Intraarticular Injection of Infliximab

Phase 2

Withdrawn

• Conditions: Arthritis
• Interventions: Biological: Intraarticular injection of infliximab

• Registration Number: NCT00521963
• Lead Sponsor: HaEmek Medical Center, Israel

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-17
• Study First Submitted QC: 2007-08-27
• Study First Posted: 2007-08-28
• Study Start: 2010-03
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-25
• Last Update Posted: 2015-06-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E	Intraarticular injection of infliximab	-

Primary Outcome Measures

Name	Time	Method
suppression of inflammation	12 weeks

Secondary Outcome Measures

Name	Time	Method
Amount of systemic absorbtion	2,4,8,12weeks

Trial Locations

Locations (2)

Carmel Medical Center and Lin outpatient service; 🇮🇱 Haifa, Israel

Bnai Zion Medical Center; 🇮🇱 Haifa, Israel