Phase 4
N=16
Treatment Of Knee Osteoarthritis With Intra-Articular Infliximab
Osteoarthritis of the Knee
Bottom Line
View on ClinicalTrials.gov: NCT01144143 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Change in Cellular Infiltrates From Day 0 to Day 28 — 2; 0; 2; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Infliximab (Drug); Placebo (Drug); Standard of Care: Methylprednisolone acetate (Drug)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Herbert Lindsley, MD
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cellular Infiltrates From Day 0 to Day 28 |
2; 0; 2; 4; 2; 0 | — |
| SECONDARY Change in Joint Effusions From Day 0 to Day 56 Target Knee |
0.3; 0.0; 0.0 | — |
| SECONDARY Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score Target Knee |
-25.9; -9.3; 2.0 | — |
| SECONDARY Change in Levels of Serum IL-6 |
-0.4; 8.1; 5.5 | — |
| SECONDARY Change in Serum CRP Day 0 to Day 56 |
-0.18; -0.15; 0.08 | — |
| SECONDARY Change in Serum SAA Levels Day 0 to Day 56 |
-1.0; -715.6; -1580.2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Adults ≥ age 35 but ≤ age 85.
- Painful knees for 3-60 months.
- VAS joint pain score greater than 30 mm (scale 0-100)
- Knee radiograph showing minimal to moderate change (early OA).
- No NSAID therapy for at least one week.
- Have the capacity to understand and sign an informed consent form.
- Gender: Male or female
- Women must be postmenopausal (no menstrual period for a minimum of 1 year) or surgically sterilized and have a negative serum pregnancy test on entry in the study. Men must agree to use adequate birth control during the study for 6 months after the infusion of study agent.
- Men and women of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) for the duration of the study and should continue such precautions for 6 months after receiving the last infusion.
- The screening laboratory test results must meet the following criteria
- WBC (white blood cell count): >3.5/uL
- Hemoglobin: > 10 gm/dl
- Platelets: > 100,000/ul
- Serum Creatinine: 3 months prior to screening).
- Have a concomitant diagnosis or history of congestive heart failure Grade III-IV.
- Have had a nontuberculous mycobacterial infection or opportunistic infection (e.g., cytomegalovirus, Pneumocystis carinii, and aspergillosis) within 6 months prior to screening.
Data sourced from ClinicalTrials.gov (NCT01144143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.