Correlation Between Beliefs About Medicine and Objective Measures of Efficacy and Safety in Rheumatoid Arthritis (RA) (CONTENT)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Other: SC anti-TNF |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Subcutaneous Anti-tnf-α 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 |
- Correlation between patient beliefs about subcutaneous anti-TNF's Necessity and Disease Activity Score (DAS28) at year 1. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Correlation between Belief about Medicines Questionnaire (BMQ) Necessity and Safety at year 1. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Correlation between BMQ Concerns and DAS 28 at year 1. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Correlation between BMQ Concerns and Safety at year 1. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Rheumatoid arthritis patients treated with SC anti-TNF |
Other: SC anti-TNF
Subcutaneous (SC) anti-TNF
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
rheumatoid arthritis patients treated with SC anti-TNF capable of completing some questionnaires
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.
Contacts and Locations| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
| Belgium | |
| Algemeen Ziekenhuis Sint Jan | Recruiting |
| Brugge, Belgium, 8000 | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01432366 History of Changes |
| Other Study ID Numbers: | 0881A1-4746, B1801047 |
| Study First Received: | August 18, 2011 |
| Last Updated: | May 14, 2013 |
| Health Authority: | Belgium: Institutional Review Board |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013