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Intermediate UveitisPhase 1/2STOP-UveitisNCT01717170

Study of the Safety, Tolerability, and Bioactivity of Tocilizumab On Patients With Non-infectious UVEITIS: The STOP-UVEITIS Study

A Phase 1/2 study testing Tocilizumab in people with Intermediate Uveitis and Posterior Uveitis, run by University of Nebraska at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In the STOP-UVEITIS study, we propose to evaluate the safety, tolerability, and bioactivity of two doses of Tocilizumab (4mg/kg and 8mg/kg), administered monthly, in patients with non-infectious intermediate, posterior, or panuveitis. Read more about this study

Who is it for?
Ages 18 to 100 years
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
36 participants
Where
1 siteUnited States
Study dates
Mar 2013to Dec 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

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 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18;
  • Able to give informed consent and attend all study visits;
  • Have diagnosis of uveitis determined by the Investigator to be non-infectious;
  • Have active uveitis, defined as having at least 1+ Vitreous Haze (SUN scale) in study eye. As mentioned above, at least 12 of the randomized subjects must also have vitreous haze of ≥ 2+ vitreous haze. and:
  • are receiving no other treatment; or,
  • are receiving prednisone ≥10 mg/day (or equivalent dose of another corticosteroid) and/or at least 1 other systemic immunosuppressant;
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  • Have posterior, intermediate, or panuveitis; for panuveitis, if an anterior component is present, it must be less than the posterior component;
  • Sufficient inflammation to require systemic treatment or long-term regional treatment. Patients whom the investigators feel may only need short-term topical therapy should not be enrolled.
  • Best-corrected EARLY TREATMENT DIABETIC RETINOPATHY STUDY(ETDRS) visual acuity of 20/20 to 20/400 (approximately 80 to 20 letters) in the study eye;
  • Best- corrected ETDRS visual acuity of 20/400 or better in the fellow eye (approximately 20 letters).
  • Must have a chest radiograph within 3 months prior to enrollment with no evidence of malignancy, infection or fibrosis.
  • Females of childbearing potential must have a negative serum pregnancy test at screening. In addition, sexually active females of childbearing potential must agree to use TWO of the following adequate forms of contraception while on study medication: oral, injectable, or implantable hormonal contraceptives; tubal ligation; intrauterine device; barrier contraceptive with spermicide; or vasectomized partner.
  • Males must agree to use barrier contraception (latex condoms) when engaging in sexual activity while on study medication and for 28 days after taking the last dose of study medication.
  • Subjects with a documented history of non-infectious intermediate-, anterior and intermediate, posterior, or pan-uveitis including but not restricted to: intermediate uveitis, sarcoidosis, Vogt-Koyanagi-Harada (VKH) syndrome, birdshot retinochoroidopathy, retinal vasculitis, sympathetic ophthalmia, multifocal choroiditis with panuveitis. Prior to study screening, potential subjects must have been evaluated and screened for infectious etiologies by the investigators, possibly as part of standard clinical acre; all testing to rule out infectious causes must be performed within 3 months of screening for the STOP-UVEITIS study.
  • Currently active and uncontrolled uveitis (of the types mentioned above) that at the determination of the investigator, requires the initiation of corticosteroid monotherapy at a dose of ≥ 10 mg/day (or equivalent) or prednisone therapy and immunomodulatory therapy or injections of corticosteroid (intravitreal or periocular); or uveitis in subjects for whom oral corticosteroid is contraindicated, relatively or absolutely.
  • Evidence of active non-infectious ocular inflammation, that at the determination of investigator, requires therapy (e.g. vitreous cells, vitreous haze, retinal vasculitis, chorioretinitis). Such evidence can be documented by clinical examination, photography, or ancillary testing (e.g. fluorescein angiography, indocyanine green (ICG), optical coherence tomography). As long as the investigator determines that the degree of inflammation can be monitored for regression or progression, the inflammation criterion can be met.
  • Not planning to undergo elective ocular surgery during the first 6 months of the study.

Who cannot join

  • Any significant ocular disease that could compromise vision in the study eye. These include, but are not limited to:
  • Diabetic retinopathy: proliferative diabetic retinopathy (PDR) or non-proliferative diabetic retinopathy (NPDR) that compromise the vision.
  • Age-related macular degeneration;
  • Myopic degeneration with active subfoveal choroidal neovascularization.
  • Advanced glaucoma status post trabeculectomy or tube/valve placement
  • Any of the following treatments within 90 days prior to Day 0 or anticipated use of any of the following treatments to the study eye:
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  • Intravitreal injections (including but not limited to steroids or anti-vascular endothelial growth factors);
  • Posterior subtenon's steroids
  • Intraocular surgery within 90 days prior to Day 0 in the study eye;
  • Capsulotomy within 30 days prior to Day 0 in the study eye;
  • History of vitreoretinal surgery or scleral buckling
  • Any ocular surgery (including cataract extraction or capsulotomy) of the study eye anticipated within the first 180 days following Day 0;
  • Intraocular pressure (IOP) ≥25 mmHg in the study eye (glaucoma patients maintained on no more than 2 topical medications with IOP <25 mmHg are allowed to participate);
  • Pupillary dilation inadequate for quality stereoscopic fundus photography in the study eye;
  • Media opacity that would limit clinical visualization;
  • Presence of any form of ocular malignancy in the study eye, including choroidal melanoma;
  • History of herpetic infection in the study eye or adnexa;
  • Presence of known active or inactive toxoplasmosis in either eye;
  • Ocular or periocular infection in either eye;
  • Participation in other investigational drug or device clinical trials within 30 days prior to Day 0, or planning to participate in other investigational drug or device clinical trials within 180 days following Day 0. This includes both ocular and non-ocular clinical trials
  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
  • Prior treatment with any cell-depleting therapies, including investigational agents or approved therapies, some examples are CAMPATH, anti-CD4, anti-CD5, anti¬CD3, anti-CD19 and anti-CD20
  • Treatment with intravenous gamma globulin, plasmapheresis or Prosorba column within 6 months of baseline
  • Immunization with a live/attenuated vaccine within 4 weeks prior to baseline
  • Previous treatment with tocilizumab (TCZ)
  • Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation
  • History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
  • Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (include uncontrolled diabetes mellitus) or gastrointestinal disease (including complicated diverticulitis, ulcerative colitis, or Crohn"s disease)
  • Current liver disease as determined by principal investigator unless related to primary disease under investigation
  • Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, Hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds)
  • 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
  • Active tuberculosis (TB) requiring treatment within the previous 3 years. Patients should be screened for latent TB and, if positive, treated following local practice guidelines prior to initiating (Tocilizumab)TCZ. Patients treated for tuberculosis with no recurrence in 3 years are permitted
  • Primary or secondary immunodeficiency (history of or currently active)
  • Evidence of active malignant disease, malignancies diagnosed within the previous 5 years (including hematological malignancies and solid tumors, except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured)
  • Pregnant women or nursing (breast feeding) mothers
  • Patients with reproductive potential not willing to use an effective method of contraception
  • History of alcohol, drug or chemical abuse within 1 year prior to screening.
  • Neuropathies or other conditions that might interfere with pain evaluation unless related to primary disease under investigation
  • Patients with lack of peripheral venous access
  • Serum creatinine > 1.6 mg/dL (141 μmol/L) in female patients and > 1.9 mg/dL(168 μmol/L) in male patients. Patients with serum creatinine values exceeding limits may be eligible for the study if their estimated glomerular filtration rates (GFR) are >30.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times upper limit of normal (ULN)
  • Total Bilirubin > ULN
  • Platelet count < 100 x 109/L (100,000/mm3)
  • Hemoglobin < 85 g/L (8.5 g/dL; 5.3 mmol/L)
  • White Blood Cells < 3.0 x 109/L (3000/mm3)
  • Absolute Neutrophil Count < 2.0 x 109/L (2000/mm3)
  • Absolute Lymphocyte Count < 0.5 x 109/L (500/mm3)
  • Positive Hepatitis BsAg, or Hepatitis C antibody

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Truhlsen Eye Institute, University Of Nebraska Medical Center

    Omaha, Nebraska, 68105

Other trials in United States

About this study

In the STOP-UVEITIS study, we propose to evaluate the safety, tolerability, and bioactivity of two doses of Tocilizumab (4mg/kg and 8mg/kg), administered monthly, in patients with non-infectious intermediate, posterior, or panuveitis.

Being tested
Tocilizumab
Keywords
Non-infectious Uveitis, Tocilizumab
Medical subject headings
Uveitis, Intermediate, Uveitis, Posterior

What participants receive

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

  • TocilizumabDrug

    Also called ACTEMRA

    Tocilizumab (4 mg/kg or 8 mg/kg)

Study groups in NCT01717170
Study groupRoleWhat they receive
Tocilizumab (4 mg/kg)ExperimentalTocilizumab (4 mg/kg) as an intravenous infusion over 1 hour at day 0, 30, 60, 90, 120, and 150.
Receives: Drug: Tocilizumab
Tocilizumab (8 mg/kg)ExperimentalTocilizumab (8 mg/kg) as an intravenous infusion over 1 hour at day 0, 30, 60, 90, 120, and 150.
Receives: Drug: Tocilizumab

What is being measured

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

  1. Frequency and severity of adverse events from baseline (BL) to month 6.

    Safety and tolerability of repeated Tocilizumab infusions in patients with non-infectious uveitis, as assessed by frequency and severity of adverse events from baseline (BL) to month 6.

    Measured: Baseline (BL) to month 6.

Secondary outcomes (1)

  1. Frequency and severity of adverse events at month 12.

    Safety and tolerability of repeated Tocilizumab infusions in patients with non-infectious uveitis, as assessed by frequency and severity of adverse events at month 12.

    Measured: Baseline to Month 12

Timeline

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

  1. First posted30 Oct 2012 (estimated)
  2. Study startMar 2013
  3. Primary completionJun 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01717170
Sponsor's protocol ID
ML28522
Acronym
STOP-Uveitis
Status last verified
Apr 2017
First submitted
26 Oct 2012
Last updated
28 Apr 2017
Results posted
No
Data monitoring committee
No

Publications

  • Sadiq MA, Hassan M, Afridi R, Halim MS, Do DV, Sepah YJ, Nguyen QD; STOP-UVEITIS Investigators. Posterior segment inflammatory outcomes assessed using fluorescein angiography in the STOP-UVEITIS study. Int J Retina Vitreous. 2020 Oct 6;6:47. doi: 10.1186/s40942-020-00245-w. eCollection 2020.

    PubMed 33042579

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Tocilizumab in people with Intermediate Uveitis and Posterior Uveitis, run by University of Nebraska 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 17 inclusion and 48 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: status not confirmed, as of the sponsor's last update on 28 Apr 2017. 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?

Results are not available in the source record.

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?

Frequency and severity of adverse events from baseline (BL) to month 6. (time frame: Baseline (BL) to month 6.). 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 NCT01717170, which also lists 1 linked publication.

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 28 Apr 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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