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Gevokizumab for Active Scleritis

NCT01835132 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2018-07-06

Study results available
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Summary

Background:

\- Scleritis is the inflammation of the white outer coating of the eye, known as the sclera. In severe cases, it can cause blindness. It is commonly associated with autoimmune disorders such as rheumatoid arthritis. Mild scleritis can be treated with drugs such as ibuprofen. More severe scleritis may need oral steroids or immunosuppressive treatments; however, these treatments can cause side effects in the whole body. Gevokizumab is a newer anti-inflammatory drug that is under investigation to treat other inflammatory diseases. It may not have as severe side effects as some other drugs. However, it has not yet been used to treat scleritis. Researchers want to see if it can be given as a safe and effective treatment for scleritis.

Objectives:

\- To see if gevokizumab is a safe and effective treatment for scleritis.

Eligibility:

\- Individuals at least 18 years of age who have active scleritis.

Design:

* There is an initial phase and a two-part extension phase in this study. The extension phase is optional. The initial phase of the study requires seven visits to the National Eye Institute (NEI).
* Participants will be screened with a physical exam and eye exam, and medical history will be obtained. Blood and urine samples will be collected.
* Eligible participants will receive an injection of 60 mg of gevokizumab at the first study visit and at Weeks 4, 8, and 12. They will be given under the skin by the stomach, or in the upper arm or thigh.
* Participants will have additional visits after the first study visit at Weeks 2, 16, and 28. No injection will be given at these visits. Eye exams will be done, and blood and tear samples will be collected.
* If the scleritis improves by Week 16, participants may choose to continue the study in the extension phase. In the 1st extension, they will have a visit every 4 weeks until Week 36 and then two additional monitoring visits at Weeks 40 and 52 for a total of 13 study visits.
* Participants who are eligible at Week 52 may continue in the "as needed" (PRN) extension phase (2nd extension) and receive gevokizumab injections (60 mg) at Weeks 52, 54, 58 and 62.

Conditions

  • Scleritis

Interventions

DEVICE

Gevokizumab

Subcutaneous injection of 60 mg gevokizumab

Sponsors & Collaborators

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • National Eye Institute (NEI)

    lead NIH

Principal Investigators

  • Hatice N Sen, M.D. · National Eye Institute (NEI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-07-31
Completion
2016-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01835132 on ClinicalTrials.gov