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

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ClinicalTrials.gov Identifier: NCT02600468
Recruitment Status : Completed
First Posted : November 9, 2015
Last Update Posted : January 16, 2017
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Orencia

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Study Type : Observational
Actual Enrollment : 671 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outline of Survey on Long-Term Use of ORENCIA® Intravenous Infusion 250mg
Study Start Date : September 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis
Drug Information available for: Abatacept

Group/Cohort Intervention/treatment
Patients who use ORENCIA
Patients who use ORENCIA for the approved indications and who at the start of treatment
Drug: Orencia



Primary Outcome Measures :
  1. Safety measured by number of Adverse events and laboratory abnormalities associated with adverse events [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Efficacy measured by Patient's survival [ Time Frame: 3 years ]
  2. Efficacy measured by development of malignancies after treatment discontinuation [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient's survival and development of malignancies after treatment discontinuation
Criteria

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

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): NCT02600468


Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02600468     History of Changes
Other Study ID Numbers: IM101-516
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Connective Tissue Diseases
Abatacept
Immunosuppressive Agents
Physiological Effects of Drugs
Antirheumatic Agents
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors