Infliximab to Improve Retention of the Boston Keratoprosthesis in Patients After Stevens Johnson Syndrome/ Toxic Epidermal Necrolysis (SJS/TENS)

NCT01256489 | Withdrawn Phase 1 DMC

• 2 other identifiers: 10-02-010196405
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study is intended to test the idea, based upon current knowledge of the biology and physiology of corneal ulceration in SJS/TENS patients who receive a keratoprosthesis, and on the known effects of infliximab on matrix metalloproteinases, that infliximab therapy for such patients may reduce the likelihood of corneal ulceration, and hence extend the period of prosthesis retention and vision recovery.

Conditions

Stevens-Johnson Syndrome; Corneal Blindness

Keywords

KPro; Keratoprosthesis; Stevens-Johnson Syndrome; Infliximab; Corneal Blindness

Outcome Measures

Primary Outcomes (1)

• Occurrence of corneal ulceration

  Assessed monthly for up to 2 years following surgery

Secondary Outcomes (3)

• Occurrence of systemic adverse events

  Assessed monthly for up to 2 years following first infusion

• Period Of Prosthesis Retention

  Assessed monthly for up to 2 years following surgery

• Vision Recovery

  Assessed monthly for up to 2 years following surgery

Study Arms (1)

Infliximab

OTHER

Every patient enrolled in the study will receive monthly infusions of Infliximab throughout the term of the study. Infliximab will be administered intravenously.

Drug: Infliximab

Interventions

Infliximab DRUG

The drug will be administered intravenously every month for 110 weeks (duration of the study). The initial dose of infliximab will be 5mg/kg of body weight. The dose may be adjusted up to a maximal dosing of 10mg/kg depending upon disease activity, as judged by the investigators.

Also known as: Remicade

Infliximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of biopsy proven SJS/TENS with corneal opacity and neovascularization
• Bilateral legal blindness (\<20/200 in better eye)
• years of age or older
• Able to provide informed consent
• Sufficiently healthy to undergo infliximab infusions, surgery, and a vigorous postoperative follow-up course
• Able to administer eye medications or have a care giver able and willing to do same
• Are considered eligible according to the following tuberculosis (TB) screening criteria:
• Have no history of latent or active TB prior to screening.
• Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
• Have had no recent close contact with a person with active TB.
• Within 6 weeks prior to the first administration of study agent, have a negative QuantiFERON-TB Gold test result (see Attachment A). Indeterminate results should be handled as outlined in the Screening Visit Section. A negative tuberculin skin test is considered acceptable if the QuantiFERON- TB Gold test is not acceptable in that country.
• Have a chest radiograph (posterior-anterior view) taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current, active TB or old, inactive TB.

You may not qualify if:

• Visual acuity \>20/200 in better eye
• Corneal blindness not due to effects of SJS/TENS
• Hypersensitivity to infliximab or chemically related medication
• Pregnant or lactating
• Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.
• Have a chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including TB.
• Have had a nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, pneumocystosis, aspergillosis) within 6 months prior to screening.
• Have indeterminate initial and repeat QuantiFERON-TB Gold test results.
• History or current diagnosis of diabetes mellitus
• History of immune system problem other than Stevens Johnson Syndrome
• History of recurrent infections
• History or current diagnosis of cancer
• Active psoriasis
• History of heart failure
• History of hepatitis B virus

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Stevens-Johnson Syndrome

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Erythema Multiforme; Erythema; Skin Diseases, Vesiculobullous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• James Chodosh, MD, MPH

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2010
• First Posted: December 8, 2010
• Study Start: December 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: November 4, 2015

Record last verified: 2015-01

Locations

US (1)