Chronic UveitisPhase 4NCT00589628
Multi Center Prospective Registry of Infliximab Use for Childhood Uveitis
A Phase 4 study testing infliximab in people with Chronic Uveitis, run by Egla C. Rabinovich at 1 site in United States.
Trial summary
The primary objective of this study is to examine the efficacy of infliximab for the treatment of persistent uveitis in children. Participants (4-18 years of age) will be randomly assigned to either 5mg/kg or 10mg/kg dose of infliximab to be administered by intravenous infusion at four week intervals. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Chronic Uveitis
- What is being tested?
- infliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Dec 2010
- Phase
- Phase 4
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 4 to 18 years old,
- Non-infectious uveitis
- Persistent uveitis uncontrolled by topical medications, or unacceptable side effects of topical medications.
- Failure of at least six weeks of treatment with a non-biological disease modifying agent such as methotrexate, cyclosporine, mycophenolate mofetil, or azathioprine.
- Ability to provide informed consent (subject or parent/guardian)
- Onset of uveitis < 16 years of age.
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- Topical ophthalmologic treatments allowed.
- Systemic corticosteroid use at entry may be allowed.
- Willingness to use acceptable contraception if sexually active for the duration of the study and for 6 months after receiving the last infliximab infusion.
- Concomitant methotrexate must be taken at time of initiation of infliximab
- Participant must be able to cooperate for a non-sedated slit lamp exam and visual acuity examination.
- Negative Purified Protein Derivative (PPD) placed and read within 1 month of initiation of infliximab
- The screening laboratory test results must meet the following criteria:
- WBC (white blood cell count): within normal range for institution
- ANC (absolute neutrophil count): within normal range for institution
- Hemoglobin: greater than 10 grams/deciliter
- Platelets: within normal range for institution
- Serum Creatinine: within normal range for age
- AST - aspartate aminotransferase - within normal range for institution
- ALT - alanine aminotransferase- within normal range for institution
Who cannot join
- Previous use of biologic medications for uveitis.
- Intraocular steroid injection or ophthalmologic surgery within the preceding 3 months.
- Uveitis due to trauma or intraocular surgery
- Females who are pregnant, nursing, or planning pregnancy within 6 months after the last infliximab infusion.
- Males who plan on fathering a child within 6 months after their last infliximab infusion.
- A history of a known allergy to murine products.
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- Documentation of seropositivity for human immunodeficiency virus (HIV).
- Documentation of a positive test for hepatitis B surface antigen or hepatitis C
- A known history of a serious infection (e.g., hepatitis, pneumonia, or pyelonephritis) in the previous 3 months.
- An opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
- A concomitant diagnosis or history of congestive heart failure.
- A history of lymphoproliferative disease.
- Any known malignancy or a history of malignancy.
- Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
- Use of any investigational drug within 30 days prior to screening or within five half-lives of the first dose of the investigational agent, whichever is longer.
- Presence of a transplanted solid organ.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
The primary objective of this study is to examine the efficacy of infliximab for the treatment of persistent uveitis in children. Participants (4-18 years of age) will be randomly assigned to either 5mg/kg or 10mg/kg dose of infliximab to be administered by intravenous infusion at four week intervals. Participant responses will be measured at at four to eight week intervals for up to ten months.
Read the detailed description
Pediatric rheumatologists often use infliximab in the treatment of childhood uveitis, at this time there are no prospective studies for this use. Participants will be randomized to initial suggested dose of infliximab (5 mg/kg/dose vs 10 mg/kg/dose) and data will be collected prospectively with regard to ophthalmologic outcomes. Study participants will be followed for up to 10 months to determine efficacy and side effects, and an additional 30 days for safety reports. Descriptive statistics will be gathered on participant demographics, uveitis characteristics, change in immunosuppressive medications, number of responders, ophthalmologic measures and change in corticosteroid dose during the study period. Initial to final dose will be examined by paired t-test. The proportion of responders in the 5 mg/kg initial dose group will be compared to the 10 mg/kg/dose by a Chi-square or Fisher's exact test, depending on numbers available. Predictors of response will be examined by logistic regression.
- Conditions
- Chronic Uveitis
- Being tested
- infliximab
- Keywords
- Childhood, Uveitis
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infliximabDrug
Also called Remicade
5mg/kg/dose IV at 4 week intervals
infliximabDrug
Also called Remicade
10mg/kg/dose IV at 4 week intervals
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 5mg/kg/dose of infliximab IV every 4 weeks for 9 doses Receives: Drug: infliximab |
| 2 | Active comparator | 10mg/kg/dose of infliximab IV every 4 weeks for 9 doses. Receives: Drug: infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Infliximab on Uveitis Disease Activity.
