Tocilizumab in the Management of Juvenile Idiopathic Arthritis Associated Uveitis

NCT01603355 | Terminated Phase 1 Results

• 1 other identifier: e8343
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are doing this research study to see if tocilizumab (Actemra) is safe and effective when used for severe or refractory non-infectious uveitis. Uveitis is an inflammation of the eye that is caused by the body's immune system reacting against the eye tissues.

Conditions

Juvenile Idiopathic Arthritis Associated Uveitis

Keywords

JIA

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Control of Ocular Inflammation

  control of anterior chamber cell in both eyes at week 16 to a level of trace or less (SUN criteria) without an increase in any immunosuppressive treatment and while using prednisolone acetate topically no more than 2 times per day

  16 Weeks

Study Arms (1)

Tocilizumab

EXPERIMENTAL

Drug: Tocilizumab

Interventions

Tocilizumab DRUG

Intravenous tocilizumab: Patients less than 30 kg weight:10 mg per kg every 4 weeks Patients at or above 30 kg weight: 8 mg per kg every 4 weeks

Also known as: Actemra

Tocilizumab

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects with Juvenile Idiopathic Arthritis
• Subjects with vision-threatening autoimmune uveitis.
• Failure to respond to methotrexate or at least one other systemic immunosuppressive or intolerance to such medications due to side effects. Failure to respond includes presence of one plus or greater anterior chamber cell in both eyes; need for topical corticosteroid four times or more in either eye; ocular hypertension or glaucoma attributable to the topical corticosteroid.
• Subjects with bilateral disease.
• If subjects are on oral corticosteroids, the dosage must be stable for 2 weeks prior to baseline and not exceed 10 mg per day or 2mg/kg/day (whichever is less) of prednisone or its equivalent. Subjects must be willing to agree to not alter the dosage of oral steroids during the first 16 weeks of the trial.
• Must have a chest radiograph within 3 months prior to enrollment with no evidence of malignancy, infection or fibrosis.
• Parent or guardian must understand and voluntarily sign an informed consent form.
• Pediatric subjects of either gender 2-17 years at time of consent.

You may not qualify if:

• Inability of parent or guardian to provide voluntary consent
• Major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 12 months following randomization.
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
• Pregnant or breastfeeding
• Current liver disease, as determined by the Principal Investigator on the basis of history or serum studies
• History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies including tocilizumab.
• Evidence of significant uncontrolled concomitant diseases such as nervous system, renal, hepatic (patients with prior history of ALT elevation will not be excluded), endocrine, or gastrointestinal (GI) disorders, which in the Investigator's opinion, would preclude patient participation.
• Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids.
• Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
• History of active mycobacterial infection with any species (including Mycobacterium tuberculosis) within 2 years prior to screening visit. Subjects with Mycobacterium tuberculosis infection more than 2 years prior to screening visit are allowed if successful treatment was completed at least 2 years prior to randomization and is documented and available for verification.
• Immunization with a live/attenuated vaccine within 4 weeks prior to baseline
• Latent Mycobacterium tuberculosis infection as indicated by a positive Purified Protein Derivative \[PPD\] skin test. Subjects with a positive PPD skin test and documented completion of treatment for latent TB are eligible. Subjects with a positive PPD skin test and not treated or no documentation of completion of treatment are ineligible.
• If QuantiFERON® test is performed instead of the PPD test, only those with a negative QuantiFERON® test are allowed in the study.
• History of incompletely treated Mycobacterium tuberculosis infection as indicated by
• Subject's medical records documenting incomplete treatment for Mycobacterium tuberculosis

Sponsors & Collaborators

• Eric B. Suhler: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Interventions

tocilizumab

Results Point of Contact

• Title: Dr. Eric Suhler
• Organization: Oregon Health & Science University

suhlere@ohsu.edu

503-494-5023

Study Officials

• Eric B Suhler, MD,MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• James T Rosenbaum, MD

  Oregon Health and Science University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2012
• First Posted: May 22, 2012
• Study Start: November 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: January 14, 2019
• Results First Posted: November 27, 2018

Record last verified: 2019-01

Locations

US (1)