An interventional study of tocilizumab in Arthritis, Juvenile Rheumatoid and Still's Disease, Juvenile Onset, sponsored by Tufts Medical Center. Terminated at 1 site in United States. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2017-05-15.
Sponsored by Tufts Medical Center · Not applicable, Interventional, and Treatment
The purpose of this study is to see if tocilizumab is safe and effective for treating systemic onset Juvenile Idiopathic Arthritis (soJIA). Another purpose is to see if tocilizumab helps reduce the amount of steroids (prednisone) needed to control symptoms of soJIA.
Systemic onset Juvenile Idiopathic Arthritis (soJIA) is a type of arthritis (inflammation of the joints) that occurs with other symptoms including fever, swollen lymph nodes (glands), rash, and body aches. Because soJIA can be difficult to treat, children with soJIA can have severe problems from long-term use of steroids (prednisone). These problems include low bone density (weak bones), fractures, failure to grow properly, and large weight gain. The arthritis that occurs in soJIA often causes damage to many joints. This can make it hard to move around or do basic tasks like dressing. Also, a life-threatening illness called Macrophage Activation Syndrome (MAS) can occur when starting, stopping, or changing drugs that are used to treat soJIA.
SoJIA can be hard to treat and many children with soJIA do not respond to drugs that work for other kinds of arthritis. Research doctors have studied a chemical signal called IL-6 that the body uses to manage inflammation. This signal has been found to be very high in patients with active soJIA. A drug called tocilizumab (TCZ) has been designed to block IL-6. For about 6 years, TCZ has been tested in Japan for treating soJIA. It is now being tested in studies in the United States. These studies can have very strict rules for enrolling patients. This trial is a single-patient research study for a subject who otherwise does not meet the rules for enrollment in ongoing trials.
359 studies on the registry are indexed under Arthritis, Juvenile; 95 are open to participants now.
This study's enrollment of 1 is below the median of 50 across 229 interventional studies indexed under Arthritis, Juvenile.
Browse Arthritis, Juvenile studies →Tufts Medical Center is the lead sponsor of 200 studies on the registry; 29 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 16 (52%) have results posted.
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Exclusion Criteria:
Single arm study - treatment only
Biological: tocilizumab
Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks. Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16.
Also known as: Actemra, RoACTEMRA, MRA
Efficacy of Tocilizumab as Defined by Presence of an Equal to or Greater Than 30% Improvement in JIA Core Set (i.e. ACR JIA30 Response)
Time frame: At week 12 of treatment versus week 0 (pretreatment)
Efficacy of Tocilizumab as Defined by Reduction of Oral Prednisone Dose by at Least 20%, or to Less Than 0.5mg/kg/Day, Whichever is of Lesser Daily Dose, While Maintaining an ACR JIA30 Response
Time frame: At weeks 12 and 16 of treatment versus week 0 (pretreatment)
Number of Participants With at Least One Adverse Event
To evaluate the safety of tocilizumab administration in this subject
Time frame: Ongoing, throughout 24 month study period
Measurement of Laboratory Parameters of Active Disease, Specifically C-reactive Protein, Hemoglobin, Platelets, White Blood Cell Count, Ferritin, Immunoglobulins.
To assess normalization of laboratory parameters of active disease, specifically C-reactive protein, hemoglobin, platelets, white blood cell
Time frame: At weeks 8, 12, and 16 of treatment, and every 8-12 weeks thereafter
Measurement of Sustained Clinical Response to Tocilizumab, Including Active Joint Count, Joints With Limited Range of Motion, and Absence of Fever or Rash.
To assess sustained clinical response to tocilizumab, including active joint count, joints with limited range of motion, and absence of fever
Time frame: At weeks 8, 12, 16 of treatment, and every 8 weeks thereafter
| Milestone | Tocilizumab |
|---|---|
| Started | 1 |
| Completed | 0 |
| Not completed | 1 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
To evaluate the safety of tocilizumab administration in this subject
| Participants | Tocilizumab |
|---|---|
| Number of Participants With at Least One Adverse Event | 1 |
To assess normalization of laboratory parameters of active disease, specifically C-reactive protein, hemoglobin, platelets, white blood cell
No measurements were reported for this outcome.
To assess sustained clinical response to tocilizumab, including active joint count, joints with limited range of motion, and absence of fever
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tocilizumab | — | 1/1 (100%) | 0/1 (0%) |
| Event | Tocilizumab |
|---|---|
| Hyperintensities of unclear etiology on brain MRI. Follow up revealed no progression.Nervous system disorders | 1/1 |
| Age, Categorical(Participants) | Tocilizumab |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Tocilizumab |
|---|---|
| Female | 0 |
| Male | 1 |
| Region of Enrollment(participants) | Tocilizumab |
|---|---|
| United States | 1 |
This study is terminated, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tocilizumab