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An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis

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.
 
ClinicalTrials.gov Identifier: NCT01357668
Recruitment Status : Recruiting
First Posted : May 23, 2011
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date May 19, 2011
First Posted Date May 23, 2011
Last Update Posted Date May 2, 2018
Actual Study Start Date January 31, 2013
Estimated Primary Completion Date December 31, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 20, 2011)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 20, 2011)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis
Official Title An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum
Sampling Method Non-Probability Sample
Study Population Pediatric rheumatology clinics
Condition Juvenile Idiopathic Arthritis
Intervention Not Provided
Study Groups/Cohorts Patients with JIA who are treated with Abatacept
Patients with JIA who are treated with Abatacept according to physicians'/families' decisions
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 20, 2011)
900
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2029
Estimated Primary Completion Date December 31, 2029   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages up to 17 Years   (Child)
Accepts Healthy Volunteers No
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
Listed Location Countries France,   Austria,   Brazil,   Canada,   Denmark,   Germany,   Greece,   Hungary,   Israel,   Italy,   Latvia,   Mexico,   Netherlands,   Norway,   Peru,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   Saudi Arabia,   Slovakia,   South Africa,   Spain,   United Kingdom,   United States
Removed Location Countries Argentina,   Belgium
 
Administrative Information
NCT Number NCT01357668
Other Study ID Numbers IM101-240
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor Bristol-Myers Squibb
Collaborators Not Provided
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date May 2018