Intraarticular Injection of Infliximab
Information source: HaEmek Medical Center, Israel
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arthritis
Intervention: Intraarticular injection of infliximab (Biological)
Phase: Phase 2/Phase 3
Status: Withdrawn
Sponsored by: HaEmek Medical Center, Israel Official(s) and/or principal investigator(s): Reuven Mader, MD, Principal Investigator, Affiliation: Ha'Emek Medical Center, Afula, Israel
Summary
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.
Clinical Details
Official title: Interventional Study: Administration of Intraarticular Injection of Infliximab in Patients With Inflammatory Arthritis Who Failed Intraarticular Injection of Corticosteroids
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: suppression of inflammation
Secondary outcome: Amount of systemic absorbtion
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Bnai Zion Medical Center, Haifa, Israel
Carmel Medical Center and Lin outpatient service, Haifa, Israel
Additional Information
Related 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. 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.
Starting date: March 2010
Last updated: June 25, 2015
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