Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA) (Limit-JIA)
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ClinicalTrials.gov Identifier: NCT03841357 |
Recruitment Status :
Recruiting
First Posted : February 15, 2019
Last Update Posted : September 1, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Juvenile Idiopathic Arthritis | Drug: Abatacept Injection Other: Usual Care | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 306 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Open Label, Multi-Center, Phase 3 Efficacy Study of Sub-Q Abatacept in Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA) |
Actual Study Start Date : | October 29, 2019 |
Estimated Primary Completion Date : | December 15, 2022 |
Estimated Study Completion Date : | December 15, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Abatacept and Usual Care
Weekly abatacept injection at standard dosing for weight plus usual care with steroid joint injection and non-steroidal anti-inflammatory drugs per the discretion of the treating provider
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Drug: Abatacept Injection
Supplied as a weekly injection via a pre-filled syringe
Other Name: Orencia Other: Usual Care Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs |
Active Comparator: Usual Care
Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider
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Other: Usual Care
Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs |
- Change in Joint Count by Physician Exam [ Time Frame: Baseline, up to 18 months ]The number of affected joints involved at protocol specified visits by physician exam.
- Change in Number of participants with active anterior uveitis [ Time Frame: Baseline, up to 18 months ]The presence of active anterior uveitis, defined according to the Standardization of Uveitis Nomenclature for Reporting Clinical Data (SUN criteria) as the presence of one or more cells in each 1mm x 1mm slit beam field,84 will be assessed at standard of care ophthalmology visits
- Change in pain score as measured by PROMIS (patient reported outcome measurement system) [ Time Frame: Baseline, up to 18 months ]We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
- Change in fatigue level as measured by PROMIS [ Time Frame: Baseline, up to 18 months ]We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
- Change in functional ability by PROMIS [ Time Frame: Baseline, up to 18 months ]We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
- Change in anxiety by PROMIS [ Time Frame: Baseline, up to 18 months ]We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
- Change in depression by PROMIS [ Time Frame: Baseline, up to 18 months ]We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
- Change in global health by PROMIS [ Time Frame: Baseline, up to 18 months ]Global health is defined as overall well being; We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
- Change in family impact by PedsQL [ Time Frame: Baseline, up to 18 months ]The PedsQL (Pediatric Quality of Life InventoryTM) Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions.
- Change in medications side effects by JAMAR [ Time Frame: Baseline, up to 18 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 2 Years to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
To be eligible for this trial, participants must meet all of the following criteria in order to be include in the study:
- Age ≥ 2 years old and ≤16.5 years old
- Clinical diagnosis of JIA by a pediatric rheumatologist within the past 6 months
- Arthritis affecting ≤4 joints between disease onset and randomization
- Clinically active arthritis of at least 1 joint at the time of enrollment ¹
- Enrollment in the CARRA Registry
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Participants of childbearing potential must agree to remain abstinent or agree to use an effective and medically acceptable form of birth control from the time of written or verbal assent to at least 66 days after taking the last dose of study drug.
- Enrollment is defined as having signed consent to participate in the Limit-JIA study.
The presence of any of the following will exclude a study participant from inclusion in the study:
- Systemic JIA as defined by 2004 ILAR criteria1
- Sacroiliitis (clinical or radiographic)
- Inflammatory bowel disease (IBD)
- History of psoriasis or currently active psoriasis
- History of uveitis or currently active uveitis
- Prior treatment with systemic medication(s) for JIA (e.g. one or more of the following: DMARD or biologic medication)
- Current or previous (within 30 days of enrollment) treatment with systemic glucocorticoids
- History of active or chronic liver disease
- Chronic or acute renal disorder
- AST (SGOT), ALT (SGPT) or BUN >2 x ULN (upper limit of normal) or creatinine >1.5 mg/dL or any other laboratory abnormality considered by the examining physician to be clinically significant within 2 months of the randomization visit
- Presence of any medical or psychological condition or laboratory result which would make the participant, in the opinion of the investigator, unsuitable for the study
- Participation in another concurrent clinical interventional study within 30 days of randomization
- Known positive human immunodeficiency virus (HIV)
- Received a live virus vaccine within 1 month of the baseline visit
- Current or prior positive Purified Protein Derivative (PPD) test or Quantiferon Gold TB
- Pregnant, breast feeding, or planned breast feeding during the study duration
- Planned transfer to non-participating pediatric rheumatology center or adult rheumatologist in the next 12 months
- Active malignancy of any type or history of malignancy
- Chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 30 days or oral antibiotics within 14 days prior to screening
- Primary language other than English or Spanish
- Positive for Hepatitis B surface antigen or core antibody
- <10 Kg in weight

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): NCT03841357
Contact: Valarie Morrow | 9197248931 | valarie.morrow@duke.edu |
United States, California | |
University of California at San Francisco Medical Center | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Emily von Scheven, MD | |
United States, Illinois | |
Children's Memorial Hospital/ Ann & Robert H Lurie Children's Hospital | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Marisa Klein-Gitelman, MD | |
United States, Indiana | |
Riley Hospital for Children at Indiana University Health | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Stacey Tarvin, MD | |
United States, Minnesota | |
University of Minnesota; Children's Hospital and Clinics of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55454 | |
Contact: Richard Vehe, MD | |
United States, New Jersey | |
Hackensack University Medical Center | Recruiting |
Hackensack, New Jersey, United States, 07601 | |
Contact: Sivia Lapidus, MD | |
The Pediatric Specialty Center at Saint Barnabas/RWJ Barnabas Health | Recruiting |
West Orange, New Jersey, United States, 07052 | |
Contact: Elizabeth Chalom, MD | |
United States, New York | |
Children's Hospital at Montefiore/ Albert Einstein University Hospital | Recruiting |
Bronx, New York, United States, 10461 | |
Contact: Dawn Wahezi, MD | |
United States, North Carolina | |
University of North Carolina | Recruiting |
Chapel Hill, North Carolina, United States, 27514 | |
Contact: Eveline Wu, MD | |
Levine Children's Hospital/ Carolina Medical Center | Recruiting |
Charlotte, North Carolina, United States, 28203 | |
Contact: Thomas Griffin, MD | |
Duke Children's Hospital and Health Center | Recruiting |
Durham, North Carolina, United States, 27705 | |
Contact: Laura Schanberg, MD 919-684-6601 | |
Wake Forest Baptist Hospital | Recruiting |
Winston-Salem, North Carolina, United States, 27157 | |
Contact: Alysha Taxter, MD | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | Recruiting |
Cincinnati, Ohio, United States, 45229 | |
Contact: Sheila Angeles-Han, MD | |
United States, Washington | |
Seattle Children's Hospital | Recruiting |
Seattle, Washington, United States, 98105 | |
Contact: Sarah Ringold, MD |
Principal Investigator: | Laura Schanberg, MD | Duke University | |
Principal Investigator: | Stephen Balevic, MD | Duke University |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT03841357 |
Other Study ID Numbers: |
Pro00100523 |
First Posted: | February 15, 2019 Key Record Dates |
Last Update Posted: | September 1, 2020 |
Last Verified: | May 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Polyarthritis abatacept uveitis prevention |
Arthritis Arthritis, Juvenile Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases |
Immune System Diseases Abatacept Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |