Prospective Evaluation of the Radiographic Efficacy of Enbrel

An observational study of Rheumatoid Arthritis and Psoriasis Arthritis, run by Pfizer.

Completed

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

Trial summary

It is known from the COMET-trial that patients who start Enbrel treatment early have a great chance of reaching clinical remission and radiographic nonprogression. It is still unclear, however, how many patients with early arthritis achieve remission and radiographic nonprogression under the conditions of routine… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis, Psoriasis Arthritis
What is being tested?: Etanercept
How many people: 1,821 participants
Where: No sites listed yet
Study dates: Feb 2012to Mar 2018
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: Only patients for whom the decision has already been made to initiate treatment with Enbrel® can be enrolled in this observational trial. These patients must have a proven diagnosis of Rheumatoid Arthritis or Psoriasis Arthritis

Who may be able to join

Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator's study team before subjects are included in the study.
Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study is a requirement for inclusion into this study.
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Definitive diagnosis of RA or PsA.
Eligible for Etanercept treatment according to Summary of Product Characteristics (SmPC).
Inclusion of subjects pretreated with other biologics other than Etanercept is possible
One plain radiograph of hands and feet (Anteroposterior) within 3 month prior to initiation of treatment with Etanercept and one planned consecutive radiograph of hand and feet taken over 12 to 18 months according to German recommendations for patients treated with biologics.

Who cannot join

Receipt of any investigational drug within 3 months of study inclusion.
Exclusion Criteria according to the Enbrel® SmPC, with particular attention to:
Hypersensitivity to the active substance (etanercept) or to any of the excipients.
Sepsis or risk of sepsis.
Active infections, including chronic or localised infections.
Subjects who have received any previous treatment with etanercept
Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.

About this study

Official title: A PROSPECTIVE EVALUATION OF THE RADIOGRAPHIC EFFICACY OF ETANERCEPT IN PATIENTS WITH RHEUMATOID ARTHRITIS OR PSORIATIC ARTHRITIS.

Therefore, no robust x-ray data are available to show/demonstrate

the average extent of x-ray damage in routine patients on Enbrel outside clinical studies.
if the outstanding effect on structural damage of Enbrel can be reproduced in routine practice.
that the 'Silent Progressor' is an issue relevant not only in clinical trials, but also for day-to-day decision making.
the optimal onset of Enbrel treatment in the course of the disease to prevent radiographic damage

Read the detailed description

Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Conditions: Rheumatoid Arthritis, Psoriasis Arthritis
Being tested: Etanercept
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
Also called Enbrel
The patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
EtanerceptDrug
Also called Enbrel
The patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.

Study groups in NCT01623752
Study group	Role	What they receive
Patients with Rheumatoid Arthritis		Not described Receives: Drug: Etanercept
Patients with Psoriasis Arthritis		Not described Receives: Drug: Etanercept

What is being measured

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

Change From Baseline in Van Der Heijde Total Modified Total Sharp Score (mTSS) or Adapted mTSS at End of Phase 1 (Week 78): Efficacy Analysis Set (EAS)
To assess radiological damage mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively.
Measured: Baseline, Week 78
Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 1 (Week 78): Completer Analysis Set (CAS)
To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively.
Measured: Baseline, Week 78
Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at the End of Phase 2 (Week 156): EAS
To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively.
Measured: Baseline, Week 156
Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 2 (Week 156): CAS
To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively.
Measured: Baseline, Week 156
Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): EAS
The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (greater than [>] 0.5), no change (-0.5 to 0.5) and decrease (less than [<] -0.5). Participants with no change or a decrease were considered to be in radiographic remission.
Measured: Pre-treatment, Week 78
Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): CAS
The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (>0.5), no change (-0.5 to 0.5) and decrease (<-0.5). Participants with no change or a decrease were considered to be in radiographic remission.
Measured: Pre-treatment, Week 78
Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 2 (Week 156): EAS
The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (>0.5), no change (-0.5 to 0.5) and decrease (<-0.5). Participants with no change or a decrease were considered to be in radiographic remission.
Measured: Pre-treatment, Week 156
Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at the End of Phase 2 (Week 156): CAS
The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (>0.5), no change (-0.5 to 0.5) and decrease (<-0.5). Participants with no change or a decrease were considered to be in radiographic remission.
Measured: Pre-treatment, Week 156

Secondary outcomes (24)

Linear Relationship Between Normalized Radiographic Progression and Disease Duration
Linear relationship between radiographic progression and disease duration was evaluated using a linear regression model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was disease duration.
Measured: Baseline up to Week 78
Effect on Normalized Radiographic Progression With Respect to Baseline Positivity of Anti-citrullinated Protein Antibody (ACPA) - Rheumatoid Factor (RF)
Effect on normalized radiographic progression with respect to ACPA-RF was evaluated using an analysis of variance (ANOVA) model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was groups of positive testing of ACPA and RF at baseline.
Measured: Baseline up to Week 78
Effect on Normalized Radiographic Progression With Respect to Baseline Usage of Concomitant Medication
Effect on normalized radiographic progression with respect to use of concomitant medication at baseline was evaluated using an ANOVA model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was groups of concomitant medication as found among the medication given concomitantly during study that is recorded at baseline.
Measured: Baseline up to Week 78
Effect on Normalized Radiographic Progression With Respect to Previous Treatment With Biologics
Effect on normalized radiographic progression of previous treatment with biologics was evaluated using an ANOVA model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was previous treatment with biologics.
Measured: Baseline up to Week 78
Effect on Normalized Radiographic Progression With Respect to Baseline Disease Activity Score-28 (DAS-28)
Effect on radiographic progression with respect to baseline DAS-28 was evaluated using ANOVA model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was baseline DAS-28. Baseline DAS-28 is less than or equal to (<=) 5.1 or >5.1. DAS28: score range from 0 (none) to 9.4 (extreme disease activity); low =2.6 to 3.2, moderate =3.2 to 5.1, and high disease activity >5.1. DAS28 score of <2.6 indicates disease remission.
Measured: Baseline up to Week 78
Change From Baseline in Total Erosion Score at End of Phase 1 (Week 78) and Phase 2 (Week 156)
Total erosion score as per van der Hejde method consisted of 2 dimensions: a) hands (32 erosion locations, each location graded from 0 [no erosion] to 5 [maximum severity], sum of grading of each location resulted in score of 0 to 160); and b) feet (12 erosion locations, each location graded from 0 [no erosion] to 10 [maximum severity], sum of grading of each location resulted in score of 0 to 120). Sum of erosion scores of hand (0 to 160) and feet (0 to 120) gave a total erosion score as 0 to 280, where 0 was no erosion at all and 280 was worst possible condition, higher scores indicated severe joint destruction.
Measured: Baseline, Week 78, 156
Change From Baseline in Total Joint Space Narrow Score at End of Phase 1 (Week 78) and Phase 2 (Week 156)
Total joint space narrow score as per van der Hejde method consisted of 2 dimensions: a) hands (30 joint space locations, each location graded from 0 [normal joint space] to 4 [bony ankylosis], sum of grading of each location resulted in score of 0 to 120); and b) feet (12 erosion locations, each location graded from 0 [no erosion] to 4 [bony ankylosis], sum of grading of each location resulted in score of 0 to 48). Sum of joint space narrow scores of hand (0 to 120) and feet (0 to 48) gave a total joint space narrow score as 0 to 168, where 0 was normal joint space and 168 was maximum narrowing in joints, higher scores indicated severe joint destruction.
Measured: Baseline, Week 78, 156
Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
FFbH is a self-administered patient questionnaire composed by 18 questions on functional ability in activities of daily living. Each question was answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned =2), "Yes, but with difficulties" (score assigned =1) and "No or only with external help" (score assigned =0). Final FFbH score (%) was then computed according to formula: (Sum of scores*100) divided by (2*number of valid answers), ranging between 0 (no functional capacity) to 100 (full functional capacity); higher scores indicate better daily activities. FFbH functional remission was defined as FFbH functional capacity of >= 83%.
Measured: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
DAS28 was calculated from swollen joint count and tender joint count using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PtGA) of disease activity measured on a 100 mm visual analog scale (VAS) ranging from 0 (good condition) to 100 (worst condition), where higher scores indicate worse health condition). DAS28 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity. DAS-28 score of 2.6 to 3.2= low, 3.2 to 5.1= moderate and >5.1= high disease activity. DAS-28 score of <2.6= disease remission. DAS28-4(CRP) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.36*ln[CRP+1]) + 0.014*GH + 0.96) and DAS28-4(ESR) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.70*ln[ESR] + 0.014*GH), where sqrt = square root, ln = natural logarithm.
Measured: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis
CDAI was calculated from tender and swollen joints using 28 joint count, participant global assessment (PtGA) and physician global assessment (PhyGA). PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity. CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <=10 indicates low disease activity and a score of <= 2.8 indicates remission.
Measured: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Change From Baseline in Simple Disease Activity Index (SDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis
SDAI was calculated from tender and swollen joints using 28 joint count, participant global assessment (PtGA), physician global assessment and (PhyGA) and CRP (in mg/L). PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity. SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of <=11 indicates low disease activity and a score of <=3.3 indicates remission.
Measured: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI)
CDAI was calculated from tender and swollen joints using 28 joint count, PtGA and PhyGA. CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <=10 indicates low disease activity and a score of <= 2.8 indicates remission. SDAI was calculated from tender and swollen joints using 28 joint count, PtGA, PhyGA and CRP (in mg/L). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of <=11 indicates low disease activity and a score of <=3.3 indicates remission. PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity.
Measured: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI)
CDAI was calculated from tender and swollen joints using 28 joint count, PtGA and PhyGA. CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <=10 indicates low disease activity and a score of <= 2.8 indicates remission. SDAI was calculated from tender and swollen joints using 28 joint count, PtGA, PhyGA and CRP (in mg/L). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of <=11 indicates low disease activity and a score of <=3.3 indicates remission. PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity.
Measured: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
VAS: participants placed a mark indicating the intensity of their pain on a scale of 0 (no pain) to 100 mm (worst possible pain). Higher scores indicate greater level of pain.
Measured: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
PhyGA: physician marked intensity of participants' pain on a visual analogue scale of 0 (no disease activity) to 100 mm (worst possible condition). Higher scores indicate greater level of disease activity.
Measured: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
PtGA: participant assessed their disease activity using a 100 mm visual analog scale ranging from 0 = very good to 100 = worst. Higher scores indicate worse health status.
Measured: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D)
EQ-5D: participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. For utility score, participants rated their current health state on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem.
Measured: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Duration of Morning Stiffness in Participants With Temporary Rigidity
Rigidity was temporary when 'Yes' was given for the question if daily activities could be done without stiffness; rigidity was permanent when 'No' was given for the question if daily activities could be done without stiffness.
Measured: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis
Participants with psoriatic arthritis were distributed in following different classes depending upon percentage (%) of BSA affected: 1) less than (<) 3 %, 2) 3-10%, 3) 11-20% and 4) >20%. Psoriatic arthritis affecting <3% BSA was considered as mild, 3 to 10 % as moderate and >10 percent as severe.
Measured: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Change From Baseline in Nail Involvement at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis
In this outcome measure change in number of nails affected by psoriatic arthritis at specified week compared to baseline is reported. Nails included both finger nails and toe nails.
Measured: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Change From Baseline in Inflamed Dactylitic Digits at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis
In this outcome measure change in number of inflamed dactylitic digits at specified week compared to baseline is reported. Dactylitis is inflammation of dactylitic digits (fingers and toes).
Measured: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156)
In this outcome measure number of participants with use of glucocorticoids and DMARDs at baseline and specified weeks are reported. If participants used glucocorticoids and DMARDs, it was denoted by "Yes" and if they did not use, it was denoted by "No". Data have been reported separately for glucocorticoids and DMARDs at specified weeks respectively, in 4 categories as: 1) Baseline: No and Specified Week: No, 2) Baseline: Yes and Specified Week: No, 3) Baseline: No and Specified Week: Yes, 4) Baseline: Yes and Specified Week: Yes.
Measured: Baseline, Week 78, 156
Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Continuation of Treatment With Etanercept
In this outcome number of participants who participated or not participated in RUDI and PIT and impact of their participation in continuation or termination of treatment with Etanercept is reported. For participants whom data was not recorded is reported under category "No Data".
Measured: Baseline up to Week 156
Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D)
In this outcome number of participants who participated or not participated in RUDI and PIT and impact of their participation in quality of life parameters using EQ-5D health questionnaire is reported. For participants whom data was not recorded is reported under category "No Data". EQ-5D: participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. For utility score, participants rated their current health state on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem.
Measured: Baseline up to Week 156

Timeline

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

Feb 2012Mar 2018

First posted20 Jun 2012 (estimated)
Study startFeb 2012
Primary completionMar 2018
Study completionMar 2018

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 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: 1,821 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01623752
Sponsor's protocol ID: B1801317
Acronym: PRERA
Status last verified: Jul 2019
First submitted: 18 Jun 2012
Last updated: 16 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Wassenberg S, Rau R, Klopsch T, Plenske A, Jobst J, Klaus P, Meng T, Loschmann PA. Etanercept is Effective and Halts Radiographic Progression in Rheumatoid Arthritis and Psoriatic Arthritis: Final Results from a German Non-interventional Study (PRERA). Rheumatol Ther. 2023 Feb;10(1):117-133. doi: 10.1007/s40744-022-00491-4. Epub 2022 Oct 17.
PubMed 36251174

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PROSPECTIVE EVALUATION OF THE RADIOGRAPHIC EFFICACY OF ETANERCEPT IN PATIENTS WITH RHEUMATOID ARTHRITIS OR PSORIATIC ARTHRITIS.
ClinicalTrials.gov ID: NCT01623752
Acronym / sponsor ID: PRERA / B1801317
Conditions: Rheumatoid Arthritis, Psoriasis Arthritis
Study type: Observational
Recruitment status: Completed
Enrolment: 1,821 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Feb 2012 (actual)
Primary completion: Mar 2018 (actual)
Study completion: Mar 2018 (actual)
First posted: 20 Jun 2012 (estimated)
Results: Posted 16 Aug 2019

Clinical summary

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

Therefore, no robust x-ray data are available to show/demonstrate

the average extent of x-ray damage in routine patients on Enbrel outside clinical studies.
if the outstanding effect on structural damage of Enbrel can be reproduced in routine practice.
that the 'Silent Progressor' is an issue relevant not only in clinical trials, but also for day-to-day decision making.
the optimal onset of Enbrel treatment in the course of the disease to prevent radiographic damage

Detailed description

Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Study design

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

Arm	Type	Receives
Patients with Rheumatoid Arthritis	–	Drug: Etanercept
Patients with Psoriasis Arthritis	–	Drug: Etanercept

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Only patients for whom the decision has already been made to initiate treatment with Enbrel® can be enrolled in this observational trial. These patients must have a proven diagnosis of Rheumatoid Arthritis or Psoriasis Arthritis

Key inclusion criteria (8 listed)

Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator's study team before subjects are included in the study.
Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study is a requirement for inclusion into this study.
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Definitive diagnosis of RA or PsA.

Key exclusion criteria (7 listed)

Receipt of any investigational drug within 3 months of study inclusion.
Exclusion Criteria according to the Enbrel® SmPC, with particular attention to:
Hypersensitivity to the active substance (etanercept) or to any of the excipients.
Sepsis or risk of sepsis.
Active infections, including chronic or localised infections.

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
EtanerceptAlso: EnbrelThe patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.	Drug	Patients with Rheumatoid Arthritis
EtanerceptAlso: EnbrelThe patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.	Drug	Patients with Psoriasis Arthritis

Primary outcome

Change From Baseline in Van Der Heijde Total Modified Total Sharp Score (mTSS) or Adapted mTSS at End of Phase 1 (Week 78): Efficacy Analysis Set (EAS)
Time frame: Baseline, Week 78
To assess radiological damage mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively.
Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 1 (Week 78): Completer Analysis Set (CAS)
Time frame: Baseline, Week 78
To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively.
Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at the End of Phase 2 (Week 156): EAS
Time frame: Baseline, Week 156
To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively.
Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 2 (Week 156): CAS
Time frame: Baseline, Week 156
To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively.
Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): EAS
Time frame: Pre-treatment, Week 78
The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (greater than [>] 0.5), no change (-0.5 to 0.5) and decrease (less than [<] -0.5). Participants with no change or a decrease were considered to be in radiographic remission.
Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): CAS
Time frame: Pre-treatment, Week 78
The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (>0.5), no change (-0.5 to 0.5) and decrease (<-0.5). Participants with no change or a decrease were considered to be in radiographic remission.
Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 2 (Week 156): EAS
Time frame: Pre-treatment, Week 156
The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (>0.5), no change (-0.5 to 0.5) and decrease (<-0.5). Participants with no change or a decrease were considered to be in radiographic remission.
Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at the End of Phase 2 (Week 156): CAS
Time frame: Pre-treatment, Week 156
The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (>0.5), no change (-0.5 to 0.5) and decrease (<-0.5). Participants with no change or a decrease were considered to be in radiographic remission.

24 secondary outcomes

Linear Relationship Between Normalized Radiographic Progression and Disease Duration
Time frame: Baseline up to Week 78
Effect on Normalized Radiographic Progression With Respect to Baseline Positivity of Anti-citrullinated Protein Antibody (ACPA) - Rheumatoid Factor (RF)
Time frame: Baseline up to Week 78
Effect on Normalized Radiographic Progression With Respect to Baseline Usage of Concomitant Medication
Time frame: Baseline up to Week 78
Effect on Normalized Radiographic Progression With Respect to Previous Treatment With Biologics
Time frame: Baseline up to Week 78
Effect on Normalized Radiographic Progression With Respect to Baseline Disease Activity Score-28 (DAS-28)
Time frame: Baseline up to Week 78
Change From Baseline in Total Erosion Score at End of Phase 1 (Week 78) and Phase 2 (Week 156)
Time frame: Baseline, Week 78, 156
Change From Baseline in Total Joint Space Narrow Score at End of Phase 1 (Week 78) and Phase 2 (Week 156)
Time frame: Baseline, Week 78, 156
Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Change From Baseline in Simple Disease Activity Index (SDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI)
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI)
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D)
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Duration of Morning Stiffness in Participants With Temporary Rigidity
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Change From Baseline in Nail Involvement at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Change From Baseline in Inflamed Dactylitic Digits at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156)
Time frame: Baseline, Week 78, 156
Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Continuation of Treatment With Etanercept
Time frame: Baseline up to Week 156
Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D)
Time frame: Baseline up to Week 156

