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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Status: Withdrawn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

Page last updated: August 23, 2015

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