N/A
N=460
Correlation Between Beliefs About Medicine and Objective Measures of Efficacy and Safety in Rheumatoid Arthritis (RA)
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01432366 ↗Enrolled (actual)
460
Serious AEs
7.2%
Results posted
Jan 2016
Primary outcome: 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 correlation coefficient
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- SC anti-TNF (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2013
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 | — |
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.
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.