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. (see Contacts and Locations)
Verified July 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01383421
First received: June 26, 2011
Last updated: July 22, 2014
Last verified: July 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383421

Contacts
Contact: Saskia de Vente +31-620-744-795 saskia.devente@abbvie.com
Contact: Noreen Travers 847-938-1784 noreen.travers@abbvie.com

  Show 200 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Jasmina Kalabic, 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: July 22, 2014
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
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 18, 2014