Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01694693
First received: September 24, 2012
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

Database analysis:

  • To describe how Orencia is prescribed in France in Rheumatoid Arthritis (RA)
  • To describe joint population of Orencia
  • To assess the impact of the treatment on health status of the treated population as assessed by morbid-mortality criteria
  • To describe therapeutic strategies and use of health services

Condition Intervention
Patients Diagnosed With a Rheumatoid Arthritis According to ACR Criteria (American College of Rheumatology)
Drug: Orencia

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort Study

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Number of patients with first clinically significant Disease Activity Score (DAS) change [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]

    Change from DAS28 [C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)] measured at treatment initiation ≥ 1.2

    DAS28 will be measured every 6 months during 5 years


  • Number of patients with first response to treatment [according to definition of European League Against Rheumatism (EULAR) response criteria] [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]
    EULAR response will be measured every 6 months during 5 years

  • Number of patients with first Low Disease Activity State (LDAS) [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]

    Change from DAS28 [C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)] measured at treatment initiation ≤ 3.2

    DAS28 will be measured every 6 months during 5 years


  • Number of patients with first Remission state [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]

    Change from DAS28 [C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)] measured at treatment initiation <2.6

    DAS28 will be measured every 6 months during 5 years


  • Number of patients disease progression with prior improvement [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]
  • Number of patients disease progression with no prior improvement [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]
  • Number of patients with modification of Orencia administration condition [ Time Frame: Up to 5 Years ] [ Designated as safety issue: Yes ]
  • Number of patients discontinued and switched from Orencia [ Time Frame: Up to 5 Years ] [ Designated as safety issue: Yes ]
  • Incidence rate of any type of Adverse events related to Orencia [ Time Frame: Up to 5 Years ] [ Designated as safety issue: Yes ]
  • Number of patients with specific predefined events [ Time Frame: Up to 5 Years ] [ Designated as safety issue: Yes ]
    Predefined events are severe infection, thromboembolic events, cancer, lymphoma, other autoimmune disease, cutaneous disorder, significant or persistent disability, death

  • Response over the time will be assessed over 5 years on EULAR response, LDAS [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 1031
Study Start Date: July 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
RA patients treated by Orencia
RA patients treated by Orencia according to usual practice from June 1st 2007
Drug: Orencia
No Intervention

Detailed Description:
  • Observational Model: Historic cohort generated from Société Française de Rhumatologie's (SFR) Orencia and Rheumatoid Arthritis (ORA) registry
  • Sampling Method: all physicians and sites taking in charge RA patients received an invitation mailing to participate to ORA
  • Minimum Age: 18 years old at Orencia initiation
  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

Patients included in SFR's ORA Registry

Criteria

Inclusion Criteria:

  • Adult outpatients, male or female aged ≥ 18 years old
  • Diagnosed with a rheumatoid arthritis according to ACR criteria
  • Treated with Orencia according to usual practice conditions from June 1st 2007
  • Agreeing to participate

Exclusion Criteria:

  • Patients treated by Orencia in the context of clinical trials
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01694693

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01694693     History of Changes
Other Study ID Numbers: IM101-364
Study First Received: September 24, 2012
Last Updated: September 26, 2012
Health Authority: France: Haute Autorité de Santé Transparency Commission

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abatacept
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014