ScleritisPhase 1NCT00075075
Infliximab to Treat Non-Infectious Scleritis
A Phase 1 study testing Infliximab in people with Scleritis, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
This small, preliminary study will examine whether multiple infusions of infliximab (Remicade® (Registered Trademark)) can control inflammation in patients with active scleritis. The sclera is the tough white outer coat enclosing the eyeball. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleritis
- What is being tested?
- Infliximab
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2003to 6 Sep 2007
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible to enroll in this study, a prospective participant must satisfy the following inclusion criteria:
- Participant is 18 years of age or older.
- Participant has active non-infectious scleritis, diagnosed by a persistent congestion of deep episcleral vessels following a drop of 10% phenylephrine, without active intraocular inflammation.
- Participant has normal renal or liver function.
- Participant agrees to use acceptable birth control methods throughout the course of the study and for 6 months after completion of treatment.
- Participant has no evidence of tuberculosis as documented by tuberculin skin test performed prior to enrollment (chest x-ray, if medically indicated).
- Participant is able to understand and sign a consent form before entering the study.
- Participant has been treated with prednisone or other immunomodulatory medications but present with active disease at the time of enrollment.
Who cannot join
- To be eligible to enroll in this study, a prospective participant must not satisfy any of the following exclusion criteria:
- Participant with a known underlying systemic disease with evidence of serious or potentially lethal uncontrolled active disease in one or more extraocular organ systems for which a defined effective medical regimen is indicated.
- Participant with a corneal melting, necrotizing keratitis, or impending vision loss.
- Participant with scleritis of infectious etiology.
- Participant receiving any other investigational therapy or another anti-TNF agent that would interfere with the ability to evaluate the safety or efficacy of infliximab.
- Participant has significant active infection requiring hospitalization.
Show all 11Show fewer
- Participant with multiple sclerosis.
- Participant has severe (class 3/4) congestive heart failure.
- Participant has a history of cancer within the past 5 years other than basal or squamous cell carcinoma.
- Participant is pregnant or lactating as it is unknown whether infliximab is excreted in human milk or absorbed systemically after ingestion.
- Evidence of liver disease (any etiology).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Pilot Study of the Evaluation of Infliximab in the Treatment of Non-Infectious Scleritis
This small, preliminary study will examine whether multiple infusions of infliximab (Remicade® (Registered Trademark)) can control inflammation in patients with active scleritis. The sclera is the tough white outer coat enclosing the eyeball. Infliximab is a combination of part human and part mouse proteins that block a natural body protein called tumor necrosis factor (TNF). TNF appears to be involved in scleritis, and stopping its action may help reduce the inflammation in the disease. The drug has been approved by the Food and Drug Administration for treating Crohn's disease and rheumatoid arthritis.
Patients 18 years of age or older with active non-infectious scleritis may be eligible for this study. Participants will undergo the following tests and procedures:
Read more
- Medical history and physical examination.
- Eye examination, including a vision test and examination of the retina (back part of the eye) and of the sclera and its blood vessels.
- Questionnaire about vision and daily activities.
- Tuberculin skin test.
- Pregnancy test: Women who can have children are tested for pregnancy at study weeks 0, 14, 30, 38, and 46.
- Infliximab treatment: Infliximab is infused over a 2-hour period through a needle in a vein, usually in the arm. The patient's vital signs are checked before the patient begins each infusion starts and again before leaving the clinic. After the first two infusions, if the disease remains quiet, other scleritis medications will be attempted to be reduced to half the original dose over 8 to 12 weeks and possibly to nothing if the patient continues to do well. Patients receive a maximum of 9 infusions over a 30-week period.
- Blood draws: About 4 tablespoons of blood are drawn at each visit to test for the number and types of cells in the blood and to check for signs of inflammation and side effects of the study medicine.
Patients are seen in the NEI clinic for infusions and to check the response to therapy. This includes 13 clinic visits over 46 weeks, as follows: every 2 weeks for the first 2 weeks, every 4 weeks thereafter for a total of 30 weeks for infusions, and then every 4 weeks for 16 additional weeks.
Patients may stop therapy if their scleritis is not controlled 10 weeks into the study period; if they develop a flare of inflammation after initial control of the active scleritis; if their vision loss is too large; or if their medications increase or other medicines are added to control the scleritis. Patients whose vision decreases minimally, stays the same, or improves may remain in the study.
Read the detailed description
We propose to investigate the possible efficacy of multiple infliximab infusions to control the inflammation in participants presenting with active scleritis. This will be performed using an open-label pilot study. Subjects will receive 5mg/kg intravenous infusions of infliximab at 0, 2, 6 and 10 weeks. After these initial infusions, participants may contine to receive 5 mg/kg dose infusions or may receive 8 mg/kg dose infusions depending on the treamtent response. Treatment response is defined as a decrease in inflammation by at least 2 steps on the scale of grades 0-4 , or a decrease to 0 assessed at week 14. A combination of thse two dose infusions (5 mg/kg or 8 mg/kg) will be given for the remainder of the study according to set schedules. The primary outcome will be the ability to control active scleritis defined as at least a 2-step decrease in sleral inflammation,scleritis within 14 weeks of initiating infliximab therapy. Secondary outcomes will be the amount of reduction in concomitant immunosuppressive medication (measured using the grading scale in Section 4.5.2), changes in pain, redness (measured using a visual analogue scale), photophobia, changes in visual acuity (changes of 10 letters from baseline in best-corrected visual acuity will be considered clinically significant), the typical time between flares, and numbers of flares and times between flares while in the study.
- Conditions
- Scleritis
- Being tested
- Infliximab
- Keywords
- Infliximab, Scleritis, Intraocular Inflammatory Disease, Corticosteroids, Immunosuppressives
- Medical subject headings
- Scleritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2004 (estimated)
- Study start23 Dec 2003
- Study completion6 Sep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ScleritisStudies 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
- Primary purpose
- Treatment
- Enrolment
- 5 participants
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00075075
- Sponsor's protocol ID
- 040065
- Other IDs
- 04-EI-0065
- Status last verified
- 6 Sep 2007
- First submitted
- 31 Dec 2003
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Nguyen QD, Foster CS. Scleral patch graft in the management of necrotizing scleritis. Int Ophthalmol Clin. 1999 Winter;39(1):109-31. doi: 10.1097/00004397-199903910-00011.
PubMed 10083910
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Evaluation of Infliximab in the Treatment of Non-Infectious Scleritis
- ClinicalTrials.gov ID
- NCT00075075
- Acronym / sponsor ID
- 040065
- Conditions
- Scleritis
- Keywords
- Infliximab, Scleritis, Intraocular Inflammatory Disease, Corticosteroids, Immunosuppressives
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 23 Dec 2003
- Study completion
- 6 Sep 2007
- First posted
- 1 Jan 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This small, preliminary study will examine whether multiple infusions of infliximab (Remicade® (Registered Trademark)) can control inflammation in patients with active scleritis. The sclera is the tough white outer coat enclosing the eyeball. Infliximab is a combination of part human and part mouse proteins that block a natural body protein called tumor necrosis factor (TNF). TNF appears to be involved in scleritis, and stopping its action may help reduce the inflammation in the disease. The drug has been approved by the Food and Drug Administration for treating Crohn's disease and rheumatoid arthritis.
Patients 18 years of age or older with active non-infectious scleritis may be eligible for this study. Participants will undergo the following tests and procedures:
- Medical history and physical examination.
- Eye examination, including a vision test and examination of the retina (back part of the eye) and of the sclera and its blood vessels.
- Questionnaire about vision and daily activities.
- Tuberculin skin test.
- Pregnancy test: Women who can have children are tested for pregnancy at study weeks 0, 14, 30, 38, and 46.
- Infliximab treatment: Infliximab is infused over a 2-hour period through a needle in a vein, usually in the arm. The patient's vital signs are checked before the patient begins each infusion starts and again before leaving the clinic. After the first two infusions, if the disease remains quiet, other scleritis medications will be attempted to be reduced to half the original dose over 8 to 12 weeks and possibly to nothing if the patient continues to do well. Patients receive a maximum of 9 infusions over a 30-week period.
- Blood draws: About 4 tablespoons of blood are drawn at each visit to test for the number and types of cells in the blood and to check for signs of inflammation and side effects of the study medicine.
Patients are seen in the NEI clinic for infusions and to check the response to therapy. This includes 13 clinic visits over 46 weeks, as follows: every 2 weeks for the first 2 weeks, every 4 weeks thereafter for a total of 30 weeks for infusions, and then every 4 weeks for 16 additional weeks.
Patients may stop therapy if their scleritis is not controlled 10 weeks into the study period; if they develop a flare of inflammation after initial control of the active scleritis; if their vision loss is too large; or if their medications increase or other medicines are added to control the scleritis. Patients whose vision decreases minimally, stays the same, or improves may remain in the study.
Detailed description
We propose to investigate the possible efficacy of multiple infliximab infusions to control the inflammation in participants presenting with active scleritis. This will be performed using an open-label pilot study. Subjects will receive 5mg/kg intravenous infusions of infliximab at 0, 2, 6 and 10 weeks. After these initial infusions, participants may contine to receive 5 mg/kg dose infusions or may receive 8 mg/kg dose infusions depending on the treamtent response. Treatment response is defined as a decrease in inflammation by at least 2 steps on the scale of grades 0-4 , or a decrease to 0 assessed at week 14. A combination of thse two dose infusions (5 mg/kg or 8 mg/kg) will be given for the remainder of the study according to set schedules. The primary outcome will be the ability to control active scleritis defined as at least a 2-step decrease in sleral inflammation,scleritis within 14 weeks of initiating infliximab therapy. Secondary outcomes will be the amount of reduction in concomitant immunosuppressive medication (measured using the grading scale in Section 4.5.2), changes in pain, redness (measured using a visual analogue scale), photophobia, changes in visual acuity (changes of 10 letters from baseline in best-corrected visual acuity will be considered clinically significant), the typical time between flares, and numbers of flares and times between flares while in the study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- To be eligible to enroll in this study, a prospective participant must satisfy the following inclusion criteria:
- Participant is 18 years of age or older.
- Participant has active non-infectious scleritis, diagnosed by a persistent congestion of deep episcleral vessels following a drop of 10% phenylephrine, without active intraocular inflammation.
- Participant has normal renal or liver function.
- Participant agrees to use acceptable birth control methods throughout the course of the study and for 6 months after completion of treatment.
Key exclusion criteria (11 listed)
- To be eligible to enroll in this study, a prospective participant must not satisfy any of the following exclusion criteria:
- Participant with a known underlying systemic disease with evidence of serious or potentially lethal uncontrolled active disease in one or more extraocular organ systems for which a defined effective medical regimen is indicated.
- Participant with a corneal melting, necrotizing keratitis, or impending vision loss.
- Participant with scleritis of infectious etiology.
- Participant receiving any other investigational therapy or another anti-TNF agent that would interfere with the ability to evaluate the safety or efficacy of infliximab.
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 |
|---|---|---|
| Infliximab | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 10083910Nguyen QD, Foster CS. Scleral patch graft in the management of necrotizing scleritis. Int Ophthalmol Clin. 1999 Winter;39(1):109-31. doi: 10.1097/00004397-199903910-00011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Infliximab in people with Scleritis, run by National Eye Institute (NEI) 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 11 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 2 Jul 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00075075, 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 2 Jul 2017.