reported.

2 secondary outcomes

Percentage of Participants With Clinical Disease Activity Index (CDAI) Status of Disease Activity at Week 12 and Week 52
Time frame: Week 12 and Week 52
Change From Baseline in Clinical Disease Activity Index (CDAI) Scores at Week 12, Week 24 and Week 52
Time frame: Baseline, Week 12, Week 24, Week 52

Results and safety

Results posted to the registry on 3 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Etanercept	111	61

Primary outcome: Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24

Time frame: Week 24. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Etanercept n = 61
Value	44.3 (31.53 to 57.56)

Population analysed: Eligible Set included all participants who had given written informed consent and had received at least one dose of etanercept with evaluable CDAI assessments at baseline and Week 24.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Week 52. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etanercept	8 of 76 (10.5%)	16 of 76 (21.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
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.

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

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

10 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 10 sites in Austria.

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 4 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 3 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Austria. 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 3 Dec 2018). 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?

Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01877239.

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 3 Dec 2018.