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

Last updated on April 11, 2018

FOR MORE INFORMATION
Study Location
Algemeen Ziekenhuis St Jan
Brugge, , 8000 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid 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

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

Participation in other clinical or observational trials.

NCT01432366
Pfizer
Completed
Correlation Between Beliefs About Medicine and Objective Measures of Efficacy and Safety in Rheumatoid Arthritis (RA)

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Correlation Between Beliefs About Medicine and Objective Measures of Efficacy and Safety in Rheumatoid Arthritis (RA)
Subcutaneous Anti-tnf-?lpha In Rheumatoid Arthritis: Analyze The Correlation Between Objective Measures Of Disease Activity And Safety And A Subjective Measure Such As Patient Beliefs About A Medicine
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
rheumatoid arthritis patients treated with SC anti-TNF capable of completing some questionnaires
Rheumatoid Arthritis
Other: SC anti-TNF
Subcutaneous (SC) anti-TNF
Rheumatoid arthritis patients treated with SC anti-TNF
Intervention: Other: SC anti-TNF
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
460
January 2015
December 2013   (Final data collection date for primary outcome measure)

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

Exclusion Criteria:

Participation in other clinical or observational trials.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01432366
0881A1-4746
B1801047 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2015

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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