Phase 3 Uveitis Trial, Completed NCT03841357 Sponsor: Duke University Condition: Uveitis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial looked at whether a medicine called abatacept (given alongside usual care) might influence the course of a form of childhood arthritis compared to usual care alone. The trial ran across two parts. In Part I, 20 participants received abatacept plus usual care and 20 received usual care only. In Part II, 81 participants received abatacept plus usual care and 662 received usual care only — making a total of 783 participants across both parts. The trial tracked participants for roughly 14 months and measured several things: whether they developed widespread joint involvement (5 or more active joints, called polyarthritis), eye inflammation (uveitis), or needed to start stronger medicines such as steroids or other disease-modifying drugs. The reported data shows the following numbers for the combined (pooled) results across both parts of the trial. Out of 101 participants who received abatacept plus usual care, 54 reached at least one of the main tracked events, compared with 259 out of 682 participants in the usual care group. Looking at the individual tracked events in the pooled groups: polyarthritis was recorded in 22 abatacept participants versus 55 in the usual care group; uveitis was recorded in 5 abatacept participants versus 31 in the usual care group; and starting stronger systemic medicines was recorded in 52 abatacept participants versus 243 in the usual care group. For the secondary measures, the reported data shows that 48 participants in the abatacept group and 264 in the usual care group were recorded as having clinically inactive disease or remission at some point during the study. Disease spread (developing polyarthritis or uveitis) was recorded in 18 abatacept participants and 73 usual care participants across the pooled groups. It is important to note that the two groups were very different in size, so the raw numbers alone do not tell the full story — the groups had notably different numbers of participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Uveitis Trial, Completed

NCT03841357
Completed Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 2 and 16.5 years old
  • A pediatric rheumatologist (a children's joint specialist) has diagnosed you with Juvenile Idiopathic Arthritis (JIA) within the past 6 months
  • The arthritis has affected 4 or fewer joints from when symptoms started up until joining the study
  • You are already enrolled in, or willing to enroll in, a database called the CARRA Registry
  • If you are able to become pregnant, you must agree to avoid pregnancy during the study — either by not having sex or by using an effective form of birth control, continuing for at least 66 days after the last dose of study medication
  • You weigh at least 50 kg (110 lbs) — for participants joining through Canadian study sites only

Who may not be able to join:

  • You have a specific type of JIA called Systemic JIA (confirm with trial site)
  • You have inflammation in the joints of your lower spine or pelvis (sacroiliitis), either based on symptoms or imaging
  • You have inflammatory bowel disease (such as Crohn's disease or ulcerative colitis)
  • You have a current or past history of psoriasis (a skin condition)
  • You have a current or past history of uveitis (inflammation inside the eye)
  • You have previously taken any prescription medications for JIA, such as DMARDs or biologic drugs (confirm with trial site)
  • You are currently taking, or have taken within the last 30 days, steroid medications by mouth or injection — though a short course of oral prednisone of 14 days or less is allowed
  • You have a history of liver disease, either long-term or active
  • You have a kidney disease or disorder, either long-term or sudden onset
  • Certain blood test results from within the past 2 months are outside the normal range for liver or kidney function, or another result that your doctor considers significant (confirm with trial site)
  • Your doctor feels that a medical or psychological condition, or a lab result, makes you unsuitable for the study
  • You have taken part in another clinical trial within the last 30 days
  • You have tested positive for HIV
  • You have received a live virus vaccine (such as MMR or chickenpox vaccine) within 1 month before the start of the study
  • You have ever tested positive for tuberculosis (TB) on a skin test or blood test
  • You are pregnant, breastfeeding, or plan to breastfeed during the study
  • You are expected to move to a rheumatology center or adult specialist that is not part of this study within the next 12 months
  • You have an active cancer or a history of cancer of any type
  • You have an ongoing infection, or have had a serious infection requiring hospital treatment or IV antibiotics within the last 30 days, or oral antibiotics within the last 14 days
  • Your primary language is not English or Spanish
  • You have tested positive for Hepatitis B
  • You weigh less than 10 kg (about 22 lbs)
  • You currently have symptoms of COVID-19 or have recently been exposed to someone with COVID-19 — though you may be able to re-apply once there is no longer concern about active infection

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Completed
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
29 October 2019
Est. completion
22 January 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Composite of All Primary Endpoints; Number of Participants With Polyarthritis; Number of Participants With Uveitis; Number of Participants With Systemic Medications

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov