Observational Study to Research the Effectiveness of Adalimumab Treatment in Conjunction With Utilization of a Patient Support Program (PSP) (OPERA)
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| First Received Date ICMJE | June 26, 2011 | ||||||||
| Last Updated Date | April 26, 2013 | ||||||||
| Start Date ICMJE | September 2011 | ||||||||
| Estimated Primary Completion Date | November 2016 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Percentage of patients achieving Minimal Clinically Important Difference (MCID) in HAQ-DI at Week 78 compared to Baseline (change of at least -0.22 in HAQ-DI). [ Time Frame: Week 78 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01383421 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Observational Study to Research the Effectiveness of Adalimumab Treatment in Conjunction With Utilization of a Patient Support Program (PSP) | ||||||||
| Official Title ICMJE | A Post-Marketing Observational Study (PMOS) to Determine the Effectiveness and Patient Satisfaction With Adalimumab Treatment in Patients With Rheumatoid Arthritis (OPERA Study) | ||||||||
| Brief Summary | Post-marketing observational study to determine the effectiveness and patient satisfaction with adalimumab treatment in patients with Rheumatoid Arthritis in relation to utilization of a Patient Support Program (PSP). |
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| Detailed Description | This study is a non-confirmatory study to explore and describe the effectiveness of adalimumab on Rheumatoid Arthritis (RA) treatment course and patient satisfaction over time in context with utilization of a Patient Support Program (PSP). The main objectives are to examine the effectiveness of adalimumab treatment with respect to PSPs by means of Health Assessment Questionnaire Disability Index (HAQ-DI), Disease Activity Score (DAS28) results, and European League Against Rheumatism (EULAR) response criteria, as well as to evaluate the contribution of PSP to disease control, treatment continuation over time, patient's satisfaction, and PSP utilization. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Not Provided | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Representative disease population selected from rheumatology clinics in the countries selected. |
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| Condition ICMJE | Rheumatoid Arthritis | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Rheumatoid Arthitis patients receiving adalimumab commercially
All patients will have Rheumatoid Arthritis and will receive adalimumab commercially, with first dose corresponding to Baseline visit. |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 1500 | ||||||||
| Estimated Completion Date | November 2016 | ||||||||
| Estimated Primary Completion Date | November 2016 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Australia, Belgium, Czech Republic, France, Germany, Greece, Israel, Mexico, Netherlands, Portugal, Puerto Rico, Slovakia, Spain, Switzerland, United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01383421 | ||||||||
| Other Study ID Numbers ICMJE | P12-072 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | AbbVie ( AbbVie (prior sponsor, Abbott) ) | ||||||||
| Study Sponsor ICMJE | AbbVie (prior sponsor, Abbott) | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | AbbVie | ||||||||
| Verification Date | April 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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