Arthritis, PsoriaticPROVENCT00938015

Study Evaluating Safety and Adherence to Treatment With Etanercept in Adults With Psoriatic Arthritis

An observational study of Arthritis, Psoriatic, run by Pfizer at 1 site in Belgium.

Completed

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

Trial summary

The aim of this study is to evaluate if the data obtained in controlled clinical trials are confirmed when Enbrel is used in usual clinical practice in Belgium according to local reimbursement criteria. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Arthritis, Psoriatic
What is being tested?: Questionnaire
How many people: 303 participants
Where: 1 siteBelgium
Study dates: Oct 2004to Apr 2012
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: rheumatology centers

Who may be able to join

Active erosive psoriatic arthritis of poly-articular type or active erosive or with joint space narrowing psoriatic arthritis of oligo-articular type
At least 18 years old
Have fulfilled reimbursement criteria for Enbrel in psoriatic arthritis of poly-articular type or oligo-articular type
Physician decides to prescribe Enbrel or patient is already on Enbrel
Give written informed consent at time of inclusion to study

Who cannot join

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Pfizer Investigational Site
Leuven, 3000

Other trials in Belgium

About this study

Official title: A Post-Marketing Surveillance For Safety And Adherence To Treatment Of Enbrel In Adults With Psoriatic Arthritis In Belgium

Conditions: Arthritis, Psoriatic
Being tested: Questionnaire
Keywords: postmarketing surveillance, Enbrel, psoriatic arthritis
Medical subject headings: Arthritis, Psoriatic

What participants receive

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

QuestionnaireOther
This is a non-interventional study
QuestionnaireOther
This is a non-interventional study

Study groups in NCT00938015
Study group	Role	What they receive
PsA Patients (New)		New patients Receives: Other: Questionnaire
PsA Patients		CU patients Receives: Other: Questionnaire

What is being measured

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

Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Baseline up to Year 1
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 1 up to Year 2
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Year 1 up to Year 2
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 2 up to Year 3
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Year 2 up to Year 3
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 3 up to Year 4
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Year 3 up to Year 4
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 4 up to Year 5
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Year 4 up to Year 5
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 5 up to Year 6
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Year 5 up to Year 6

Secondary outcomes (7)

Percentage of Participants With at Least 1 Adverse Event (AE) Per Year
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Measured: Baseline up to Year 6
Incidence of Adverse Events and Serious Adverse Events Per Participant-Year
Participant-Year estimated by calculating all of the years that participants in a study were followed (mean study drug exposure duration multiplied by safety set population). Incidence calculated as AEs or SAEs divided by Participant-Year multiplied by 100. Incidence of AEs and SAEs were broken down by each follow-up time period.
Measured: Baseline up to Month 6, 12, 18, 30, 42, 54, 66
Percentage of Participants With Psoriatic Arthritis (PsA) Receiving Enbrel Who Stayed on the Treatment
Measured: Baseline up to Month 78
Number of Joints With Active Arthritis
Numbers of joints with active arthritis were defined as joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness.
Measured: Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78
Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Participant Evaluation
Quality of life for oligo-articular type arthritis was assessed on a 11-point Numerical Rating Scale (NRS) ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per participant was evaluated.
Measured: Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78
Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Physician Evaluation
Quality of life for oligo-articular type arthritis was assessed on a 11-point NRS ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per physician was evaluated.
Measured: Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78
Quality of Life Assessed by Health Assessment Questionnaire (HAQ) For Poly-Articular Type Psoriatic Arthritis (PsA)
HAQ is a 20 item questionnaire to measure functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 items grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. Total score range 0-60, higher score indicating greater functional limitations.
Measured: Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78

Timeline

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

Oct 2004Apr 2012

First posted13 Jul 2009 (estimated)
Study startOct 2004
Primary completionApr 2012
Study completionApr 2012

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Arthritis, PsoriaticStudies 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: Retrospective
Enrolment: 303 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00938015
Sponsor's protocol ID: 0881A-101698
Other IDs: B1801107
Acronym: PROVE
Status last verified: Mar 2013
First submitted: 10 Jul 2009
Last updated: 27 May 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

de Vlam K, Boone C, The Prove Study Group A. Treatment adherence, efficacy, and safety of etanercept in patients with active psoriatic arthritis and peripheral involvement in Belgium for 66 months (PROVE study). Clin Exp Rheumatol. 2015 Sep-Oct;33(5):624-31. Epub 2015 Jul 23.
PubMed 26212872

