An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis
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| ClinicalTrials.gov Identifier: NCT01357668 |
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Recruitment Status :
Recruiting
First Posted : May 23, 2011
Last Update Posted : March 24, 2022
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
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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.
| Condition or disease |
|---|
| Juvenile Idiopathic Arthritis |
| Study Type : | Observational |
| Estimated Enrollment : | 800 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis |
| Actual Study Start Date : | January 30, 2013 |
| Estimated Primary Completion Date : | January 2, 2029 |
| Estimated Study Completion Date : | January 2, 2029 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Juvenile idiopathic arthritis
Drug Information available for:
Abatacept
| Group/Cohort |
|---|
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Patients with JIA who are treated with Abatacept
Patients with JIA who are treated with Abatacept according to physicians'/families' decisions
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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
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| 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)
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: BMS Study Connect Contact Center www.BMSStudyConnect.com | 855-907-3286 | 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 |
Locations
| United States, New Jersey | |
| Bristol-Myers Squibb, Active | Recruiting |
| Princeton, New Jersey, United States, 08540 | |
| Contact: Mr Bristol-Myers Squibb, Site 0001 | |
| Austria | |
| Local Institution | Recruiting |
| Innsbruck, Austria, A-6020 | |
| Contact: Site 0002 | |
| Brazil | |
| Local Institution | Recruiting |
| Botucatu, Sao Paulo, Brazil, 18618-970 | |
| Contact: Site 0010 | |
| Canada, Quebec | |
| Local Institution | Recruiting |
| Montreal, Quebec, Canada, H4A 3J1 | |
| Contact: Site 0011 | |
| Denmark | |
| Local Institution | Recruiting |
| Copenhagen, Denmark, 2100 | |
| Contact: Site 0012 | |
| France | |
| Local Institution | Recruiting |
| Paris Cedex 15, France, 75743 | |
| Contact: Site 0005 | |
| Germany | |
| Local Institution | Recruiting |
| Bad Bramstedt, Germany, 24576 | |
| Contact: Site 0003 | |
| Greece | |
| Local Institution | Recruiting |
| Thessaloniki, Greece, 54642 | |
| Contact: Site 0016 | |
| Hungary | |
| Local Institution | Recruiting |
| Budapest, Hungary, H-1023 | |
| Contact: Site 0017 | |
| Israel | |
| Local Institution | Completed |
| Jerusalem, Israel, 91031 | |
| Italy | |
| Local Institution | Recruiting |
| Genova, Italy, 16147 | |
| Contact: Site 0015 | |
| Latvia | |
| Local Institution | Recruiting |
| Riga, Latvia, LV-1007 | |
| Contact: Site 0018 | |
| Mexico | |
| Local Institution | Recruiting |
| Guadalajara, Jalisco, Mexico, 44620 | |
| Contact: Site 0006 | |
| Netherlands | |
| Local Institution | Recruiting |
| Utrecht, Netherlands, 3584 EA | |
| Contact: Site 0019 | |
| Peru | |
| Local Institution | Recruiting |
| Lima, Peru, 1 | |
| Contact: Site 0007 | |
| Portugal | |
| Local Institution | Recruiting |
| Lisboa, Portugal, 1600 | |
| Contact: Site 0020 | |
| Puerto Rico | |
| Centro de Reumatologia Pediatrico de Puerto Rico | Completed |
| Bayamon, Puerto Rico, PR 960 | |
| Romania | |
| Local Institution | Recruiting |
| Cluj-Napoca, Romania | |
| Contact: Site 0021 | |
| Russian Federation | |
| Local Institution | Active, not recruiting |
| Moscow, Russian Federation, 119991 | |
| Slovakia | |
| Local Institution | Recruiting |
| Piestany, Slovakia | |
| Contact: Site 0022 | |
| South Africa | |
| Local Institution | Recruiting |
| Pretoria, Gauteng, South Africa, 0002 | |
| Contact: Site 0009 | |
| Spain | |
| Local Institution | Recruiting |
| Barcelona, Spain, 08035 | |
| Contact: Site 0004 | |
| United Kingdom | |
| Local Institution | Completed |
| Bristol, United Kingdom, BS2 8BJ | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01357668 |
| Other Study ID Numbers: |
IM101-240 |
| First Posted: | May 23, 2011 Key Record Dates |
| Last Update Posted: | March 24, 2022 |
| Last Verified: | March 2022 |
Additional relevant MeSH terms:
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Arthritis Arthritis, Juvenile Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |