Observational Study to Research the Effectiveness of Adalimumab Treatment in Conjunction With Utilization of a Patient Support Program (PSP) (OPERA)
This study is currently recruiting participants.
Verified April 2013 by AbbVie
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01383421
First received: June 26, 2011
Last updated: April 26, 2013
Last verified: April 2013
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Purpose
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).
| Condition |
|---|
|
Rheumatoid Arthritis |
| Study Type: | Observational |
| Official Title: | A Post-Marketing Observational Study (PMOS) to Determine the Effectiveness and Patient Satisfaction With Adalimumab Treatment in Patients With Rheumatoid Arthritis (OPERA Study) |
Resource links provided by NLM:
MedlinePlus related topics:
Rheumatoid Arthritis
Drug Information available for:
Adalimumab
U.S. FDA Resources
Further study details as provided by AbbVie:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- Percentage of patients achieving Minimal Clinically Important Difference (MCID) in HAQ-DI at Week 12 compared to Baseline (change of at least -0.22 in HAQ-DI). [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- Percentage of patients achieving Minimal Clinically Important Difference (MCID) in HAQ-DI at Week 24 compared to Baseline(change of at least -0.22 in HAQ-DI). [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
- Percentage of patients achieving Minimal Clinically Important Difference (MCID) in HAQ-DI at Week 36 compared to Baseline (change of at least -0.22 in HAQ-DI). [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
- Percentage of patients achieving Minimal Clinically Important Difference (MCID) in HAQ-DI at Week 52 compared to Baseline (change of at least -0.22 in HAQ-DI). [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
- Percentage of patients achieving Minimal Clinically Important Difference (MCID) in HAQ-DI at Week 64 compared to Baseline (change of at least -0.22 in HAQ-DI). [ Time Frame: Week 64 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1500 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | November 2016 |
| Estimated Primary Completion Date: | November 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Rheumatoid Arthitis patients receiving adalimumab commercially
All patients will have Rheumatoid Arthritis and will receive adalimumab commercially, with first dose corresponding to Baseline visit.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Representative disease population selected from rheumatology clinics in the countries selected.
Criteria
Inclusion Criteria:
- 1. Male or female aged at least 18 years that has been newly prescribed adalimumab therapy according to the local product label, with the first dose corresponding to the Enrollment/Baseline visit.
- 2. Patient with a diagnosis of moderate to severe Rheumatoid Arthritis (RA), who has had insufficient response to one or more Disease-Modifying Antirheumatic Drugs (DMARDs), and has a prescription of adalimumab according to the local regulations.
- 3. Patients must have been evaluated (per local requirements) for tuberculosis risk factors or latent tuberculosis infection.
- 4. Patients must be able and willing to provide written authorization to disclose and use personal health information (and informed consent where applicable) and comply with the requirements of this study protocol as well as agree to data being collected and provided to Abbott.
Exclusion Criteria:
- 1. Patients should not be enrolled if they cannot be treated in accordance with the local adalimumab product label.
- 2. Patients treated with > 1 prior biologic Disease-modifying Anti-rheumatic Drug (DMARD) for Rheumatoid Arthritis (RA).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01383421
Show 101 Study Locations
Contacts
| Contact: Noreen Travers | 847-938-1785 | noreen.travers@abbvie.com |
| Contact: Lawrence McNamee | 610-746-9704 | Lawrence.McNamee@abbvie.com |
Show 101 Study LocationsSponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Director: | Hartmut Kupper, MD | AbbVie |
More Information
Additional Information:
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01383421 History of Changes |
| Other Study ID Numbers: | P12-072 |
| Study First Received: | June 26, 2011 |
| Last Updated: | April 26, 2013 |
| Health Authority: | Slovakia: State Institute for Drug Control Canada: Health Canada Mexico: Secretaria de Salud Israel: Ministry of Health Spain: Ministry of Health and Consumption France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Czech Republic: State Institute for Drug Control United States: Food and Drug Administration Belgium: Federal Agency for Medicinal Products and Health Products United Kingdom: Department of Health Netherlands: Medicines Evaluation Board (MEB) Portugal: National Pharmacy and Medicines Institute Australia: Department of Health and Ageing Therapeutic Goods Administration Germany: Ministry of Health Greece: Ministry of Health and Welfare |
Keywords provided by AbbVie:
|
Patient Support Program adalimumab Rheumatoid Arthritis |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases |
Immune System Diseases Adalimumab Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 18, 2013