Trial Outcomes & Findings for A Study to Evaluate the Effectiveness of Infliximab and Changes in Hand and Wrist Magnetic Resonance Imaging (MRI) in Participants With Active Rheumatoid Arthritis (RA) (P08136) (NCT NCT01313520)
NCT ID: NCT01313520
Last Updated: 2017-05-10
Results Overview
Dynamic Contrast Enhanced (DCE) Magnetic Resonance Imaging (MRI) was performed on one hand at baseline, and then at treatment week 14 to measure the rate constant of transfer of contrast (Ktrans).
COMPLETED
PHASE2
61 participants
Baseline and week 14
2017-05-10
Participant Flow
Participant milestones
| Measure |
Infliximab
3 mg/kg of Infliximab intravenous infusion
|
Placebo
saline via intravenous infusion
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
31
|
|
Overall Study
COMPLETED
|
30
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Effectiveness of Infliximab and Changes in Hand and Wrist Magnetic Resonance Imaging (MRI) in Participants With Active Rheumatoid Arthritis (RA) (P08136)
Baseline characteristics by cohort
| Measure |
Infliximab
n=30 Participants
3 mg/kg of Infliximab intravenous infusion
|
Placebo
n=31 Participants
saline via intravenous infusion
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.3 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
50.1 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
50.2 years
STANDARD_DEVIATION 10.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 14Population: Participants treated with infliximab or placebo
Dynamic Contrast Enhanced (DCE) Magnetic Resonance Imaging (MRI) was performed on one hand at baseline, and then at treatment week 14 to measure the rate constant of transfer of contrast (Ktrans).
Outcome measures
| Measure |
Infliximab
n=30 Participants
3 mg/kg of Infliximab intravenous infusion
|
Placebo
n=31 Participants
saline via intravenous infusion
|
|---|---|---|
|
Change From Baseline in the Volume Transfer Rate From the Blood Plasma to the Enhancing Synovium (Ktrans)
|
-0.2 min ^-1
Interval -0.3 to -0.1
|
0.1 min ^-1
Interval 0.0 to 0.2
|
SECONDARY outcome
Timeframe: Baseline and week 14Population: Participants treated with Infliximab or Placebo
ACR20 requires that both tender and swollen joint counts improve by at least 20% from baseline, as well as a 20% improvement in at least 3 other core measures from the following: pain, patient's and physician's global assessment, physical disability and C-reactive protein (CRP).
Outcome measures
| Measure |
Infliximab
n=30 Participants
3 mg/kg of Infliximab intravenous infusion
|
Placebo
n=31 Participants
saline via intravenous infusion
|
|---|---|---|
|
Percentage of Responders With a 20% Improvement From Baseline in American College of Rheumatology (ACR) Responder Criteria for Tender and Swollen Joints (ACR20).
|
56.7 percentage of responders
Interval 41.9 to 70.4
|
32.3 percentage of responders
Interval 20.3 to 47.0
|
SECONDARY outcome
Timeframe: Baseline and week 14Population: Participants treated with Infliximab or placebo
ACR50 requires that both tender and swollen joint counts improve by at least 50% from baseline, as well as a 50% improvement in at least 3 other core measures from the following: pain, patient's and physician's global assessment, physical disability and CRP.
Outcome measures
| Measure |
Infliximab
n=30 Participants
3 mg/kg of Infliximab intravenous infusion
|
Placebo
n=31 Participants
saline via intravenous infusion
|
|---|---|---|
|
Percentage of Responders With a 50% Improvement From Baseline in American College of Rheumatology (ACR) Responder Criteria for Tender and Swollen Joints (ACR50).
|
20.0 percentage of responders
Interval 10.7 to 34.2
|
0 percentage of responders
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and Week 14Population: Participants treated with Infliximab or placebo
Clinical disease activity score (DAS28 CRP) is a composite index of the following: number of tender joints (28 joint count), number of swollen joints (28 joint count), Patient Global Assessment of Disease Status (GADP) on a 100 mm visual analog scale (VAS) and concentration of CRP. Ktrans is the volume transfer rate from the blood plasma to the enhancing synovium. The individual endpoints are standardized using z-scores, then the z-scores are averaged to create a composite endpoint by use of O'Brien's global statistic.
