Single Patient Use of Tocilizumab in Systemic Onset Juvenile Idiopathic Arthritis

Conditions

• Arthritis, Juvenile Rheumatoid
• Still's Disease, Juvenile Onset

Eligibility Criteria

Sex

ALL

Age

2 Years - 16 Years

Healthy Volunteers

Not accepted

Interventions

• tocilizumab — BIOLOGICAL
  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.

Study Details

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.

Key Dates

Start date

Mar 31, 2009

Status verified

May 2017

Primary completion

Nov 30, 2009

Completion

Jun 30, 2010

Study Design

Enrollment

1 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Tocilizumab
  Single arm study - treatment only

Primary Outcome Measure

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) ]

Locations (1)

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