Intraarticular Injection of Infliximab
Interventional Study: Administration of Intraarticular Injection of Infliximab in Patients With Inflammatory Arthritis Who Failed Intraarticular Injection of Corticosteroids
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Haifa, Israel
- Bnai Zion Medical Center
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Haifa, Israel
- Carmel Medical Center and Lin outpatient service
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: E
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A single injection of 100 mg of infliximab
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
suppression of inflammation
Time Frame: 12 weeks
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Amount of systemic absorbtion
Time Frame: 2,4,8,12weeks
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2,4,8,12weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Reuven Mader, MD, Ha'Emek Medical Center, Afula, Israel
Publications and helpful links
General Publications
- Schatteman L, Gyselbrecht L, De Clercq L, Mielants H. Treatment of refractory inflammatory monoarthritis in ankylosing spondylitis by intraarticular injection of infliximab. J Rheumatol. 2006 Jan;33(1):82-5. Epub 2005 Nov 15.
- Conti F, Priori R, Chimenti MS, Coari G, Annovazzi A, Valesini G, Signore A. Successful treatment with intraarticular infliximab for resistant knee monarthritis in a patient with spondylarthropathy: a role for scintigraphy with 99mTc-infliximab. Arthritis Rheum. 2005 Apr;52(4):1224-6. doi: 10.1002/art.20979.
- Nikas SN, Temekonidis TI, Zikou AK, Argyropoulou MI, Efremidis S, Drosos AA. Treatment of resistant rheumatoid arthritis by intra-articular infliximab injections: a pilot study. Ann Rheum Dis. 2004 Jan;63(1):102-3. doi: 10.1136/ard.2003.006981. No abstract available.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0088-07-EMC
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