Clinical trial NCT01623752: Prospective Evaluation of the Radiographic Efficacy of Enbrel
Official title: A PROSPECTIVE EVALUATION OF THE RADIOGRAPHIC EFFICACY OF ETANERCEPT IN PATIENTS WITH RHEUMATOID ARTHRITIS OR PSORIATIC ARTHRITIS.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Psoriasis Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-06-20
Enrollment: 1821
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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 rheumatologic care and the local recommendations of Enbrel treatment (pre-treatment of at least 2 DMARDs, one of them MTX).

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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
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)
timeFrame: Baseline, Week 78
measure: 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)
timeFrame: Baseline, Week 78
measure: Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at the End of Phase 2 (Week 156): EAS
timeFrame: Baseline, Week 156
measure: Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 2 (Week 156): CAS
timeFrame: Baseline, Week 156
measure: Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): EAS
timeFrame: Pre-treatment, Week 78
measure: Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): CAS
timeFrame: Pre-treatment, Week 78
measure: Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 2 (Week 156): EAS
timeFrame: Pre-treatment, Week 156
measure: Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at the End of Phase 2 (Week 156): CAS
timeFrame: Pre-treatment, Week 156
Secondary outcomes:
measure: Linear Relationship Between Normalized Radiographic Progression and Disease Duration
timeFrame: Baseline up to Week 78
measure: Effect on Normalized Radiographic Progression With Respect to Baseline Positivity of Anti-citrullinated Protein Antibody (ACPA) - Rheumatoid Factor (RF)
timeFrame: Baseline up to Week 78
measure: Effect on Normalized Radiographic Progression With Respect to Baseline Usage of Concomitant Medication
timeFrame: Baseline up to Week 78
measure: Effect on Normalized Radiographic Progression With Respect to Previous Treatment With Biologics
timeFrame: Baseline up to Week 78
measure: Effect on Normalized Radiographic Progression With Respect to Baseline Disease Activity Score-28 (DAS-28)
timeFrame: Baseline up to Week 78
measure: Change From Baseline in Total Erosion Score at End of Phase 1 (Week 78) and Phase 2 (Week 156)
timeFrame: Baseline, Week 78, 156
measure: Change From Baseline in Total Joint Space Narrow Score at End of Phase 1 (Week 78) and Phase 2 (Week 156)
timeFrame: Baseline, Week 78, 156
measure: Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
timeFrame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
measure: Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
timeFrame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
measure: 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
timeFrame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
measure: 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
timeFrame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
measure: Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI)
timeFrame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
measure: Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI)
timeFrame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
measure: Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
timeFrame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
measure: Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
timeFrame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
measure: Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
timeFrame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
measure: Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D)
timeFrame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
measure: Duration of Morning Stiffness in Participants With Temporary Rigidity
timeFrame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
measure: Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis
timeFrame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
measure: Change From Baseline in Nail Involvement at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis
timeFrame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
measure: Change From Baseline in Inflamed Dactylitic Digits at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis
timeFrame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
measure: 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)
timeFrame: Baseline, Week 78, 156
measure: Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Continuation of Treatment With Etanercept
timeFrame: Baseline up to Week 156
measure: Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D)
timeFrame: Baseline up to Week 156
Other outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 156
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity
timeFrame: Baseline up to Week 156
measure: Number of Participants With Discontinuation of Etanercept Treatment
timeFrame: Week 78, 156
measure: Number of Participants With Treatment-Emergent Treatment Related Adverse Events
timeFrame: Baseline up to Week 156
measure: Number of Participants With Results of Tolerability Assessment by Physician and Participant
timeFrame: Week 78, 156
measure: Number of Participants With Pregnancy, Puerperium and Perinatal Conditions
timeFrame: Baseline up to Week 156
measure: Number of Participants Who Used Concomitant Medication
timeFrame: Baseline up to Week 156
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.