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Survey on Long-Term Use of ORENCIA® Intravenous Infusion 250mg

Outline of Survey on Long-Term Use of ORENCIA® Intravenous Infusion 250mg

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02600468
Enrollment
671
Registered
2015-11-09
Start date
2013-09-30
Completion date
2015-12-31
Last updated
2017-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

The purpose of this study to collect information on the safety, especially serious infections and malignancies, and efficacy of the long-term use of ORENCIA Intravenous Infusion 250mg in patients with rheumatoid arthritis.

Interventions

Sponsors

Ono Pharmaceutical Co. Ltd
CollaboratorINDUSTRY
Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients who are beginning to receive the treatment with ORENCIA Intravenous Infusion 250mg under the approved indications, dosage, and administration * Have available HAQ data * Have available DAS28-ESR or DAS28- CRP data * Have no past or present history of malignancies * Are expected to be followed up for 3 years

Design outcomes

Primary

MeasureTime frame
Safety measured by number of Adverse events and laboratory abnormalities associated with adverse events3 years

Secondary

MeasureTime frame
Efficacy measured by Patient's survival3 years
Efficacy measured by development of malignancies after treatment discontinuation3 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026