Trial Outcomes & Findings for Treatment Of Knee Osteoarthritis With Intra-Articular Infliximab (NCT NCT01144143)
NCT ID: NCT01144143
Last Updated: 2018-02-08
Results Overview
Cellular infiltration scored 0 to 3
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
16 participants
Primary outcome timeframe
Day 0 to Day 28
Results posted on
2018-02-08
Participant Flow
Participant milestones
| Measure |
Infliximab
Investigational (Infliximab) - 100mg The study drug will be injected into the joint through a needle
|
Salt Water
Placebo (Salt Water) - 10 ml Placebo solution will be injected into the joint through a needle
|
Methylprednisolone Acetate
Methylprednisolone Acetate (Standard of Care: MPA) - Standard of Care: MPA 80mg injected into the joint through a needle
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
4
|
4
|
|
Overall Study
COMPLETED
|
8
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment Of Knee Osteoarthritis With Intra-Articular Infliximab
Baseline characteristics by cohort
| Measure |
Infliximab
n=8 Participants
Investigational (Infliximab) - 100mg The study drug will be injected into the joint through a needle
|
Salt Water
n=4 Participants
Placebo (Salt Water) - 10 ml Placebo solution will be injected into the joint through a needle
|
Methylprednisolone Acetate
n=4 Participants
Methylprednisolone Acetate (Standard of Care: MPA) - Standard of Care: MPA 80mg injected into the joint through a needle
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Number
n=5 Participants
|
0 Number
n=7 Participants
|
0 Number
n=5 Participants
|
0 Number
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Number
n=5 Participants
|
0 Number
n=7 Participants
|
0 Number
n=5 Participants
|
0 Number
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Number
n=5 Participants
|
0 Number
n=7 Participants
|
0 Number
n=5 Participants
|
0 Number
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Number
n=5 Participants
|
1 Number
n=7 Participants
|
1 Number
n=5 Participants
|
5 Number
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Number
n=5 Participants
|
3 Number
n=7 Participants
|
3 Number
n=5 Participants
|
11 Number
n=4 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Number
n=5 Participants
|
0 Number
n=7 Participants
|
0 Number
n=5 Participants
|
0 Number
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Number
n=5 Participants
|
0 Number
n=7 Participants
|
0 Number
n=5 Participants
|
0 Number
n=4 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
16 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 28Population: In the MPA arm, one subject was excluded from the analysis because their biopsy sample was of insufficient quantity to be processed in the lab.
Cellular infiltration scored 0 to 3
Outcome measures
| Measure |
Infliximab
n=8 Participants
Investigational (Infliximab) - 100mg The study drug will be injected into the joint through a needle
|
Salt Water
n=4 Participants
Placebo (Salt Water) - 10 ml Placebo solution will be injected into the joint through a needle
|
Methylprednisolone Acetate
n=3 Participants
Methylprednisolone Acetate (Standard of Care: MPA) - Standard of Care: MPA 80mg injected into the joint through a needle
|
|---|---|---|---|
|
Change in Cellular Infiltrates From Day 0 to Day 28
Decreased cellularity
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Change in Cellular Infiltrates From Day 0 to Day 28
Increased cellularity
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Change in Cellular Infiltrates From Day 0 to Day 28
Unchanged cellularity
|
2 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Change from Day 0 to Day 56Outcome calculated based on Physician observation of joint swelling from 0-3. A score of 0 = no effusion,1 = positive "bulge," 2 = moderate effusion, 3 = tense effusion. The outcome represents the change in means between the two time points.
Outcome measures
| Measure |
Infliximab
n=8 Participants
Investigational (Infliximab) - 100mg The study drug will be injected into the joint through a needle
|
Salt Water
n=4 Participants
Placebo (Salt Water) - 10 ml Placebo solution will be injected into the joint through a needle
|
Methylprednisolone Acetate
n=4 Participants
Methylprednisolone Acetate (Standard of Care: MPA) - Standard of Care: MPA 80mg injected into the joint through a needle
|
|---|---|---|---|
|
Change in Joint Effusions From Day 0 to Day 56 Target Knee
|
0.3 units on a scale
Standard Deviation 0.5
|
0.0 units on a scale
Standard Deviation 0.0
|
0.0 units on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Change from Day 0 to Day 56The WOMAC questionnaire is used to evaluate the condition of patients with osteoarthritis. Patients answer questions based on how they are feeling. The questionnaire has a total of 24 questions which deal with pain, stiffness and physical function. Participants are asked to respond to how difficult it is for them to do/complete an activity. There is a total possible score of 96. A score of 0 equals no difficulty completing any of the 24 activities. A score of 96 would indicate extreme difficulty with all activities.
Outcome measures
| Measure |
Infliximab
n=8 Participants
Investigational (Infliximab) - 100mg The study drug will be injected into the joint through a needle
|
Salt Water
n=4 Participants
Placebo (Salt Water) - 10 ml Placebo solution will be injected into the joint through a needle
|
Methylprednisolone Acetate
n=4 Participants
Methylprednisolone Acetate (Standard of Care: MPA) - Standard of Care: MPA 80mg injected into the joint through a needle
|
|---|---|---|---|
|
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score Target Knee
|
-25.9 units on a scale
Standard Deviation 18.1
|
-9.3 units on a scale
Standard Deviation 27.2
|
2.0 units on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Change from Day 0 to Day 56Outcome measures
| Measure |
Infliximab
n=8 Participants
Investigational (Infliximab) - 100mg The study drug will be injected into the joint through a needle
|
Salt Water
n=4 Participants
Placebo (Salt Water) - 10 ml Placebo solution will be injected into the joint through a needle
|
Methylprednisolone Acetate
n=4 Participants
Methylprednisolone Acetate (Standard of Care: MPA) - Standard of Care: MPA 80mg injected into the joint through a needle
|
|---|---|---|---|
|
Change in Levels of Serum IL-6
|
-0.4 pg/ml
Standard Deviation 2.0
|
8.1 pg/ml
Standard Deviation 13.0
|
5.5 pg/ml
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Day 0 to Day 56Serum measure of systemic inflammation
Outcome measures
| Measure |
Infliximab
n=8 Participants
Investigational (Infliximab) - 100mg The study drug will be injected into the joint through a needle
|
Salt Water
n=4 Participants
Placebo (Salt Water) - 10 ml Placebo solution will be injected into the joint through a needle
|
Methylprednisolone Acetate
n=4 Participants
Methylprednisolone Acetate (Standard of Care: MPA) - Standard of Care: MPA 80mg injected into the joint through a needle
|
|---|---|---|---|
|
Change in Serum CRP Day 0 to Day 56
|
-0.18 mg/dl
Standard Deviation 0.37
|
-0.15 mg/dl
Standard Deviation 0.30
|
0.08 mg/dl
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: Day 0 to Day 56Serum Amyloid A
Outcome measures
| Measure |
Infliximab
n=8 Participants
Investigational (Infliximab) - 100mg The study drug will be injected into the joint through a needle
|
Salt Water
n=4 Participants
Placebo (Salt Water) - 10 ml Placebo solution will be injected into the joint through a needle
|
Methylprednisolone Acetate
n=4 Participants
Methylprednisolone Acetate (Standard of Care: MPA) - Standard of Care: MPA 80mg injected into the joint through a needle
|
|---|---|---|---|
|
Change in Serum SAA Levels Day 0 to Day 56
|
-1.0 ug/ml
Standard Deviation 2256
|
-715.6 ug/ml
Standard Deviation 1043
|
-1580.2 ug/ml
Standard Deviation 4819
|
Adverse Events
Infliximab
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Salt Water
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Methylprednisolone Acetate
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Infliximab
n=8 participants at risk
Investigational (Infliximab) - 100mg The study drug will be injected into the joint through a needle
|
Salt Water
n=4 participants at risk
Placebo (Salt Water) - 10 ml Placebo solution will be injected into the joint through a needle
|
Methylprednisolone Acetate
n=4 participants at risk
Methylprednisolone Acetate (Standard of Care: MPA) - Standard of Care: MPA 80mg injected into the joint through a needle
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pulled Muscle in Back
|
12.5%
1/8 • Number of events 1 • Patients were observed for adverse events for 70 days (from screening (Day -14) through Day 56).
Event information collected via subject reporting at visits.
|
0.00%
0/4 • Patients were observed for adverse events for 70 days (from screening (Day -14) through Day 56).
Event information collected via subject reporting at visits.
|
0.00%
0/4 • Patients were observed for adverse events for 70 days (from screening (Day -14) through Day 56).
Event information collected via subject reporting at visits.
|
|
Musculoskeletal and connective tissue disorders
Pulling and Popping Sensation in Knee
|
12.5%
1/8 • Number of events 1 • Patients were observed for adverse events for 70 days (from screening (Day -14) through Day 56).
Event information collected via subject reporting at visits.
|
0.00%
0/4 • Patients were observed for adverse events for 70 days (from screening (Day -14) through Day 56).
Event information collected via subject reporting at visits.
|
0.00%
0/4 • Patients were observed for adverse events for 70 days (from screening (Day -14) through Day 56).
Event information collected via subject reporting at visits.
|
|
Musculoskeletal and connective tissue disorders
Swelling in Left Knee Following Biopsy
|
12.5%
1/8 • Number of events 1 • Patients were observed for adverse events for 70 days (from screening (Day -14) through Day 56).
Event information collected via subject reporting at visits.
|
0.00%
0/4 • Patients were observed for adverse events for 70 days (from screening (Day -14) through Day 56).
Event information collected via subject reporting at visits.
|
0.00%
0/4 • Patients were observed for adverse events for 70 days (from screening (Day -14) through Day 56).
Event information collected via subject reporting at visits.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Number of events 1 • Patients were observed for adverse events for 70 days (from screening (Day -14) through Day 56).
Event information collected via subject reporting at visits.
|
0.00%
0/4 • Patients were observed for adverse events for 70 days (from screening (Day -14) through Day 56).
Event information collected via subject reporting at visits.
|
25.0%
1/4 • Number of events 1 • Patients were observed for adverse events for 70 days (from screening (Day -14) through Day 56).
Event information collected via subject reporting at visits.
|
|
Musculoskeletal and connective tissue disorders
Pain in Left knee
|
12.5%
1/8 • Number of events 1 • Patients were observed for adverse events for 70 days (from screening (Day -14) through Day 56).
Event information collected via subject reporting at visits.
|
0.00%
0/4 • Patients were observed for adverse events for 70 days (from screening (Day -14) through Day 56).
Event information collected via subject reporting at visits.
|
25.0%
1/4 • Number of events 1 • Patients were observed for adverse events for 70 days (from screening (Day -14) through Day 56).
Event information collected via subject reporting at visits.
|
|
Musculoskeletal and connective tissue disorders
Pain at Biopsy Site
|
0.00%
0/8 • Patients were observed for adverse events for 70 days (from screening (Day -14) through Day 56).
Event information collected via subject reporting at visits.
|
25.0%
1/4 • Number of events 1 • Patients were observed for adverse events for 70 days (from screening (Day -14) through Day 56).
Event information collected via subject reporting at visits.
|
0.00%
0/4 • Patients were observed for adverse events for 70 days (from screening (Day -14) through Day 56).
Event information collected via subject reporting at visits.
|
|
Musculoskeletal and connective tissue disorders
Twisted Left knee
|
0.00%
0/8 • Patients were observed for adverse events for 70 days (from screening (Day -14) through Day 56).
Event information collected via subject reporting at visits.
|
25.0%
1/4 • Number of events 1 • Patients were observed for adverse events for 70 days (from screening (Day -14) through Day 56).
Event information collected via subject reporting at visits.
|
0.00%
0/4 • Patients were observed for adverse events for 70 days (from screening (Day -14) through Day 56).
Event information collected via subject reporting at visits.
|
Additional Information
Dr. Herbert Lindsley
University of Kansas Medical Center
Phone: (913) 588-3402
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place