NCT01144143

Treatment Of Knee Osteoarthritis With Intra-Articular Infliximab

Single Center, Randomized, Double-Blind, Placebo-Controlled Treatment Of Knee Osteoarthritis With Intra-Articular Infliximab

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Herbert Lindsley, MD · Academic / Other
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if an anti-inflammatory drug, called infliximab, will reduce inflammation in the synovial lining in patients with an early stage of osteoarthritis of the knee. It will also help determine if the study medication decreases the accumulation of synovial fluid and prevents cartilage breakdown.

Detailed description

This is an unbalanced randomized, double-blind pilot study of Infliximab (100 mg), placebo (100 mg) and Methylprednisolone acetate (80 mg). A total of 16 subjects will be randomized; 8 subjects will be randomized to receive infliximab, 4 subjects will be randomized to receive placebo and 4 additional subjects will be randomized to receive Methylprednisolone acetate. Subjects will be seen at screening, day 0, day 14, day 28 and day 56. After study drug injection at day 0, patients will return for follow-up visits at approximately 2 weeks, 1 and 2 months in order to obtain clinical endpoint measures for a total of 10 weeks. Outcome measures include blood tests, MRI, ultrasound, synovial lining tissue biopsy questionnaires and adverse events.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	Infliximab	the study drug will be injected into the joint through a needle
DRUG	Placebo	the placebo will be injected into the joint through a needle
DRUG	Standard of Care: Methylprednisolone acetate	Methylprednisolone acetate will be injected into the joint through a needle

Timeline

• Start date: 2007-07-01
• Primary completion: 2010-12-01
• Completion: 2011-01-01
• First posted: 2010-06-15
• Last updated: 2018-02-08
• Results posted: 2018-02-08

Locations

1 site across 1 country: United States