Correlation Between Beliefs About Medicine and Objective Measures of Efficacy and Safety in Rheumatoid Arthritis (RA)
NCT01432366
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Adult Trials: 18+ Years
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
Participation in other clinical or observational trials.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Correlation Between Beliefs About Medicine and Objective Measures of Efficacy and Safety in Rheumatoid Arthritis (RA) | |||
| Official Title | 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 | |||
| 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. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Probability Sample | |||
| Study Population | rheumatoid arthritis patients treated with SC anti-TNF capable of completing some questionnaires | |||
| Condition | Rheumatoid Arthritis | |||
| Intervention | Other: SC anti-TNF
Subcutaneous (SC) anti-TNF | |||
| Study Groups/Cohorts | Rheumatoid arthritis patients treated with SC anti-TNF
Intervention: Other: SC anti-TNF | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 460 | |||
| Original Estimated Enrollment | 500 | |||
| Actual Study Completion Date | January 2015 | |||
| Actual Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | |||
| 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. | |||
| Sex/Gender |
| |||
| Ages | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Belgium | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT01432366 | |||
| Other Study ID Numbers | 0881A1-4746 B1801047 ( Other Identifier: Alias Study Number ) | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | December 2015 | |||