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

January 13, 2017 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

671

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient's survival and development of malignancies after treatment discontinuation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety measured by number of Adverse events and laboratory abnormalities associated with adverse events
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy measured by Patient's survival
Time Frame: 3 years
3 years
Efficacy measured by development of malignancies after treatment discontinuation
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

November 6, 2015

First Submitted That Met QC Criteria

November 6, 2015

First Posted (Estimate)

November 9, 2015

Study Record Updates

Last Update Posted (Estimate)

January 16, 2017

Last Update Submitted That Met QC Criteria

January 13, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM101-516

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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