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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

460 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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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 ) versus the alternative that it is \> 0.3 (i.e., H1:│r │ \> 0.3 ) assuming the absolute value of the true correlation is 0.40. A total of 500 will be enrolled to allow for approximately 5% being lost from analysis due to lack of post baseline data.

The Pearson method will be used for correlation between the BMQ total score for Necessity and the DAS28 and between the BMQ total score for Concern and DAS28. The Spearman rank method will be used for correlation between the BMQ total scores and Safety. For these latter analyses, subjects will be classified into one of 3 safety categories: (1) No AEs, (2) Non-serious AEs, (3) Serious AEs. 95% confidence intervals for the correlations will be provided.

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rheumatoid arthritis patients treated with SC anti-TNF

SC anti-TNF

Intervention Type OTHER

Subcutaneous (SC) anti-TNF

Interventions

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SC anti-TNF

Subcutaneous (SC) anti-TNF

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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