Intraarticular Injection of Infliximab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00521963
Recruitment Status : Withdrawn (poor accrual)
First Posted : August 28, 2007
Last Update Posted : June 26, 2015
Bnai Zion Medical Center
Carmel Medical Center
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Arthritis Biological: Intraarticular injection of infliximab Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interventional Study: Administration of Intraarticular Injection of Infliximab in Patients With Inflammatory Arthritis Who Failed Intraarticular Injection of Corticosteroids
Study Start Date : March 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis
Drug Information available for: Infliximab

Arm Intervention/treatment
Experimental: E Biological: Intraarticular injection of infliximab
A single injection of 100 mg of infliximab
Other Name: Remicade

Primary Outcome Measures :
  1. suppression of inflammation [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Amount of systemic absorbtion [ Time Frame: 2,4,8,12weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have non-infectious monoarthritis of the knee and with inadequate response to IA injection of corticosteroids, at least 3 months before enrollment.


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00521963

Bnai Zion Medical Center
Haifa, Israel
Carmel Medical Center and Lin outpatient service
Haifa, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
Bnai Zion Medical Center
Carmel Medical Center
Principal Investigator: Reuven Mader, MD Ha'Emek Medical Center, Afula, Israel