N/A
Completed N=460
Correlation Between Beliefs About Medicine and Objective Measures of Efficacy and Safety in Rheumatoid Arthritis (RA)
Source: ClinicalTrials.gov NCT01432366 ↗Enrolled (actual)
460
Serious AEs
7.2%
Results posted
Jan 2016
Primary outcomePrimary: Correlation Between Beliefs About Medicines Questionnaire (BMQ) Necessity Score and Disease Activity Score Based on 28 Joints Count (DAS28) at Month 12 — -0.06 correlation coefficient
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation Between Beliefs About Medicines Questionnaire (BMQ) Necessity Score and Disease Activity Score Based on 28 Joints Count (DAS28) at Month 12 |
-0.06 | — |
| SECONDARY Correlation Between Beliefs About Medicines Questionnaire Necessity Score and Safety at Month 12 |
-0.03 | — |
| SECONDARY Correlation Between Beliefs About Medicines Questionnaire Concerns Score and Disease Activity Score Based on 28 Joints Count at Month 12 |
0.10 | — |
| SECONDARY Correlation Between Beliefs About Medicines Questionnaire Concerns Score and Safety at Month 12 |
0.03 | — |
| SECONDARY Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Disease Activity Score Based on 28 Joints Count |
-0.05; -0.09 | — |
| SECONDARY Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Safety |
0.01; -0.05 | — |
| SECONDARY Correlation Between Evolution of Beliefs About Medicines Questionnaire Concerns and Disease Activity Score Based on 28 Joints Count |
0.07; 0.02 | — |
| SECONDARY Correlation Between Evolution of Beliefs About Medicines Questionnaire Concerns and Safety |
0.03; 0.01 | — |
| SECONDARY Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline |
44.6; 49.3; 35.5; 10.4; 41.3; 43.9 | — |
| SECONDARY Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12 |
47.0; 46.6; 45.9; 47.1; 33.7; 31.4 | — |
| SECONDARY Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12 |
93.3; 0.3; 45.8; -7.1; 85.0; 0 | — |
| SECONDARY Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale (MARS) at Baseline |
0.13; -0.18; 0.22; -0.17; -0.10 | — |
| SECONDARY Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale at Month 6 and 12 |
0.18; 0.16; -0.15; -0.24; 0.22; 0.27 | — |
| SECONDARY Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Necessity Score at Baseline |
-0.030; -0.090; -0.048; -0.008; 0.11; 0.13 | — |
| SECONDARY Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Concerns Score at Baseline |
-0.078; 0.057; -0.052; -0.098; -0.06; -0.08 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01432366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.