Prospective Evaluation of the Radiographic Efficacy of Enbrel

NCT01623752 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1821

Last updated 2019-08-16

Study results available
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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

Conditions

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2018-03-31
Completion
2018-03-31

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01623752 on ClinicalTrials.gov