Prospective Evaluation of the Radiographic Efficacy of Enbrel

NCT01623752

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis, Psoriasis Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Rheumatoid Arthritis, Psoriasis ArthritisProspective Evaluation of the Radiographic Efficacy of Enbrel
NCT01623752
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title 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.
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Rheumatoid Arthritis
  • Psoriasis Arthritis
Intervention 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.
Other Name: Enbrel
Study Groups/Cohorts
  • Patients with Rheumatoid Arthritis
    Intervention: Drug: Etanercept
  • Patients with Psoriasis Arthritis
    Intervention: Drug: Etanercept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 15, 2019)
1821
Original Estimated Enrollment
 (submitted: June 19, 2012)
1500
Actual Study Completion Date March 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01623752
Other Study ID Numbers B1801317
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description: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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2019