An Extension Long-Term Study of RoActemra/Actemra (Tocilizumab) in Patients With Polyarticular Juvenile Idiopathic Arthritis Who Completed The WA19977 Study

Conditions

• Juvenile Idiopathic Arthritis

Eligibility Criteria

Sex

ALL

Age

9 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

• tocilizumab [RoActemra/Actemra] — DRUG
  8 mg/kg or 10 mg/kg iv every 4 weeks, 104 weeks

Study Details

This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 core study. Patients aged 9-18 years with at least JIA ACR30 clinical response to RoActemra/Actemra in the core study will be eligible to receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.

Key Dates

Start date

Mar 31, 2013

Status verified

May 2016

Primary completion

Nov 30, 2015

Completion

Nov 30, 2015

Study Design

Enrollment

11 participants (actual)

Primary purpose

TREATMENT

Arms

• Experimental: RoActemra/Actemra

Primary Outcome Measure

Long-term safety: Incidence of adverse events [ Time Frame: approximately 3 years ]

Related Studies

• Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions
  Recruiting · Children's National Research Institute · Washington D.C., District of Columbia
• Study of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Moves Through the Body of Pediatric and Adolescent Participants With Active Systemic Juvenile Idiopathic Arthritis.
  PHASE3 · Recruiting · AbbVie · Phoenix, Arizona
• Pain in Juvenile Arthritis
  Recruiting · Washington University School of Medicine · St Louis, Missouri