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An Open Label Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab, Remicade®) in the Treatment of Endogenous Uveitis or Vasculitis unresponsive to Standard Therapy.


- candidate number1540
- NTR NumberNTR491
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested18-nov-2005
- Date Registered NTR11-sep-2005
- Secondary IDsN/A 
- Public TitleAn Open Label Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab, Remicade®) in the Treatment of Endogenous Uveitis or Vasculitis unresponsive to Standard Therapy.
- Scientific TitleAn Open Label Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab, Remicade®) in the Treatment of Endogenous Uveitis or Vasculitis unresponsive to Standard Therapy.
- ACRONYMRESCU-Study
- hypothesisMulti-centre open label clinical trial.
- Healt Condition(s) or Problem(s) studiedUveitis, Vasculitis
- Inclusion criteria1. Men or women 18 years of age with non-infectious bilateral sight-threatening uveitis due to one of the inflammatory conditions listed below:
a. Ocular sarcoidosis;
b. Intermediate uveitis;
c. Behcet's syndrome;
d. Idiopathic Retinal Vasculitis where systemic or infectious causes have been eliminated. In particular patients will not have evidence of Wegener¡¯s granulomatosis, SLE, PAN, polymyositis, dermatomyositis or other systemic vasculitic disorder;
e. Birdshot;
2. Patients must be taking a minimum of 0.5 mg/kg bodyweight/day of prednisone, cyclosporine or other immunomodulatory agent (mycophenolate, tacrolimus, sirolimus, interferon therapy (in the case of Behçet¡¯s disease), anti-metabolites, or any combination of these for the treatment of their intraocular inflammatory disease, for at least three months;
3. Disease that is 24 months or less in duration, or a patient with a significant flare in the past 24 months requiring intensification of anti-inflammatory therapy;
4. Visual acuity of 0.1 or better in at least one eye. Complete control of intraocular inflammation is not necessary;
5. Men and women of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) for the duration of the study and should continue such precautions for 6 months after receiving the last infusion;
6. The screening laboratory test results must meet the following criteria:
a. Hemoglobin ³ 8.5 g/dL;
b. WBC ³ 3.5 x 109/L;
c. Neutrophils ³ 1.5 x 109/L;
d. Platelets ³ 100 x 109/L;
e. SGOT (AST) and alkaline phosphatase levels must be within 3 times the upper limit of normal range for the laboratory conducting the test;
7. Must have a chest radiograph within 3 months prior to first infusion with no evidence of malignancy, infection or fibrosis suggestive of a [previous] TB infection;
8. Patient must be able to adhere to the study visit schedule and other protocol requirements;
9. The patient must be capable of giving informed consent and the consent must be obtained prior to any screening procedures.
- Exclusion criteria1. Inability to visualize the fundus due to corneal or lenticular opacities;
2. Patients requiring ocular surgery within the initial 3 months of treatment, or who have had surgery in the prior 3 months;
3. Women who are pregnant, nursing, or planning pregnancy within 1.5 years after screening (i.e., approximately 6 months following last infusion);
4. Use of any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer;
5. Treatment with any other therapeutic agent targeted at reducing TNF (e.g., pentoxifylline, thalidomide, etanercept, etc.) within 3 months of screening;
6. Previous administration of infliximab;
7. History of receiving human/murine recombinant products or known allergy to murine products;
8. Serious infections (such as pneumonia or pyelonephritis) in the previous 3 months. Less serious infections (such as acute upper respiratory tract infection [colds] or simple urinary tract infection) need not be considered exclusions at the discretion of the investigator;
9. Documented HIV infection;
10. Have active TB or have evidence of latent TB;
11. Patients with opportunistic infections;
12. Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease;
13. Concomitant congestive heart failure, including medically controlled asymptomatic patients;
14. Any sign and symptom suggestive for a demyelinating disorder;
15. Evidence on T1/T2 weighed MRI of the cerebrum for a demyelinating disorder in patients with intermediate uveitis, within 2 years prior to first infusion and not before the onset of signs and symptoms of intermediate uveitis;
16. Presence of a transplanted organ (with the exception of a corneal transplant > 3 months prior to screening);
17. Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence);
18. History of lymphoproliferative disease including lymphoma;
19. Known recent substance abuse (drug or alcohol);
20. Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling during the study period.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 24-nov-2001
- planned closingdate31-dec-2007
- Target number of participants49
- InterventionsInfusions with infliximab 5 mg/kg bodyweight monotherapy at weeks 0, 2, 6, 14, 22, 30, 38 and 46.
- Primary outcomeTo determine if infliximab 5 mg/kg bodyweight monotherapy at weeks 0, 2, 6, 14, 22, 30, 38 and 46 can allow patients with endogenous uveitis or vasculitis unresponsive to standard therapy, to taper their concomitant immunosuppressants, while maintaining or improving their visual acuity and not meet any of the exit criteria.
- Secondary outcome1. To Determine the number of weeks patients maintain their visual acuity and not meet any of the exit criteria, after infliximab discontinuation at week 46, in patients who did taper their concomitant immunosuppressants and in patients who did not taper their concomitant immunosuppressants;
2. Determine the percentage of patients who meet the exit criteria during the first 46 weeks and during follow-up, in patients who did taper their concomitant immunosuppressants and in patients who did not taper their concomitant immunosuppressants;
3. Determine the effect of infliximab on quality of life, as assessed by the SF-36;
4. Determine the effect of infliximab on the quality of vision as assessed by the NEI-VFQ-25;
5. Safety of infliximab.
- TimepointsN/A
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIES Edith Dijkman, van
- CONTACT for SCIENTIFIC QUERIESProf. Dr. M.D. Smet, de
- Sponsor/Initiator Academic Medical Center (AMC), Medical Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Centocor BV Leiden
- PublicationsN/A
- Brief summaryPatients will not be assigned randomly. All patients will be treated prospectively and will receive infliximab at weeks 0, 2, 6, 14, 22, 30, 38 and 46.

Concomitant systemic:
Immunosuppressants will be tapered starting at week 6 and be completed at week 12, in patients who maintained or improved their visual acuity at week 6 as compared to week 0. The choice of taper will be left to the treating physician, as long as all concomitant systemic immunosuppressants are withdrawn 6 weeks after starting the taper.
An attempt will be made to taper MTX and steroids completely, however a MTX dose up to a maximum of 7.5 mg/week and steroids up to a maximum equivalent dose of 7.5 mg prednisone/day are allowed.

If a patient’s vision acuity worsened while on Infliximab, but did not reach the exit criteria, concomitant immunosuppressants will not be tapered until the vision is equal or better than the baseline vision at week 0. Taper of concomitant immunosuppressants can be started at the latest at week 22.

The exit criteria are reached when the patient has:
1. A drop in visual acuity by 10 or more letters (two lines) on the ETDRS eye chart at a study visit as compared to the previous visit, or more than 10 letters from the baseline vision;
2. An increase in vitreous haze of at least 2 grades from the previous visit (or more than 2 grades from baseline) based on the chart by Nussenblatt et al (17)
3. Evidence of retinal infarction as manifested by new retinal opacification associated with retinal hemorrhage along a retinal artery or vein. The area should measure at least 2 disc diameter;
4. Restarted systemic immunosuppressive therapy or increased the dose of prednisone above 7.5 mg/day or MTX above 7.5 mg/week, as initiated by any physician (whether the investigator or not).
- Main changes (audit trail)
- RECORD11-sep-2005 - 1-feb-2010


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