Refractory Systemic Juvenile Idiopathic ArthritisNCT07845942
Allogeneic Hematopoietic Cell Transplantation for Refractory Systemic Juvenile Idiopathic Arthritis.
An observational study of Refractory Systemic Juvenile Idiopathic Arthritis and Systemic Juvenile Idiopathic Arthritis, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The goal of this study is to collect clinical data and samples and to evaluate the feasibility of allogeneic hematopoietic cell transplantation (HCT) in children and young adults with refractory Systemic Juvenile Idiopathic Arthritis (sJIA), including those with sJIA-associated lung disease (sJIA-LD). Read more about this study
- Who is it for?
- Ages Up to 35 years
- Conditions the study is for
- Refractory Systemic Juvenile Idiopathic Arthritis, Systemic Juvenile Idiopathic Arthritis, Systemic Juvenile Idiopathic Arthritis Associated Lung Disease
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jul 2031
- 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 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and young adults <35 years of age with longstanding Systemic Juvenile Idiopathic Arthritis diagnosed in childhood will be enrolled if they meet the eligibility criteria below. Patients with Systemic Juvenile Idiopathic Arthritis associated lung disease are included and will be specifically evaluated.
Who may be able to join
- Patients <35 years of age are eligible, and participants must meet all the following criteria to be eligible for this study:
- Diagnosis: Systemic Juvenile Idiopathic Arthritis (sJIA) diagnosed prior to age 16, fulfilling ILAR classification criteria for sJIA or the provisional PRINTO criteria for systemic arthritis. The diagnosis and disease course must be reviewed and confirmed by a pediatric rheumatologist.
- Refractory Disease: sJIA that is refractory to standard therapy, defined as meeting at least one of these conditions despite appropriate treatment:
- Persistent JIA activity: Ongoing active disease (e.g. uncontrolled arthritis or systemic features such as fever, rash, organ inflammation) or progressive joint damage or liver dysfunction that has not responded to biologic agents (IL-1/IL-6 inhibitors) and conventional therapies, or inability to wean from high-dose corticosteroids (steroid dependence).
- Recurrent MAS: Two or more episodes of macrophage activation syndrome within a 2-year period, indicating a failure to control the hyperinflammation with medical management. (MAS is defined by clinical and laboratory criteria such as fever, cytopenias, hyperferritinemia, hemophagocytosis, etc., per standard definitions.)
- sJIA-LD: Presence of lung disease related to sJIA, either symptomatic LD (e.g. chronic cough, tachypnea, hypoxemia) or progressive LD on imaging (worsening interstitial changes), meeting clinical/imaging features such as patchy ground-glass opacities, septal and pleural thickening, or clubbing of digits. sJIA-LD should be confirmed by a pulmonologist/radiologist (e.g. HRCT findings).
Who cannot join
- Uncontrolled Infection: Presence of a severe, uncontrolled infection at time of enrollment (e.g. sepsis, pneumonia not responding to therapy).
- Significant Organ Failure:
- Cardiac: EF < 40%
- Renal: GFR < 30 ml/hr
- Active Malignancy: Concurrent cancer diagnosis or history of malignant disease requiring active treatment.
- Pregnancy or Lactation: Female patients who are pregnant or breastfeeding. Female participants of childbearing potential must have a negative pregnancy test clinical result at screening (pregnancy testing is done as standard of care for all transplant patients).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Sharat Chandra, MD, 513-636-5917, Sharat.Chandra@cchmc.org
Sharat Chandra, MD
About this study
Official title: Allogeneic Hematopoietic Cell Transplantation for Refractory Systemic Juvenile Idiopathic Arthritis: A Single-Center Prospective Trial
The goal of this study is to collect clinical data and samples and to evaluate the feasibility of allogeneic hematopoietic cell transplantation (HCT) in children and young adults with refractory Systemic Juvenile Idiopathic Arthritis (sJIA), including those with sJIA-associated lung disease (sJIA-LD).
- Conditions
- Refractory Systemic Juvenile Idiopathic Arthritis, Systemic Juvenile Idiopathic Arthritis, Systemic Juvenile Idiopathic Arthritis Associated Lung Disease
- Medical subject headings
- Arthritis, Juvenile
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival at 1 year
Measured: 1-year post-transplant
Secondary outcomes (6)
sJIA clinical remission
Proportion achieving clinical remission/ inactive diasease at 1 year
Measured: 1-year post-transplant
Corticosteroid and biologic independence
Time to discontinuation of corticosteroids and biologic therapy following HCT.
