Status:

COMPLETED

Correlation Between Beliefs About Medicine and Objective Measures of Efficacy and Safety in Rheumatoid Arthritis (RA)

Lead Sponsor:

Pfizer

Conditions:

Rheumatoid Arthritis

Eligibility:

All Genders

18+ years

Brief Summary

It can be assumed that there is a link between what the patient feels and thinks about his medication and objective measures of disease activity and safety.

Detailed Description

A total of 500 subjects will provide 80% power to test the hypothesis that the absolute value of the correlation between two measures (e.g., BMQ Necessity and DAS28) is ≤ 0.3 (i.e., H0:│r│ ≤ 0.3 ) ver...

Eligibility Criteria

Inclusion

  • Patients with RA on stable therapy defined as:
  • Etanercept: 1x50 mg/week or 2x25mg/week for at least 1 consecutive year. Adalimumab: 1x40 mg every other week for at least 1 consecutive year. Oral corticosteroids: stable doses for ≥ 12 weeks before baseline Methotrexate: stable doses for ≥ 12 weeks before baseline Other DMARD's: stable doses for ≥ 12 weeks before baseline

Exclusion

  • Participation in other clinical or observational trials.

Key Trial Info

Start Date :

October 1 2010

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 1 2015

Estimated Enrollment :

460 Patients enrolled

Trial Details

Trial ID

NCT01432366

Start Date

October 1 2010

End Date

January 1 2015

Last Update

January 20 2016

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Algemeen Ziekenhuis St Jan

Bruges, Belgium, 8000