Intraarticular Injection of Infliximab

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by HaEmek Medical Center, Israel.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Bnai Zion Medical Center
Carmel Medical Center
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00521963
First received: August 17, 2007
Last updated: August 27, 2007
Last verified: August 2007
  Purpose

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 Intervention Phase
Arthritis
Biological: Intraarticular injection of infliximab
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

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

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

Estimated Enrollment: 40
Arms Assigned Interventions
Experimental: E Biological: Intraarticular injection of infliximab
A single injection of 100 mg of infliximab
Other Name: Remicade

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521963

Contacts
Contact: Reuven Mader, MD 972-4-6494354 Mader_r@clalit.org.il

Locations
Israel
Bnai Zion Medical Center Not yet recruiting
Haifa, Israel
Contact: Itzchak Rosner, MD    972-4-6420056    rosneri@techunix.technion.ac.il   
Principal Investigator: Itzchak Rosner, MD         
Carmel Medical Center and Lin outpatient service Not yet recruiting
Haifa, Israel
Contact: Devi Zisman, MD    972-0506265526    devyzi@clalit.org.il   
Principal Investigator: Devi Zisman, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Bnai Zion Medical Center
Carmel Medical Center
Investigators
Principal Investigator: Reuven Mader, MD Ha'Emek Medical Center, Afula, Israel
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00521963     History of Changes
Other Study ID Numbers: 0088-07-EMC
Study First Received: August 17, 2007
Last Updated: August 27, 2007
Health Authority: Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
Intraarticular injection
Infliximab

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases
Infliximab
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Gastrointestinal Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014