Juvenile Idiopathic Arthritis Associated UveitisPhase 1/2NCT01603355

Tocilizumab in the Management of Juvenile Idiopathic Arthritis Associated Uveitis

A Phase 1/2 study testing Tocilizumab in people with Juvenile Idiopathic Arthritis Associated Uveitis, run by Eric B. Suhler at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 2 to 17 years
Conditions the study is for: Juvenile Idiopathic Arthritis Associated Uveitis
What is being tested?: Tocilizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteUnited States
Study dates: Nov 2013to Feb 2016
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

Show all 41Show fewer

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
Subject's self-reported history of incomplete treatment for Mycobacterium tuberculosis
History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years) or recurrent viral, fungal, mycobacterial, or other infections (including but not limited to atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of the nail beds)
Clinically significant abnormality on the chest x-ray (CXR) at screening. Chest x-rays performed within 3 months prior to start of study drug are acceptable.
Use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer)
History of congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency [CVID])
Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening
History of Human Immunodeficiency Virus (HIV) infection
Antibodies to Hepatitis C at screening
Malignancy or history of malignancy (except for treated [ie, cured] basal-cell skin carcinomas > 3 years prior to screening)
Have multiple sclerosis or other central demyelinating disorder.
Presence of a transplanted organ (with the exception of a corneal transplant performed > 3 months prior to enrollment).
History of substance abuse (drug or alcohol) within the previous 3 years, history of noncompliance to medical regimens, or other condition/circumstance that could interfere with the subject's adherence to protocol requirements.
Previous or current use of an alkylating agent (e.g. chlorambucil or cyclophosphamide).
Treatment with etoposide (VP16) within 3 months prior to the baseline visit.
Administration of intravenous immunoglobulin for the treatment of active polyarticular disease within 4 weeks prior to the baseline visit.
Previous treatment with any cell depleting therapies, including investigational agents (e.g. anti-CD19 and anti-CD20).
Prior stem cell transplant at any time.
TNF -blocker use within the 8-weeks prior to enrollment (Infliximab use within 10 weeks prior to enrollment).
Laboratory Exclusion criteria (at screening):
Serum creatinine >1.5 ULN (upper limit of normal for age and sex);
AST or ALT > 1.5 ULN (upper limit of normal for age and sex);
Total bilirubin > 1.3 mg/dL (> 23 umol/L);
Platelet count < 150 x 103/μL (< 150,000/mm3);
Hemoglobin < 9.0 g/dL (< 3.7 mmol/L);
WBC count < 5,000/mm3 (< 5.0 x 109/L);
Neutrophil count < 2,500/ mm3 (< 2.5 x 109/L)

Trial locations and contacts

1 site in 1 country.

United States1 site

Oregon Health & Science University
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: An Open-label Trial to Assess the Efficacy and Safety of Tocilizumab in the Management of Juvenile Idiopathic Arthritis Associated Vision-threatening Uveitis That is Refractory to Other Modes of Systemic Immunosuppression

Conditions: Juvenile Idiopathic Arthritis Associated Uveitis
Being tested: Tocilizumab
Keywords: JIA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TocilizumabDrug
Also called Actemra
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

Study groups in NCT01603355
Study group	Role	What they receive
Tocilizumab	Experimental	Not described Receives: Drug: Tocilizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 16 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2013Feb 2016

First posted22 May 2012 (estimated)
Study startNov 2013
Primary completionFeb 2016
Study completionFeb 2016

Why it stopped: insufficient enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Juvenile Idiopathic Arthritis Associated UveitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01603355
Sponsor's protocol ID: e8343
Status last verified: Jan 2019
First submitted: 18 May 2012
Last updated: 14 Jan 2019
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research
Pericarditis, Tako-TSUBO Cardiomyopathy
Not yet recruitingPhase 4
Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial
Juvenile Idiopathic Arthritis Associated Uveitis, Uveitis, Anterior
RecruitingObservational study
EACVI Study on Multimodality Cardiovascular Imaging of Inflammatory Cardiovascular Diseases
Myocarditis, ANCA Associated Vasculitis
Active, not recruitingPhase 3
A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis
Uveitis

All Juvenile Idiopathic Arthritis Associated Uveitis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Trial to Assess the Efficacy and Safety of Tocilizumab in the Management of Juvenile Idiopathic Arthritis Associated Vision-threatening Uveitis That is Refractory to Other Modes of Systemic Immunosuppression
ClinicalTrials.gov ID: NCT01603355
Acronym / sponsor ID: e8343
Conditions: Juvenile Idiopathic Arthritis Associated Uveitis
Keywords: JIA
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: insufficient enrollment
Enrolment: 3 participants (actual)
Lead sponsor: Eric B. SuhlerUniversity, hospital or other
Collaborators: Genentech, Inc.
Study start: Nov 2013
Primary completion: Feb 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 22 May 2012 (estimated)
Results: Posted 27 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Tocilizumab	Experimental	Drug: Tocilizumab

Who may qualify

Ages: 2 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (41 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TocilizumabAlso: ActemraIntravenous 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	Drug	Tocilizumab

Primary outcome

Number of Participants With Control of Ocular Inflammation
Time frame: 16 Weeks
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

Results and safety

Results posted to the registry on 27 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tocilizumab	3	1

Primary outcome: Number of Participants With Control of Ocular Inflammation

Time frame: 16 Weeks. Count of participants. Unit: Participants

Measure	Tocilizumab n = 3
Value	1

Adverse events

Time frame: 18 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tocilizumab	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Juvenile Idiopathic Arthritis Associated Uveitis

Not yet recruitingObservational study
Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research
Pericarditis, Tako-TSUBO Cardiomyopathy
Not yet recruitingPhase 4
Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial
Juvenile Idiopathic Arthritis Associated Uveitis, Uveitis, Anterior
RecruitingObservational study
EACVI Study on Multimodality Cardiovascular Imaging of Inflammatory Cardiovascular Diseases
Myocarditis, ANCA Associated Vasculitis
Active, not recruitingPhase 3
A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis
Uveitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eric B Suhler, MD,MPH principal investigator

Oregon Health and Science University

James T Rosenbaum, MD study director

Oregon Health and Science University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Tocilizumab in people with Juvenile Idiopathic Arthritis Associated Uveitis, run by Eric B. Suhler at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Control of Ocular Inflammation (time frame: 16 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01603355.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019.