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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

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ClinicalTrials.gov Identifier: NCT01694693
Recruitment Status : Withdrawn (Business objectives have changed)
First Posted : September 27, 2012
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:

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 or disease Intervention/treatment
Rheumatoid Arthritis Drug: Orencia

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

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Other
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
Estimated Study Start Date : January 31, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept
U.S. FDA Resources

Group/Cohort Intervention/treatment
RA patients treated by Orencia
RA patients treated by Orencia according to usual practice from June 1st 2007
Drug: Orencia
No Intervention



Primary Outcome Measures :
  1. Number of patients with first clinically significant Disease Activity Score (DAS) change [ Time Frame: Up to 5 Years ]

    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


  2. 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 ]
    EULAR response will be measured every 6 months during 5 years

  3. Number of patients with first Low Disease Activity State (LDAS) [ Time Frame: Up to 5 Years ]

    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


  4. Number of patients with first Remission state [ Time Frame: Up to 5 Years ]

    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


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

  11. Response over the time will be assessed over 5 years on EULAR response, LDAS [ Time Frame: Up to 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients included in SFR's ORA Registry
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694693


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

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01694693     History of Changes
Other Study ID Numbers: IM101-364
First Posted: September 27, 2012    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017

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