Treatment Of Knee Osteoarthritis With Intra-Articular Infliximab

NCT01144143 | Completed Phase 4 Results DMC

• 1 other identifier: 10702
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis of the Knee

Keywords

Mild to moderate osteoarthritis of the knee

Outcome Measures

Primary Outcomes (1)

• Change in Cellular Infiltrates From Day 0 to Day 28

  Cellular infiltration scored 0 to 3

  Day 0 to Day 28

Secondary Outcomes (5)

• Change in Joint Effusions From Day 0 to Day 56 Target Knee

  Change from Day 0 to Day 56

• Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score Target Knee

  Change from Day 0 to Day 56

• Change in Levels of Serum IL-6

  Change from Day 0 to Day 56

• Change in Serum CRP Day 0 to Day 56

  Day 0 to Day 56

• Change in Serum SAA Levels Day 0 to Day 56

  Day 0 to Day 56

Study Arms (3)

Infliximab

EXPERIMENTAL

Drug: Infliximab

Salt Water

PLACEBO COMPARATOR

Drug: Placebo

Methylprednisolone acetate

ACTIVE COMPARATOR

Drug: Standard of Care: Methylprednisolone acetate

Interventions

Infliximab DRUG

the study drug will be injected into the joint through a needle

Infliximab

Placebo DRUG

the placebo will be injected into the joint through a needle

Salt Water

Standard of Care: Methylprednisolone acetate DRUG

Methylprednisolone acetate will be injected into the joint through a needle

Methylprednisolone acetate

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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: \< 1.8
• SGPT (ALT - alanine aminotransferase) \<3 times ULN

You may not qualify if:

• Moderate to Severe OA, as determined by severe joint space narrowing (Kellgren grade IV) (7) in medial and lateral compartments
• Insulin-dependent diabetes mellitus.
• Systemic inflammatory illness, e.g. rheumatoid arthritis.
• Intra-articular injections within 3 months.
• Prior treatment with infliximab or other anti-TNF drug.
• Acute injury to knees (\< 2 weeks)
• Women who are pregnant, nursing, or planning pregnancy within 6 months after the last infusion (this includes father's who plan on fathering a child within 6 months after their last infusion).
• Have had any previous treatment with monoclonal antibodies or antibody fragments.
• Documentation of a positive test for hepatitis B surface antigen or hepatitis C.
• Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results.
• Have a known history of serious infections (e.g., hepatitis, pneumonia, or pyelonephritis) in the previous 3 months.
• Have or have had an opportunistic infection (e.g., herpes zoster \[shingles\], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening
• Currently receiving Coumadin, Ticlid, Plavix, or heparin/heparin analog within 7 days prior to synovial biopsy.
• Currently receiving aspirin within 7 days prior to synovial biopsy.
• Have a chest radiograph at screening that shows evidence of malignancy or infection.

Sponsors & Collaborators

• Herbert Lindsley, MD: lead
• Centocor, Inc.: collaborator

Study Sites (1)

University Of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Herbert Lindsley
• Organization: University of Kansas Medical Center

HLINDSLE@kumc.edu

(913) 588-3402

Study Officials

• Herbert Lindsley, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 10, 2010
• First Posted: June 15, 2010
• Study Start: July 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: February 8, 2018
• Results First Posted: February 8, 2018

Record last verified: 2018-01

Locations

US (1)