Results and safety

Results posted to the registry on 16 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants With Rheumatoid Arthritis	1,378	747
Participants With Psoriatic Arthritis	440	233
Participants With Unclear Diagnosis	3	1

Primary outcome: Change From Baseline in Van Der Heijde Total Modified Total Sharp Score (mTSS) or Adapted mTSS at End of Phase 1 (Week 78): Efficacy Analysis Set (EAS)

Time frame: Baseline, Week 78. Mean (Standard Deviation). Unit: Units on a scale

Measure	Participants With Rheumatoid Arthritis n = 504	Participants With Psoriatic Arthritis n = 166
Baseline	25.1 (42.4)	14.7 (25.7)
Change at Week 78	0.6 (7.2)	-0.4 (5.9)

Population analysed: Efficacy analysis set for Phase 1= all participants who had received at least 1 dose of Etanercept and had baseline X-ray (Rx1) and end of phase 1 X-ray (Rx2). Here, "Overall Number of Participants Analyzed" =number of participants evaluable for this outcome measure; "Number Analyzed"=number of participants evaluable for the specified time points.

Primary outcome: Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 1 (Week 78): Completer Analysis Set (CAS)

Time frame: Baseline, Week 78. Mean (Standard Deviation). Unit: Units on a scale

Measure	Participants With Rheumatoid Arthritis n = 500	Participants With Psoriatic Arthritis n = 164
Baseline	25.3 (42.5)	14.7 (25.8)
Change at Week 78	0.6 (7.2)	-0.5 (5.8)

Population analysed: Completer analysis set for Phase 1: all participants who had received at least 1 dose of Etanercept and had clinical data for Rx1 and Rx2 and provided data for end of Phase 1 of study. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. "Number Analyzed"= participants evaluable for the specified time points.

Primary outcome: Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at the End of Phase 2 (Week 156): EAS

Time frame: Baseline, Week 156. Mean (Standard Deviation). Unit: Units on a scale

Measure	Participants With Rheumatoid Arthritis n = 97	Participants With Psoriatic Arthritis n = 48
Value	1.4 (9.9)	0.7 (8.2)

Population analysed: Efficacy analysis set for Phase 2 included all participants who had received at least 1 dose of Etanercept and had Rx1 and end of Phase 2 X-ray (Rx3). Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Primary outcome: Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 2 (Week 156): CAS

Time frame: Baseline, Week 156. Mean (Standard Deviation). Unit: Units on a scale

Measure	Participants With Rheumatoid Arthritis n = 96	Participants With Psoriatic Arthritis n = 48
Value	1.4 (9.9)	0.7 (8.2)

Population analysed: Completer analysis set for Phase 2 included all participants who had received at least 1 dose of Etanercept, and had clinical data for the obligatory X-ray (Rx1) and Rx3, and completed Phase 2 of the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

24 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Week 156. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants With Rheumatoid Arthritis	159 of 1,378 (11.5%)	579 of 1,378 (42%)	6 of 1,378
Participants With Psoriatic Arthritis	47 of 440 (10.7%)	167 of 440 (38%)	0 of 440
Participants With Unclear Diagnosis	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36251174Wassenberg S, Rau R, Klopsch T, Plenske A, Jobst J, Klaus P, Meng T, Loschmann PA. Etanercept is Effective and Halts Radiographic Progression in Rheumatoid Arthritis and Psoriatic Arthritis: Final Results from a German Non-interventional Study (PRERA). Rheumatol Ther. 2023 Feb;10(1):117-133. doi: 10.1007/s40744-022-00491-4. Epub 2022 Oct 17.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis and Psoriasis Arthritis, run by Pfizer.

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 8 inclusion and 7 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 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

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 16 Aug 2019). 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?

Change From Baseline in Van Der Heijde Total Modified Total Sharp Score (mTSS) or Adapted mTSS at End of Phase 1 (Week 78): Efficacy Analysis Set (EAS) (time frame: Baseline, Week 78). The study lists 8 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 NCT01623752, 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 16 Aug 2019.