Outcome measures
| Measure |
Infliximab
n=30 Participants
3 mg/kg of Infliximab intravenous infusion
|
Placebo
n=31 Participants
saline via intravenous infusion
|
|---|---|---|
|
Change From Baseline in Standardized Z-scores of Composite Endpoint Consisting of Clinical Disease Activity Measure DAS28 CRP + Ktrans.
|
-0.8 Z-score
95% Confidence Interval 0.3 • Interval -1.3 to -0.3
|
0.8 Z-score
95% Confidence Interval 0.2 • Interval 0.3 to 1.2
|
SECONDARY outcome
Timeframe: Baseline and Week 14Population: Participants treated with Infliximab or placebo
DAS28 CRP is a composite index of the following: number of tender joints (28 joint count), number of swollen joints (28 joint count), GADP on a 100 mm VAS and concentration of CRP. RAMRIS Synovitis is an ordinal scoring system of hand synovitis that is scored from 0 to 3 in 8 locations, ranging from 0 to 24 total. RAMRIS Osteitis is an ordinal scoring system of hand osteitis that is scored from 0 to 3 in 25 locations, ranging from 0 to 75 total. The individual endpoints are standardized using z-scores, then the z-scores are averaged to create a composite endpoint by use of O'Brien's global statistic.
Outcome measures
| Measure |
Infliximab
n=30 Participants
3 mg/kg of Infliximab intravenous infusion
|
Placebo
n=31 Participants
saline via intravenous infusion
|
|---|---|---|
|
Change From Baseline in Standardized Z-scores of Composite Endpoint Consisting of Clinical Disease Activity Measure DAS28 CRP + Rheumatoid Arthritis MRI Score (RAMRIS) Synovitis + RAMRIS Osteitis.
|
-0.7 Z-score
95% Confidence Interval 0.3 • Interval -1.3 to -0.2
|
0.8 Z-score
95% Confidence Interval 0.2 • Interval 0.2 to 1.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 14Population: Participants treated with infliximab or placebo
DAS28 CRP is a composite index of the following: number of tender joints (28 joint count), number of swollen joints (28 joint count), GADP on a 100 mm VAS and concentration of serum CRP. Scores can range from 2-10; with higher values corresponding to higher disease activity, and lower values to better outcomes.
Outcome measures
| Measure |
Infliximab
n=30 Participants
3 mg/kg of Infliximab intravenous infusion
|
Placebo
n=31 Participants
saline via intravenous infusion
|
|---|---|---|
|
Change From Baseline in DAS28 CRP.
|
-1.8 units on a scale
95% Confidence Interval 0.18 • Interval -2.2 to -1.5
|
-0.8 units on a scale
95% Confidence Interval 0.18 • Interval -1.2 to -0.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 14Population: Participants treated with infliximab or placebo
RAMRIS Synovitis is an ordinal scoring system of hand synovitis that is scored from 0 to 3 in 8 locations. The scores can range from 0 to 24, with higher values corresponding to higher disease activity, and lower values to better outcomes.
Outcome measures
| Measure |
Infliximab
n=30 Participants
3 mg/kg of Infliximab intravenous infusion
|
Placebo
n=31 Participants
saline via intravenous infusion
|
|---|---|---|
|
Change From Baseline in RAMRIS Synovitis.
|
-2.30 units on a scale
Standard Deviation 4.25 • Interval 0.64 to 1.55
|
0.24 units on a scale
Standard Deviation 1.98
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 14Population: Participants treated with infliximab or placebo. One participant in the placebo group missing a baseline value was not included in the analysis.
RAMRIS Osteitis is an ordinal scoring system of hand osteitis that is scored from 0 to 3 in 25 locations. The scores can range from 0 to 75, with higher values corresponding to higher disease activity, and lower values to better outcomes.
Outcome measures
| Measure |
Infliximab
n=30 Participants
3 mg/kg of Infliximab intravenous infusion
|
Placebo
n=30 Participants
saline via intravenous infusion
|
|---|---|---|
|
Change From Baseline in RAMRIS Osteitis.
|
-3.10 units on a scale
Standard Deviation 5.04 • Interval -2.0 to -1.5
|
0.48 units on a scale
Standard Deviation 3.22 • Interval -1.0 to -0.5
|
Adverse Events
Infliximab
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Infliximab
n=30 participants at risk
3 mg/kg of Infliximab intravenous infusion
|
Placebo
n=31 participants at risk
saline via intravenous infusion
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
6.7%
2/30 • Number of events 2
|
0.00%
0/31
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/30
|
6.5%
2/31 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
13.3%
4/30 • Number of events 4
|
19.4%
6/31 • Number of events 6
|
|
Nervous system disorders
Headache
|
6.7%
2/30 • Number of events 2
|
0.00%
0/31
|
Additional Information
Vice President, Late Stage Development Group Leader
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agrees to provide to sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor has the right to review and comment on publications, abstracts, slides and manuscripts and on the data analysis and presentation.
- Publication restrictions are in place
Restriction type: OTHER