Measured: Time Frame: 1-year post-transplant
Graft Failure
Incidence of primary and secondary graft failure following HCT.
Measured: 1-year post-transplant
Acute and Chronic Graft-Versus-Host Disease (GVHD)
Incidence and severity of acute and chronic GVHD following HCT.
Measured: 1-year post-transplant
Transplant-Related Mortality
Incidence of mortality attributable to transplant-related complications.
Measured: 1-year post-transplant
Pulmonary Outcomes in Participants With sJIA-LD
Changes in pulmonary disease following HCT, assessed using pulmonary function testing and physician global assessment of lung disease (PGALD).
Measured: 1-year post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionJul 2031 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Systemic Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharat Chandra, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845942
- Sponsor's protocol ID
- 2025-0767
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Hematopoietic Cell Transplantation for Refractory Systemic Juvenile Idiopathic Arthritis: A Single-Center Prospective Trial
- ClinicalTrials.gov ID
- NCT07845942
- Acronym / sponsor ID
- 2025-0767
- Conditions
- Refractory Systemic Juvenile Idiopathic Arthritis, Systemic Juvenile Idiopathic Arthritis, Systemic Juvenile Idiopathic Arthritis Associated Lung Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jul 2031 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 29 Sep 2026 (actual)
- 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 goal of this study is to collect clinical data and samples and to evaluate the feasibility of allogeneic hematopoietic cell transplantation (HCT) in children and young adults with refractory Systemic Juvenile Idiopathic Arthritis (sJIA), including those with sJIA-associated lung disease (sJIA-LD).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and young adults <35 years of age with longstanding Systemic Juvenile Idiopathic Arthritis diagnosed in childhood will be enrolled if they meet the eligibility criteria below. Patients with Systemic Juvenile Idiopathic Arthritis associated lung disease are included and will be specifically evaluated.
Key inclusion criteria (6 listed)
- Patients <35 years of age are eligible, and participants must meet all the following criteria to be eligible for this study:
- Diagnosis: Systemic Juvenile Idiopathic Arthritis (sJIA) diagnosed prior to age 16, fulfilling ILAR classification criteria for sJIA or the provisional PRINTO criteria for systemic arthritis. The diagnosis and disease course must be reviewed and confirmed by a pediatric rheumatologist.
- Refractory Disease: sJIA that is refractory to standard therapy, defined as meeting at least one of these conditions despite appropriate treatment:
- Persistent JIA activity: Ongoing active disease (e.g. uncontrolled arthritis or systemic features such as fever, rash, organ inflammation) or progressive joint damage or liver dysfunction that has not responded to biologic agents (IL-1/IL-6 inhibitors) and conventional therapies, or inability to wean from high-dose corticosteroids (steroid dependence).
- Recurrent MAS: Two or more episodes of macrophage activation syndrome within a 2-year period, indicating a failure to control the hyperinflammation with medical management. (MAS is defined by clinical and laboratory criteria such as fever, cytopenias, hyperferritinemia, hemophagocytosis, etc., per standard definitions.)
Key exclusion criteria (6 listed)
- Uncontrolled Infection: Presence of a severe, uncontrolled infection at time of enrollment (e.g. sepsis, pneumonia not responding to therapy).
- Significant Organ Failure:
- Cardiac: EF < 40%
- Renal: GFR < 30 ml/hr
- Active Malignancy: Concurrent cancer diagnosis or history of malignant disease requiring active treatment.
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
Overall Survival at 1 year
Time frame: 1-year post-transplant
6 secondary outcomes
sJIA clinical remission
Time frame: 1-year post-transplant
Corticosteroid and biologic independence
Time frame: Time Frame: 1-year post-transplant
Graft Failure
Time frame: 1-year post-transplant
Acute and Chronic Graft-Versus-Host Disease (GVHD)
Time frame: 1-year post-transplant
Transplant-Related Mortality
Time frame: 1-year post-transplant
Pulmonary Outcomes in Participants With sJIA-LD
Time frame: 1-year post-transplant
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 29 Sep 2026.
Related trials for Refractory Systemic Juvenile Idiopathic Arthritis
RecruitingPhase 1
Clinical Study of BCMA/CD70-targeted CAR-T Therapy for Refractory Pediatric Rheumatic Diseases
Juvenile Dermatomyositis (JDM), Polyarticular Juvenile Idiopathic Arthritis
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.
Sharat Chandra, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractory Systemic Juvenile Idiopathic Arthritis and Systemic Juvenile Idiopathic Arthritis, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Contact Sharat Chandra, MD (513-636-5917, Sharat.Chandra@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival at 1 year (time frame: 1-year post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.