Pilot Study of the Evaluation of Infliximab in the Treatment of Non-Infectious Scleritis


Phase 1
18 Years
N/A
Not Enrolling
Both
Scleritis

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Trial Information

Pilot Study of the Evaluation of Infliximab in the Treatment of Non-Infectious Scleritis


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.

Inclusion Criteria


- INCLUSION CRITERIA:

To be eligible to enroll in this study, a prospective participant must satisfy the
following inclusion criteria:

1. Participant is 18 years of age or older.

2. 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.

3. Participant has normal renal or liver function.

4. Participant agrees to use acceptable birth control methods throughout the course of
the study and for 6 months after completion of treatment.

5. Participant has no evidence of tuberculosis as documented by tuberculin skin test
performed prior to enrollment (chest x-ray, if medically indicated).

6. Participant is able to understand and sign a consent form before entering the study.

7. Participant has been treated with prednisone or other immunomodulatory medications
but present with active disease at the time of enrollment.

EXCLUSION CRITERIA:

To be eligible to enroll in this study, a prospective participant must not satisfy any of
the following exclusion criteria:

1. 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.

2. Participant with a corneal melting, necrotizing keratitis, or impending vision loss.

3. Participant with scleritis of infectious etiology.

4. 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.

5. Participant has significant active infection requiring hospitalization.

6. Participant with multiple sclerosis.

7. Participant has severe (class 3/4) congestive heart failure.

8. Participant has a history of cancer within the past 5 years other than basal or
squamous cell carcinoma.

9. Participant is pregnant or lactating as it is unknown whether infliximab is excreted
in human milk or absorbed systemically after ingestion.

10. Evidence of liver disease (any etiology).

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

040065

NCT ID:

NCT00075075

Start Date:

December 2003

Completion Date:

September 2007

Related Keywords:

  • Scleritis
  • Infliximab
  • Scleritis
  • Intraocular Inflammatory Disease
  • Corticosteroids
  • Immunosuppressives
  • Scleritis

Name

Location
National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892