We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis

This study is currently recruiting participants.
Verified October 2017 by Bristol-Myers Squibb
Sponsor:
ClinicalTrials.gov Identifier:
NCT01357668
First Posted: May 23, 2011
Last Update Posted: November 1, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
The purpose of this study is to examine the long-term safety of Abatacept for the treatment of juvenile idiopathic arthritis (JIA) with particular in interest in the occurrence of serious infections, autoimmune disorders, and malignancies.

Condition
Juvenile Idiopathic Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Incidence rate of serious infections [ Time Frame: 10 years ]
  • Incidence rate of malignancies [ Time Frame: 10 years ]
  • Incidence rate of autoimmune disorders [ Time Frame: 10 years ]

Secondary Outcome Measures:
  • Number of serious adverse events [ Time Frame: 10 years ]
  • Number of targeted infections (Epstein-Barr virus, cytomegalovirus, papilloma virus, herpes zoster, tuberculosis and opportunistic infections) [ Time Frame: 10 years ]

Biospecimen Retention:   Samples Without DNA
Serum

Estimated Enrollment: 900
Actual Study Start Date: January 31, 2013
Estimated Study Completion Date: December 31, 2029
Estimated Primary Completion Date: December 31, 2029 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with JIA who are treated with Abatacept
Patients with JIA who are treated with Abatacept according to physicians'/families' decisions

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric rheumatology clinics
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Diagnosis of JIA (any subtype)
  • Age < 18 years at the time of enrollment unless currently or previously enrolled in an abatacept clinical trial and received abatacept
  • Receiving Abatacept at the time of enrollment as per treating physician's decision or received abatacept in a clinical trial
  • Parent or legally acceptable representative willing to participate in the study and sign the informed consent

Exclusion Criteria:

  • Pregnant or nursing female at the time of enrollment
  • Prior malignancies if the patient has not been malignancy free for at least 5 years.
  • Any serious acute or chronic medical condition other than JIA, including chronic infection, which would compromise the patient's ability to participate in the study
  • Known poor compliance with clinic visits (based on physician judgment)
  Contacts and Locations
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): NCT01357668


Contacts
Contact: For participation information at a USA site use a phone number below. For Site information outside USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial site that are recruiting have contact information at this time

  Show 82 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01357668     History of Changes
Other Study ID Numbers: IM101-240
First Submitted: May 19, 2011
First Posted: May 23, 2011
Last Update Posted: November 1, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents