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Juvenile Idiopathic Arthritis (JIA)

Trial

Clinical Trial Title

Long-Term Safety Study Of Tofacinib In Patients With Juvenile Idiopathic Arthritis

Trial Status

Open to Enrollment

Start Date

April 14, 2014

Trial Type

Pediatric Rheumatology

Specific Condition

Juvenile Idiopathic Arthritis

Description

This study is being done to examine the long-term safety and efficacy of an investigational drug (CP-690,550) in children with Juvenile Idiopathic Arthritis (JIA).  This is an extension of a previous treatment study and subjects can only participate if they were in the previous study.

 

Subjects will be in this study for up to 10 years.  The total duration of an individual subject’s participation may vary depending upon when they entered the trial. 

 

Subjects will receive the medication in either liquid or tablet form, depending on his/her age and weight.

  • If a subject is less than 12 years old or under 40kg (88 lbs.), the study medicine will be a liquid that he/she can drink;
  • If a subject is older than 12 years old or greater than 40kg (88lbs.), the study medicine will be a tablet.  If the subject is unable to swallow a pill, they will be able to take the medicine as a liquid.

Eligibility Criteria

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

 

Inclusion Criteria:

  • Pediatric patients with JIA aged from 2 to less than 18 years who met entry criteria for the qualifying /index study and in the opinion of the investigator have sufficient evidence of RA disease activity to warrant use of CP-690,550 as a DMARD.
  • Patients turning 18 years of age during participation in the qualifying /index study or subsequently will be eligible for participation in this study.

IRB Number

10626

Principal Investigator Name

Daniel Kingsbury, MD

Contact Name

Kristin Hickey

Phone

503-413-5447

Contact Fax

503-413-3543

Contact E-Mail

khickey@lhs.org

Last Updated: Wednesday, January 27, 2021 12:09:20 PM