A Clinical Trial of Infliximab for Uveitis

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Remicade (infliximab)

About this trial

This is an interventional trial for Uveitis

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The study group will include patients suffering from treatment-resistant vision-threatening uveitis who attend the Uveitis Clinic at Casey Eye Institute. We plan to enroll 32 patients. Exclusion Criteria: Patients with ocular or systemic infection. Patients with the subtype of uveitis termed pars planitis who have MRI scan evidence of demyelination. There is a theoretical risk of adverse outcome of TNF-alpha inhibition on the clinical course of multiple sclerosis. Patients who suffer from pars planitis are at increased risk of developing multiple sclerosis. Children under the age of 9. Patients with known sensitivity to mouse proteins. Remicade is a chimeric protein with human and murine components. Patients with history of cancer (exception- skin cancers which are curatively resected), organ transplantation (exception- cornea), recent drug or alcohol addiction, or inability to keep appointments. Patients with other serious systemic diseases that could interfere with participation in the study. It is specifically noted that pregnant women and nursing mothers will be excluded from this study.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00273390

First Posted

January 5, 2006

Last Updated

July 1, 2011

Sponsor

Oregon Health and Science University

Collaborators

Centocor, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00273390

Brief Title

A Clinical Trial of Infliximab for Uveitis

Official Title

The Use of Remicade (Infliximab) in the Management of Vision-threatening Uveitis That is Refractory to Other Modes of Systemic Immunosuppression

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Completed

Study Start Date

August 2001 (undefined)

Primary Completion Date

December 2006 (Actual)

Study Completion Date

December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Oregon Health and Science University

Collaborators

Centocor, Inc.

4. Oversight

5. Study Description

Brief Summary

This project is designed to test the hypothesis that inhibition of binding between tumor necrosis factor alpha (TNF-alpha) and its receptors using Remicade (infliximab, chimeric mouse/human IgG1K monoclonal antibody directed against human TNF-alpha, Centocor, Malvern,PA) is clinically useful for patients with uveitis that is refractory to other forms of systemic immunosuppressive therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uveitis

7. Study Design

Study Phase

Not Applicable

Enrollment

32 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Remicade (infliximab)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: The study group will include patients suffering from treatment-resistant vision-threatening uveitis who attend the Uveitis Clinic at Casey Eye Institute. We plan to enroll 32 patients. Exclusion Criteria: Patients with ocular or systemic infection. Patients with the subtype of uveitis termed pars planitis who have MRI scan evidence of demyelination. There is a theoretical risk of adverse outcome of TNF-alpha inhibition on the clinical course of multiple sclerosis. Patients who suffer from pars planitis are at increased risk of developing multiple sclerosis. Children under the age of 9. Patients with known sensitivity to mouse proteins. Remicade is a chimeric protein with human and murine components. Patients with history of cancer (exception- skin cancers which are curatively resected), organ transplantation (exception- cornea), recent drug or alcohol addiction, or inability to keep appointments. Patients with other serious systemic diseases that could interfere with participation in the study. It is specifically noted that pregnant women and nursing mothers will be excluded from this study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James T Rosenbaum, MD

Organizational Affiliation

Oregon Health and Science University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Eric B Suhler, MD

Organizational Affiliation

Oregon Health and Science University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Justine Smith, MBBS, Phd

Organizational Affiliation

Oregon Health and Science University

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

16009830

Citation

Suhler EB, Smith JR, Wertheim MS, Lauer AK, Kurz DE, Pickard TD, Rosenbaum JT. A prospective trial of infliximab therapy for refractory uveitis: preliminary safety and efficacy outcomes. Arch Ophthalmol. 2005 Jul;123(7):903-12. doi: 10.1001/archopht.123.7.903.

Results Reference

result

PubMed Identifier

19506209

Citation

Suhler EB, Smith JR, Giles TR, Lauer AK, Wertheim MS, Kurz DE, Kurz PA, Lim L, Mackensen F, Pickard TD, Rosenbaum JT. Infliximab therapy for refractory uveitis: 2-year results of a prospective trial. Arch Ophthalmol. 2009 Jun;127(6):819-22. doi: 10.1001/archophthalmol.2009.141. No abstract available.

Results Reference

derived

Uveitis

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial