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Trial record 54 of 137 for:    "Connective Tissue Disease" | "Abatacept"

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Recruitment Status : Withdrawn (Business objectives have changed)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

Tracking Information
First Submitted Date September 24, 2012
First Posted Date September 27, 2012
Last Update Posted Date May 10, 2017
Estimated Study Start Date January 31, 2018
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 26, 2012)
  • 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
  • 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
  • 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
  • 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
  • Number of patients disease progression with prior improvement [ Time Frame: Up to 5 Years ]
  • Number of patients disease progression with no prior improvement [ Time Frame: Up to 5 Years ]
  • Number of patients with modification of Orencia administration condition [ Time Frame: Up to 5 Years ]
  • Number of patients discontinued and switched from Orencia [ Time Frame: Up to 5 Years ]
  • Incidence rate of any type of Adverse events related to Orencia [ Time Frame: Up to 5 Years ]
  • 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
  • Response over the time will be assessed over 5 years on EULAR response, LDAS [ Time Frame: Up to 5 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01694693 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief 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
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
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
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
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients included in SFR's ORA Registry
Condition Rheumatoid Arthritis
Intervention Drug: Orencia
No Intervention
Study Groups/Cohorts RA patients treated by Orencia
RA patients treated by Orencia according to usual practice from June 1st 2007
Intervention: Drug: Orencia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: May 9, 2017)
0
Original Actual Enrollment
 (submitted: September 26, 2012)
1031
Estimated Study Completion Date December 31, 2018
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01694693
Other Study ID Numbers IM101-364
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor Bristol-Myers Squibb
Collaborators Not Provided
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date May 2017