A Study to Evaluate Pharmacokinetics and Safety of Tocilizumab (RoActemra/Actemra) in Participants Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis (sJIA)

Completed · Phase 1

Conditions studied: Juvenile Idiopathic Arthritis

In brief

This is a multi-center, open-label single-arm study to investigate the pharmacokinetics and safety of tocilizumab (RoActemra/Actemra) in participants less than 2 years old with active sJIA. Participants will receive tocilizumab infusions every 2 weeks. The anticipated time on study treatment is 12 weeks (Main evaluation period). Participants will have the option to continue tocilizumab treatment until participant reaches 2 years of age or up to one year from baseline, whichever is longer. An optional extension period will follow the main evaluation period.

Key facts

Study ID: NCT01455701
Run by: Hoffmann-La Roche
People needed: 11
Starts: 2012-10-26
Expected to finish: 2017-07-13
Last updated by the study team: 2019-11-04

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Fulfils international league of associations for rheumatology (ILAR) classification criteria for sJIA
Duration of sJIA symptoms lasting for at least 1 months subsequent to diagnosis of sJIA
Presence of active disease as determined by the presence of:
Greater than or equal to (>=) 2 active joints at screening and baseline, with at least 14 consecutive days of temperature recordings, which may include the presence or absence of fever (>=38 degree Celsius) during the time between screening and baseline; or
>=2 active joints at screening and baseline, with a fever >=38 degree Celsius for at least 5 consecutive days during the time between screening and baseline; under these circumstances a participant does not need to complete a full 14 days of temperature diary entries to meet this inclusion criteria
Not currently receiving corticosteroids (CS) or if taking oral CS like prednisone or equivalent, the dose should be less than or equal to (<=) 1 milligram per kilogram per day (mg/kg/day) and the dose has remained stable for at least 2 weeks prior to baseline
Not currently receiving methotrexate (MTX) or if taking MTX (together with either folic acid or folinic acid according to local standard-of-care), the dose has remained stable or has been discontinued for at least 4 weeks prior to baseline
Not currently receiving non-steroidal anti-inflammatory drugs (NSAIDs) or if taking NSAID, the dose has remained stable or has been discontinued for at least 2 weeks prior to baseline
If the participants has received previous treatment with any of the following biologic agents, these must have been discontinued according to the following timelines prior to the baseline visit and are not permitted during the study:
Etanercept must have been discontinued within >= 2 weeks prior to baseline
Anakinra must have been discontinued within >= 4 days prior to baseline
Abatacept must have been discontinued within >= 12 weeks prior to baseline
Infliximab or adalimumab must have been discontinued within >= 8 weeks prior to baseline
Canakinumab must have been discontinued within >= 20 weeks prior to baseline
Rilonacept must have been discontinued within >= 6 weeks prior to baseline
Golimumab must have been discontinued within >= 10 weeks prior to baseline
Certrolizumab pegol must have been discontinued within >= 10 weeks prior to baseline
History of inadequate clinical response (in the opinion of the treating physician) to NSAIDs and CS

You may not qualify if…

General Exclusion Criteria:
Any autoimmune, rheumatic disease or overlap syndrome other than sJIA
Not fully recovered from recent surgery or less than 6 weeks since surgery, at the time of screening visit; or planned surgery during the study (except for myringotomy surgery, which is permitted)
General Safety Exclusion Criteria:
Any significant concurrent medical or surgical condition which would jeopardize the participant's safety or ability to complete the trial
History of significant allergic or infusion reactions to prior biologic therapy or to any of the excipients listed in tocilizumab product labelling documents
Inborn conditions characterized by a compromised immune system
Known human immunodeficiency virus (HIV) infection or other acquired forms of immune compromise
Evidence of serious uncontrolled concomitant diseases including but not limited to the nervous system, renal, hepatic or endocrine systems
Asthma for which the participant has required the use of oral or parenteral corticosteroids for >=2 weeks within 6 months prior to baseline visit
Any active acute, subacute, chronic or recurrent bacterial, viral or systemic fungal infection
History of atypical tuberculosis (TB)
Active TB requiring treatment at any point prior to screening visit
Positive TB test result at screen, unless treated with anti-TB therapy for at least 4 weeks prior to receiving study medication and chest radiograph is negative for active TB within 6 months of screening visit consistent with local practice
Any major episode of infection requiring hospitalization or treatment during screening or treatment with IV antibiotics completing within 4 weeks of the screening visit or oral antibiotics completing within 2 weeks of the screening visit
History of reactivation or new onset of a systemic infection such as herpes zoster or Epstein Barr virus within 2 months of the screening visit
History of hepatitis B or hepatitis C infection
Chronic hepatitis - viral or autoimmune
Significant cardiac or pulmonary disease
History or concurrent serious gastrointestinal disorders such as ulcer or inflammatory bowel disease, ulcerative colitis or other symptomatic lower gastrointestinal conditions, including ulcer and perforation
History of or current cancer or lymphoma
History of macrophage activation syndrome (MAS) within 3 months prior to the screening visit
Uncontrolled diabetes mellitus with elevated hemoglobin A1c (HbA1c) as defined by age-specific standards
Excluded Previous or Concomitant Therapy:
Participation in another interventional clinical trial within the past 30 days or 5 serum half-lives of the investigative medication, whichever is longer

Where it is running

Children's National Medical Center; Pediatric Rheumatology — Washington D.C., District of Columbia, United States
The University of Chicago;Department of Pediatrics — Chicago, Illinois, United States
University of Louisville Research Foundation, Inc; Kosair Charities Pediatric Clinical Research Unit — Louisville, Kentucky, United States
The Floating Hospital for Children at Tufts Medical Center — Boston, Massachusetts, United States
Children's Hospital Boston Pediatric Medicine — Boston, Massachusetts, United States
Children's Speciality Center of Nevada — Las Vegas, Nevada, United States
Hackensack University Medical Center; Pediatric Rheumatology — Hackensack, New Jersey, United States
Cincinnati Children'S Hospital Medical Center; Division of Rheumatology — Cincinnati, Ohio, United States
Children's Hospital Of Pittsburgh — Pittsburgh, Pennsylvania, United States
Hospital Gral de Niños Pedro Elizalde — Buenos Aires, Argentina
UZ Gent — Ghent, Belgium
UZ Leuven Gasthuisberg — Leuven, Belgium
Alberta Children'S Hospital — Calgary, Alberta, Canada
Hospital For Sick Children — Toronto, Ontario, Canada
McGill University; Montreal Children's Hospital; Inflammatory, Autoimmune & Bone — Montreal, Quebec, Canada
Klinik Bremen-Mitte; Prof. Hess-Kinderklinik — Bremen, Germany
Semmelweis University; 2nd Department of Paediatrics — Budapest, Hungary
Uniwersytecki Szpital Kliniczny Nr 4 im. M. Konopnickiej; Oddz. Kardiolog. i Reumatolog. dla Dzieci — Lodz, Poland
Uniwersytecki Szpital Dzieciecy w Lublinie; Oddzial Pediatrii, Chorob Pluc i Reumatologii — Lublin, Poland
Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica — Valencia, Spain

Full record on ClinicalTrials.gov

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