Juvenile Idiopathic ArthritisNCT01357668
An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis
An observational study of Juvenile Idiopathic Arthritis, run by Bristol-Myers Squibb at 59 sites in 25 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- How many people
- 800 participants
- Where
- 59 sitesin 25 countries
- Study dates
- 30 Jan 2013to 2 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric rheumatology clinics
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
59 sites in 25 countries.
59 sites in 25 countries
Italy6 sites
Local Institution - 0042
Florence, 50139
Local Institution - 0015
Genova, 16147
Local Institution - 0043
Naples, 80131
Local Institution - 0045
Naples, 80138
Local Institution - 0044
Padova, 35128
Local Institution - 0046
Trento, 38100
Germany5 sites
Local Institution - 0003
Bad Bramstedt, 24576
Local Institution - 0030
Berlin, 10117
Local Institution - 0034
Freiburg im Breisgau, 79106
Local Institution - 0031
Hamburg, 22391
Local Institution - 0033
Heidelberg, 69120
Spain5 sites
Local Institution - 0004
Barcelona, 08035
Local Institution - 0038
Madrid, 28046
Local Institution - 0037
Murcia, 30120
Local Institution - 0036
Sant Joan Despí, Barcelona, 08970
Local Institution - 0039
Valencia, 46009
Brazil4 sites
Local Institution - 0010
Botucatu, São Paulo, 18618-970
Local Institution - 0026
Campinas, São Paulo, 13083-888
Local Institution - 0027
Rio de Janeiro, 22250-110
Local Institution - 0028
São Paulo, São Paulo, 04023-061
Russia4 sites
Local Institution - 0051
Moscow, 115522
Local Institution
Moscow, 119991
Local Institution - 0053
Saint Petersburg, 194100
Local Institution - 0052
Saratov, 410054
United States3 sites
Local Institution - 0059
Cincinnati, Ohio, 45229
Local Institution - 0060
Little Rock, Arkansas, 72202
Local Institution - 0001
Princeton, New Jersey, 08540
Austria3 sites
Local Institution - 0025
Bregenz, 0
Local Institution - 0002
Innsbruck, A-6020
Local Institution - 0032
Vienna, 1160
France3 sites
Local Institution - 0040
Clermont-Ferrand, Puy-de-Dôme, 63000
Local Institution - 0005
Paris, 75743
Local Institution - 0041
Toulouse, 31059
South Africa3 sites
Local Institution - 0057
Panorama, Cape Town, Western Cape, 7500
Local Institution - 0009
Pretoria, Gauteng, 0002
Local Institution - 0058
Pretoria, 0084
Canada2 sites
Local Institution - 0029
Calgary, Alberta, T3B 6A8
Local Institution - 0011
Montreal, Quebec, H4A 3J1
Denmark2 sites
Local Institution - 0035
Aarhus, Central Jutland, 8200
Local Institution - 0012
Copenhagen, 2100
Netherlands2 sites
Local Institution - 0047
Rotterdam, 3015 CE
Local Institution - 0019
Utrecht, 3584 EA
Norway2 sites
Local Institution - 0048
Tromsø, 9019
Local Institution - 0049
Trondheim, 7006
Peru2 sites
Local Institution - 0007
Lima, 1
Local Institution - 0050
Lima, LIMA 14
Puerto Rico2 sites
Local Institution - 0023
Bayamón, PR 960
Local Institution - 0056
Bayamón, PR 960
Saudi Arabia2 sites
Local Institution - 0055
Jeddah, 21159
Local Institution - 0024
Riyadh, 11426
About this study
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.
- Conditions
- Juvenile Idiopathic Arthritis
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with JIA who are treated with Abatacept | Patients with JIA who are treated with Abatacept according to physicians'/families' decisions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of serious infections
Measured: 10 years
Incidence rate of malignancies
Measured: 10 years
Incidence rate of autoimmune disorders
Measured: 10 years
Secondary outcomes (2)
Number of serious adverse events
Measured: 10 years
Number of targeted infections (Epstein-Barr virus, cytomegalovirus, papilloma virus, herpes zoster, tuberculosis and opportunistic infections)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study start30 Jan 2013
- Primary completion2 Jan 2029 (estimated)
- Study completion2 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357668
- Sponsor's protocol ID
- IM101-240
- Status last verified
- Sep 2025
- First submitted
- 19 May 2011
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Lovell DJ, Tzaribachev N, Henrickson M, Simonini G, Griffin TA, Alexeeva E, Bohnsack JF, Zeft A, Horneff G, Vehe RK, Stanevica V, Tarvin S, Trachana M, Del Rio AQ, Huber AM, Kietz D, Orban I, Dare J, Foeldvari I, Quartier P, Dominique A, Simon TA, Martini A, Brunner HI, Ruperto N; for PRINTO and the Pediatric Rheumatology Collaborative Study Group (PRCSG) section sign. Safety and effectiveness of abatacept in juvenile idiopathic arthritis: results from the PRINTO/PRCSG registry. Rheumatology (Oxford). 2024 Sep 1;63(SI2):SI195-SI206. doi: 10.1093/rheumatology/keae025.
PubMed 38243722
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT01357668
- Acronym / sponsor ID
- IM101-240
- Conditions
- Juvenile Idiopathic Arthritis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2013 (actual)
- Primary completion
- 2 Jan 2029 (estimated)
- Study completion
- 2 Jan 2029 (estimated)
- First posted
- 23 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with JIA who are treated with Abatacept | – | –Patients with JIA who are treated with Abatacept according to physicians'/families' decisions |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric rheumatology clinics
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Derived from this study: PubMed 38243722Lovell DJ, Tzaribachev N, Henrickson M, Simonini G, Griffin TA, Alexeeva E, Bohnsack JF, Zeft A, Horneff G, Vehe RK, Stanevica V, Tarvin S, Trachana M, Del Rio AQ, Huber AM, Kietz D, Orban I, Dare J, Foeldvari I, Quartier P, Dominique A, Simon TA, Martini A, Brunner HI, Ruperto N; for PRINTO and the Pediatric Rheumatology Collaborative Study Group (PRCSG) section sign. Safety and effectiveness of abatacept in juvenile idiopathic arthritis: results from the PRINTO/PRCSG registry. Rheumatology (Oxford). 2024 Sep 1;63(SI2):SI195-SI206. doi: 10.1093/rheumatology/keae025.
- BMS Clinical Trial InformationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
59 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis, run by Bristol-Myers Squibb at 59 sites in 25 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in Italy, Germany, Spain, Brazil, Russia and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of serious infections (time frame: 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01357668, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.