Observational Study to Research the Effectiveness of Adalimumab Treatment in Conjunction With Utilization of a Patient Support Program (PSP) (OPERA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01383421
First received: June 26, 2011
Last updated: October 10, 2014
Last verified: October 2014

June 26, 2011
October 10, 2014
September 2011
March 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01383421 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Percentage of patients achieving Minimal Clinically Important Difference (MCID) in HAQ-DI at Week 12 compared to Baseline. [ 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. [ 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. [ 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. [ 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. [ Time Frame: Week 64 ] [ Designated as safety issue: No ]
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Not Provided
 
Observational Study to Research the Effectiveness of Adalimumab Treatment in Conjunction With Utilization of a Patient Support Program (PSP)
A Post-Marketing Observational Study (PMOS) to Determine the Effectiveness and Patient Satisfaction With Adalimumab Treatment in Patients With Rheumatoid Arthritis (OPERA Study)

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).

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.

Observational
Not Provided
Not Provided
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Non-Probability Sample

Representative disease population selected from rheumatology clinics in the countries selected.

Rheumatoid Arthritis
Not Provided
Rheumatoid Arthitis patients receiving adalimumab commercially
All patients will have Rheumatoid Arthritis and will receive adalimumab commercially, with first dose corresponding to Baseline visit.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
March 2016
March 2016   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Czech Republic,   France,   Germany,   Greece,   Israel,   Mexico,   Netherlands,   Portugal,   Puerto Rico,   Slovakia,   Switzerland,   United Kingdom
 
NCT01383421
P12-072
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Jasmina Kalabic, MD AbbVie
AbbVie
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP