MAS825 treatment for children and adults with Still's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II interventional trial gives MAS825 to pediatric and adult participants with active Still's disease to measure clinical benefit and safety. Participants must have elevated CRP or ferritin and at least one clinical sign such as fever, rash, arthritis, serositis, or macrophage activation syndrome, and require glucocorticoids. Key outcomes include changes in symptoms, inflammatory markers, glucocorticoid use, and adverse events. The trial is sponsored by Novartis and enrolling at sites in Cincinnati, Portland, and Montreal.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 1 with a diagnosis of Still's Disease
* Active diseases defined as:
* CRP or ferritin levels greater than ULN, and any of:

  * Fever ≥ 38°C attributed to Still's Disease activity and documented for a number of days prior to Day 1 or
  * Rash attributed to Still's Disease activity or
  * Musculoskeletal involvement: arthritis in a number of joints per ACP criteria for active joint or
  * Serositis or
  * Macrophage activation syndrome activity as defined by ferritin levels and at least one of: platelet count, a biomarker or fibrinogen levels attributed to Still's Disease activity by the investigator
* Intolerance or inadequate response to available biologic therapy

Exclusion Criteria:

* Patients out of weight range
* Ongoing or previous treatment with immunomodulatory drugs

  * A limited number of Still's Disease patients that have previously received MAS825 through a managed access program are permitted on the study
* Glucocorticoid dose exceeding a set limit
* Any conditions or significant medical problems which places the patient at unacceptable risk for MAS825 therapy

  * Still's disease patients with evidence of macrophage activation syndrome are permitted in the study
  * Still's Disease patients with evidence of interstitial lung disease including those requiring supplemental oxygen therapy are permitted in the study
* History of ongoing, chronic or possibly recurrent infection (e.g. HIV, TB, HCV, HBV) and/or symptoms and signs of clinically significant active bacterial, fungal or viral infections
* Live vaccinations within a set time prior to MAS825 treatment. Live vaccines are prohibited up to several months following the last dose
* History of malignancy of any organ system, including post-transplant lymphoproliferative disorder, treated or untreated, within a number of years, regardless of whether there is evidence of local recurrence and metastases
* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or to any of the excipients
* Pregnant or breastfeeding women
* Women of child-bearing potential who do not agree to comply with required contraceptive use

Other protocol-defined inclusion/exclusion criteria may apply.

Where it's running

• Legacy Emanuel Research Hosp Portland
  Portland, Oregon, United States Recruiting
• University of Utah
  Salt Lake City, Utah, United States Recruiting
• Novartis Investigative Site
  Toronto, Ontario, Canada Recruiting
• Novartis Investigative Site
  Bordeaux, France Recruiting
• Novartis Investigative Site
  Bron, France Recruiting
• Novartis Investigative Site
  Le Kremlin-Bicêtre, France Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Canakinumab use in FMF and Still's disease patients across real-world care

  This real-world study looks at how people with FMF or Still's disease who were treated with canakinumab fare over at least 6 months.

  Recruiting Novartis · Basel · NCT07517250

• Imaging in Inflammatory Heart Diseases linked to autoimmune disorders

  This study tests how well multimodality imaging (CMR, echocardiography, and PET) detects inflammation in people with suspected inflammatory heart or autoimmune rheumatic diseases.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris · NCT07077304

• Observational cohort for Adult Onset Still Disease and Systemic onset Juvenile Idiopathic Arthritis

  This study is collecting information from adults and children with Adult Onset Still Disease and Systemic onset Juvenile Idiopathic Arthritis to better understand their symptoms and how the diseases progress.

  Recruiting Institut National de la Santé Et de la Recherche Médicale, France · Paris, Île-de-France Region · NCT05927454

• Registry for hereditary autoinflammatory diseases

  This study is collecting information about hereditary autoinflammatory diseases to see how they affect patients of different ages and genders, with the goal of improving treatment and care for everyone affected.

  Recruiting at 112 sites University of Siena · Algiers and 111 other locations · NCT05200715

• Understanding the causes and effects of systemic juvenile idiopathic arthritis and adult-onset Still's disease

  This study is trying to understand what causes systemic juvenile idiopathic arthritis and adult-onset Still's disease by looking at the health history and genetics of children and adults with these conditions.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT03510442

• Glycosylated ferritin testing for adult Still's disease and macrophage activation syndrome

  This study will test whether measuring the glycosylated portion of ferritin helps diagnose adult-onset Still's disease and macrophage activation syndrome in adults with high ferritin or suspected sepsis.

  Recruiting Brugmann University Hospital · Brussels · NCT02143986

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.