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

NCT01694693 | Withdrawn

• 1 other identifier: IM101-364
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (11)

• Number of patients with first clinically significant Disease Activity Score (DAS) change

  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

  Up to 5 Years

• Number of patients with first response to treatment [according to definition of European League Against Rheumatism (EULAR) response criteria]

  EULAR response will be measured every 6 months during 5 years

  Up to 5 Years

• Number of patients with first Low Disease Activity State (LDAS)

  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

  Up to 5 Years

• Number of patients with first Remission state

  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

  Up to 5 Years

• Number of patients disease progression with prior improvement

  Up to 5 Years

• Number of patients disease progression with no prior improvement

  Up to 5 Years

• Number of patients with modification of Orencia administration condition

  Up to 5 Years

• Number of patients discontinued and switched from Orencia

  Up to 5 Years

• Incidence rate of any type of Adverse events related to Orencia

  Up to 5 Years

• Number of patients with specific predefined events

  Predefined events are severe infection, thromboembolic events, cancer, lymphoma, other autoimmune disease, cutaneous disorder, significant or persistent disability, death

  Up to 5 Years

• Response over the time will be assessed over 5 years on EULAR response, LDAS

  Up to 5 years

Study Arms (1)

RA patients treated by Orencia

RA patients treated by Orencia according to usual practice from June 1st 2007

Drug: Orencia

Interventions

Orencia DRUG

No Intervention

RA patients treated by Orencia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients included in SFR's ORA Registry

You may qualify if:

• 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

You may not qualify if:

• Patients treated by Orencia in the context of clinical trials

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

• Investigator Inquiry Form

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: September 27, 2012
• Study Start: January 31, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: May 10, 2017

Record last verified: 2017-05