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

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Psoriatic Arthritis (PsA)
Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Psoriatic Arthritis

All Arthritis, Psoriatic trials

Study at a glance

From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post-Marketing Surveillance For Safety And Adherence To Treatment Of Enbrel In Adults With Psoriatic Arthritis In Belgium
ClinicalTrials.gov ID: NCT00938015
Acronym / sponsor ID: PROVE / 0881A-101698
Conditions: Arthritis, Psoriatic
Keywords: postmarketing surveillance, Enbrel, psoriatic arthritis
Study type: Observational
Recruitment status: Completed
Enrolment: 303 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Oct 2004
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 13 Jul 2009 (estimated)
Results: Posted 27 May 2013

Clinical summary

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

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
PsA Patients (New)	–	Other: QuestionnaireNew patients
PsA Patients	–	Other: QuestionnaireCU patients

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: rheumatology centers

Key inclusion criteria (5 listed)

Active erosive psoriatic arthritis of poly-articular type or active erosive or with joint space narrowing psoriatic arthritis of oligo-articular type
At least 18 years old
Have fulfilled reimbursement criteria for Enbrel in psoriatic arthritis of poly-articular type or oligo-articular type
Physician decides to prescribe Enbrel or patient is already on Enbrel
Give written informed consent at time of inclusion to study

Key exclusion criteria (1 listed)

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
QuestionnaireThis is a non-interventional study	Other	PsA Patients (New)
QuestionnaireThis is a non-interventional study	Other	PsA Patients

Primary outcome

Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1
Time frame: Baseline up to Year 1
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 1 up to Year 2
Time frame: Year 1 up to Year 2
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 2 up to Year 3
Time frame: Year 2 up to Year 3
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 3 up to Year 4
Time frame: Year 3 up to Year 4
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 4 up to Year 5
Time frame: Year 4 up to Year 5
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 5 up to Year 6
Time frame: Year 5 up to Year 6
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

7 secondary outcomes

Percentage of Participants With at Least 1 Adverse Event (AE) Per Year
Time frame: Baseline up to Year 6
Incidence of Adverse Events and Serious Adverse Events Per Participant-Year
Time frame: Baseline up to Month 6, 12, 18, 30, 42, 54, 66
Percentage of Participants With Psoriatic Arthritis (PsA) Receiving Enbrel Who Stayed on the Treatment
Time frame: Baseline up to Month 78
Number of Joints With Active Arthritis
Time frame: Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78
Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Participant Evaluation
Time frame: Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78
Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Physician Evaluation
Time frame: Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78
Quality of Life Assessed by Health Assessment Questionnaire (HAQ) For Poly-Articular Type Psoriatic Arthritis (PsA)
Time frame: Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78

Results and safety

Results posted to the registry on 27 May 2013, 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	303	156

Primary outcome: Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1

Time frame: Baseline up to Year 1. Number. Unit: Percentage of participants

Measure	Etanercept n = 301
Value	7.97

Population analysed: Safety set included all the participants who signed informed consent form (ICF) and had at least one dose of study medication and had follow-up data.

Primary outcome: Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 1 up to Year 2

Time frame: Year 1 up to Year 2. Number. Unit: Percentage of participants

Measure	Etanercept n = 278
Value	7.91

Population analysed: Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Primary outcome: Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 2 up to Year 3

Time frame: Year 2 up to Year 3. Number. Unit: Percentage of participants

Measure	Etanercept n = 227
Value	4.85

Primary outcome: Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 3 up to Year 4

Time frame: Year 3 up to Year 4. Number. Unit: Percentage of participants

Measure	Etanercept n = 198
Value	4.55

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etanercept	65 of 301 (21.6%)	179 of 301 (59.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26212872de Vlam K, Boone C, The Prove Study Group A. Treatment adherence, efficacy, and safety of etanercept in patients with active psoriatic arthritis and peripheral involvement in Belgium for 66 months (PROVE study). Clin Exp Rheumatol. 2015 Sep-Oct;33(5):624-31. Epub 2015 Jul 23.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Arthritis, Psoriatic

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Psoriatic Arthritis (PsA)
Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Psoriatic Arthritis

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Arthritis, Psoriatic, run by Pfizer at 1 site in Belgium.

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 5 inclusion and 1 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 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. 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 27 May 2013). 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 at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1 (time frame: Baseline up to Year 1). The study lists 6 primary outcomes in all. 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 NCT00938015, which also lists 1 linked publication.

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 27 May 2013.