Number of subjects with improvement in uveitis, defined as a two step decrease in level of inflammation (as defined by SUN criteria, AC cells, vitreous haze) or decrease to grade 0. A grading scheme of 0 indicating (<1 cell/ocular field) low levels of inflammation to 4+ indicating (>50 cells/ocular field) indicating high levels of inflammation.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startSep 2007
- Primary completionDec 2010
- Study completionDec 2010
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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egla C. Rabinovich
- Sponsor type
- University, hospital or other
- Collaborators
- Childhood Arthritis and Rheumatology Research Alliance
- Responsible party
- Sponsor-investigator, Egla C. Rabinovich, Duke University
- Investigators
- Egla Rabinovich, MD. MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00589628
- Sponsor's protocol ID
- Pro00000057
- Status last verified
- Aug 2013
- First submitted
- 27 Dec 2007
- Last updated
- 26 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Heiligenhaus A, Foeldvari I, Edelsten C, Smith JR, Saurenmann RK, Bodaghi B, de Boer J, Graham E, Anton J, Kotaniemi K, Mackensen F, Minden K, Nielsen S, Rabinovich EC, Ramanan AV, Strand V; Multinational Interdisciplinary Working Group for Uveitis in Childhood. Proposed outcome measures for prospective clinical trials in juvenile idiopathic arthritis-associated uveitis: a consensus effort from the multinational interdisciplinary working group for uveitis in childhood. Arthritis Care Res (Hoboken). 2012 Sep;64(9):1365-72. doi: 10.1002/acr.21674.
PubMed 22438273Ardoin SP, Kredich D, Rabinovich E, Schanberg LE, Jaffe GJ. Infliximab to treat chronic noninfectious uveitis in children: retrospective case series with long-term follow-up. Am J Ophthalmol. 2007 Dec;144(6):844-849. doi: 10.1016/j.ajo.2007.08.018. Epub 2007 Oct 22.
PubMed 17953940Saurenmann RK, Levin AV, Rose JB, Parker S, Rabinovitch T, Tyrrell PN, Feldman BM, Laxer RM, Schneider R, Silverman ED. Tumour necrosis factor alpha inhibitors in the treatment of childhood uveitis. Rheumatology (Oxford). 2006 Aug;45(8):982-9. doi: 10.1093/rheumatology/kel030. Epub 2006 Feb 3.
PubMed 16461435Kahn P, Weiss M, Imundo LF, Levy DM. Favorable response to high-dose infliximab for refractory childhood uveitis. Ophthalmology. 2006 May;113(5):860-4.e2. doi: 10.1016/j.ophtha.2006.01.005. Epub 2006 Mar 20.
PubMed 16545455Rajaraman RT, Kimura Y, Li S, Haines K, Chu DS. Retrospective case review of pediatric patients with uveitis treated with infliximab. Ophthalmology. 2006 Feb;113(2):308-14. doi: 10.1016/j.ophtha.2005.09.037. Epub 2006 Jan 10.
PubMed 16406545
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Center Prospective Registry of Infliximab Use for Childhood Uveitis
- ClinicalTrials.gov ID
- NCT00589628
- Acronym / sponsor ID
- Pro00000057
- Conditions
- Chronic Uveitis
- Keywords
- Childhood, Uveitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Egla C. RabinovichUniversity, hospital or other
- Collaborators
- Childhood Arthritis and Rheumatology Research Alliance
- Study start
- Sep 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Jan 2008 (estimated)
- Results
- Posted 26 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to examine the efficacy of infliximab for the treatment of persistent uveitis in children. Participants (4-18 years of age) will be randomly assigned to either 5mg/kg or 10mg/kg dose of infliximab to be administered by intravenous infusion at four week intervals. Participant responses will be measured at at four to eight week intervals for up to ten months.
Detailed description
Pediatric rheumatologists often use infliximab in the treatment of childhood uveitis, at this time there are no prospective studies for this use. Participants will be randomized to initial suggested dose of infliximab (5 mg/kg/dose vs 10 mg/kg/dose) and data will be collected prospectively with regard to ophthalmologic outcomes. Study participants will be followed for up to 10 months to determine efficacy and side effects, and an additional 30 days for safety reports. Descriptive statistics will be gathered on participant demographics, uveitis characteristics, change in immunosuppressive medications, number of responders, ophthalmologic measures and change in corticosteroid dose during the study period. Initial to final dose will be examined by paired t-test. The proportion of responders in the 5 mg/kg initial dose group will be compared to the 10 mg/kg/dose by a Chi-square or Fisher's exact test, depending on numbers available. Predictors of response will be examined by logistic regression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: infliximab5mg/kg/dose of infliximab IV every 4 weeks for 9 doses |
| 2 | Active comparator | Drug: infliximab10mg/kg/dose of infliximab IV every 4 weeks for 9 doses. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (20 listed)
- Ages 4 to 18 years old,
- Non-infectious uveitis
- Persistent uveitis uncontrolled by topical medications, or unacceptable side effects of topical medications.
- Failure of at least six weeks of treatment with a non-biological disease modifying agent such as methotrexate, cyclosporine, mycophenolate mofetil, or azathioprine.
- Ability to provide informed consent (subject or parent/guardian)
Key exclusion criteria (16 listed)
- Previous use of biologic medications for uveitis.
- Intraocular steroid injection or ophthalmologic surgery within the preceding 3 months.
- Uveitis due to trauma or intraocular surgery
- Females who are pregnant, nursing, or planning pregnancy within 6 months after the last infliximab infusion.
- Males who plan on fathering a child within 6 months after their last infliximab infusion.
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 |
|---|---|---|
| infliximabAlso: Remicade5mg/kg/dose IV at 4 week intervals | Drug | 1 |
| infliximabAlso: Remicade10mg/kg/dose IV at 4 week intervals | Drug | 2 |
Primary outcome
Effects of Infliximab on Uveitis Disease Activity.
Time frame: 9 months
Number of subjects with improvement in uveitis, defined as a two step decrease in level of inflammation (as defined by SUN criteria, AC cells, vitreous haze) or decrease to grade 0. A grading scheme of 0 indicating (<1 cell/ocular field) low levels of inflammation to 4+ indicating (>50 cells/ocular field) indicating high levels of inflammation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22438273Heiligenhaus A, Foeldvari I, Edelsten C, Smith JR, Saurenmann RK, Bodaghi B, de Boer J, Graham E, Anton J, Kotaniemi K, Mackensen F, Minden K, Nielsen S, Rabinovich EC, Ramanan AV, Strand V; Multinational Interdisciplinary Working Group for Uveitis in Childhood. Proposed outcome measures for prospective clinical trials in juvenile idiopathic arthritis-associated uveitis: a consensus effort from the multinational interdisciplinary working group for uveitis in childhood. Arthritis Care Res (Hoboken). 2012 Sep;64(9):1365-72. doi: 10.1002/acr.21674.
- Background: PubMed 17953940Ardoin SP, Kredich D, Rabinovich E, Schanberg LE, Jaffe GJ. Infliximab to treat chronic noninfectious uveitis in children: retrospective case series with long-term follow-up. Am J Ophthalmol. 2007 Dec;144(6):844-849. doi: 10.1016/j.ajo.2007.08.018. Epub 2007 Oct 22.
- Results publication: PubMed 16461435Saurenmann RK, Levin AV, Rose JB, Parker S, Rabinovitch T, Tyrrell PN, Feldman BM, Laxer RM, Schneider R, Silverman ED. Tumour necrosis factor alpha inhibitors in the treatment of childhood uveitis. Rheumatology (Oxford). 2006 Aug;45(8):982-9. doi: 10.1093/rheumatology/kel030. Epub 2006 Feb 3.
- Results publication: PubMed 16545455Kahn P, Weiss M, Imundo LF, Levy DM. Favorable response to high-dose infliximab for refractory childhood uveitis. Ophthalmology. 2006 May;113(5):860-4.e2. doi: 10.1016/j.ophtha.2006.01.005. Epub 2006 Mar 20.
- Results publication: PubMed 16406545Rajaraman RT, Kimura Y, Li S, Haines K, Chu DS. Retrospective case review of pediatric patients with uveitis treated with infliximab. Ophthalmology. 2006 Feb;113(2):308-14. doi: 10.1016/j.ophtha.2005.09.037. Epub 2006 Jan 10.
- Research Information. Click on current studiesLink provided by the sponsor.
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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.
Egla Rabinovich, MD. MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing infliximab in people with Chronic Uveitis, run by Egla C. Rabinovich 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 20 inclusion and 16 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: finished, as of the sponsor's last update on 26 Aug 2013. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 26 Aug 2013). 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?
Effects of Infliximab on Uveitis Disease Activity. (time frame: 9 months). 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 NCT00589628, which also lists 5 linked publications.
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 26 Aug 2013.