Prospective Evaluation of the Radiographic Efficacy of Enbrel

NCT ID: NCT01623752

Last Updated: 2019-08-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1821 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2018-03-31

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

Conditions

Rheumatoid Arthritis; Psoriasis Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with Rheumatoid Arthritis

Etanercept

Intervention Type: DRUG

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.

Patients with Psoriasis Arthritis

Etanercept

Intervention Type: DRUG

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.

Interventions

Etanercept

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.

Intervention Type: DRUG

Etanercept

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.

Intervention Type: DRUG

Other Intervention Names

Enbrel; Enbrel

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 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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

References

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.

Reference Type: DERIVED

PMID: 36251174 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1801317&StudyName=Prospective%20Evaluation%20of%20the%20Radiographic%20Efficacy%20of%20Enbrel%20

To obtain contact information for a study center near you, click here.

Other Identifiers

B1801317

Identifier Type: -

Identifier Source: org_study_id