Intraarticular Injection of Infliximab

Study Overview
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Brief Summary
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Intra-articular (IA) injection of medication is a common procedure in the management of joint disorders. In particular, the procedure is effective in the treatment of inflammatory conditions, with long acting corticosteroids most commonly used. These agents have been shown to reduce the signs and symptoms of inflammation, expressed primarily in the synovium of the joint, and are probably capable of slowing the progression of damage to joint cartilage and bone in some of these inflammatory conditions. Arthritis that is refractory to IA corticosteroid injections may respond to surgical, chemical, or, radioisotope synovectomy, procedures in which the inflamed synovial tissue is eradicated. It has been noted that infliximab, a monoclonal antibody directed to Tumor Necrosis Factor (TNF) - α, has high affinity for the TNF-α rich inflamed synovium. Recently, clinical benefit from IA injections of infliximab has been reported in some cases that were refractory to IA injections of corticosteroids. Similarly, the effectiveness of IA infliximab in suppression of joint inflammation has also been demonstrated in patients who could not receive systemic therapy with infliximab. These reports examined the effect of a single injection of infliximab100 mg injected into a large inflamed joint or 2 IA injections 24 hours apart. We propose to further evaluate the use of IA infliximab in patients with intractable knee monoarthritis, explore the optimal mode of its employment, and assess the degree of infliximab systemic absorption from the IA injection. In a pilot study 40 knees will be evaluated, 20 injected with infliximab and 20 injected with a corticosteroid comparator reflecting the current standard of care.

Official Title
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Interventional Study: Administration of Intraarticular Injection of Infliximab in Patients With Inflammatory Arthritis Who Failed Intraarticular Injection of Corticosteroids

Conditions
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Arthritis

Intervention / Treatment
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* Biological: Intraarticular injection of infliximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have non-infectious monoarthritis of the knee and with inadequate response to IA injection of corticosteroids, at least 3 months before enrollment. or Have oligo or polyarthritis controlled by disease modifying agents (DMARDs) but with residual 1-2 inflamed joints, one of which is a knee with inadequate response to IA injection of corticosteroids within 3 months Have negative PPD skin test. Have no evidence of TB on chest x-ray. Be negative for HBsAg and HCV. No evidence of infectious arthritis Exclusion Criteria: Known allergy to infliximab. Known allergy to lidocaine. Pregnant. Female patients with childbearing potential who do not practice effective methods of contraception. Suffer from a chronic infection. On systemic anti TNF-α or other biologic agents

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E<br> | Biological: Intraarticular injection of infliximab<br>* A single injection of 100 mg of infliximab<br>* Other names: Remicade;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| suppression of inflammation |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of systemic absorbtion |  | 2,4,8,12weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraarticular injection, Infliximab