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Use-Results Survey for ORENCIA® Subcutaneous Injection 125mg Syringe 1mL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02600455
Recruitment Status : Completed
First Posted : November 9, 2015
Last Update Posted : January 13, 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 localized injection site reactions, and efficacy of ORENCIA Subcutaneous Injection 125mg Syringe 1mL in patients with rheumatoid arthritis.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Orencia

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Study Type : Observational
Actual Enrollment : 505 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outline of Use-Results Survey for ORENCIA® Subcutaneous Injection 125mg Syringe 1mL
Study Start Date : September 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis
Drug Information available for: Abatacept

Group/Cohort Intervention/treatment
Patients who are treated with ORENCIA
Patients who are treated with ORENCIA according to the approved indications, and dosage and administration
Drug: Orencia



Primary Outcome Measures :
  1. Safety measured by number of Adverse events and laboratory abnormalities associated with adverse events [ Time Frame: 24 weeks ]


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:   Probability Sample
Study Population
Patients who are treated with ORENCIA according to the approved indications, and dosage and administration.
Criteria

Inclusion Criteria:

  • Patients who are beginning to receive the treatment with ORENCIA Subcutaneous Injection 125mg Syringe 1mL under the approved indications, dosage, and administration

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): NCT02600455


Locations
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Japan
Local Institution
Shinjuku-ku, Tokyo, Japan, 162-0822
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: NCT02600455     History of Changes
Other Study ID Numbers: IM101-515
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: January 13, 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