Prospective Evaluation of the Radiographic Efficacy of Enbrel (PRERA)

Pfizer

Status

Completed

Conditions

Psoriasis Arthritis

Rheumatoid Arthritis

Treatments

Drug: Etanercept

Study type

Observational

Funder types

Industry

Identifiers

NCT01623752

B1801317

Details and patient eligibility

About

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

Full description

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

Enrollment

1,821 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.