Clinical trial NCT01432366: Correlation Between Beliefs About Medicine and Objective Measures of Efficacy and Safety in Rheumatoid Arthritis (RA)
Official title: Subcutaneous Anti-tnf-αlpha 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-09-13
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: rheumatoid arthritis patients treated with SC anti-TNF capable of completing some questionnaires

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 ) 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation Between Beliefs About Medicines Questionnaire (BMQ) Necessity Score and Disease Activity Score Based on 28 Joints Count (DAS28) at Month 12
timeFrame: Month 12
Secondary outcomes:
measure: Correlation Between Beliefs About Medicines Questionnaire Necessity Score and Safety at Month 12
timeFrame: Month 12
measure: Correlation Between Beliefs About Medicines Questionnaire Concerns Score and Disease Activity Score Based on 28 Joints Count at Month 12
timeFrame: Month 12
measure: Correlation Between Beliefs About Medicines Questionnaire Concerns Score and Safety at Month 12
timeFrame: Month 12
measure: Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Disease Activity Score Based on 28 Joints Count
timeFrame: Month 6, 12
measure: Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Safety
timeFrame: Month 6, 12
measure: Correlation Between Evolution of Beliefs About Medicines Questionnaire Concerns and Disease Activity Score Based on 28 Joints Count
timeFrame: Month 6, 12
measure: Correlation Between Evolution of Beliefs About Medicines Questionnaire Concerns and Safety
timeFrame: Month 6, 12
measure: Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline
timeFrame: Baseline
measure: Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
timeFrame: Month 6, 12
measure: Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12
timeFrame: Baseline, Month 12
measure: Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale (MARS) at Baseline
timeFrame: Baseline
measure: Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale at Month 6 and 12
timeFrame: Month 6, 12
measure: Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Necessity Score at Baseline
timeFrame: Baseline
measure: Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Concerns Score at Baseline
timeFrame: Baseline
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Algemeen Ziekenhuis St Jan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: