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Interventional Study: Administration of Intraarticular Injection of Infliximab in Patients With Inflammatory Arthritis Who Failed Intraarticular Injection of Corticosteroids


Phase 2/Phase 3
18 Years
75 Years
Not Enrolling
Both
Arthritis

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Trial Information

Interventional Study: Administration of Intraarticular Injection of Infliximab in Patients With Inflammatory Arthritis Who Failed Intraarticular Injection of Corticosteroids


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

suppression of inflammation

Outcome Time Frame:

12 weeks

Principal Investigator

Reuven Mader, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ha'Emek Medical Center, Afula, Israel

Authority:

Israel: Ministry of Health

Study ID:

0088-07-EMC

NCT ID:

NCT00521963

Start Date:

Completion Date:

Related Keywords:

  • Arthritis
  • Intraarticular injection
  • Infliximab
  • Arthritis

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