Trial Outcomes & Findings for Comparison of Methotrexate (MTX) and the VIBEX™ MTX Device (NCT NCT01618968)
NCT ID: NCT01618968
Last Updated: 2014-05-19
Results Overview
Dose-normalized area under the curve from time zero to infinity (AUC\[0-inf\]/Dose) for each treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
24 Hour period
Results posted on
2014-05-19
Participant Flow
Subjects were screened and enrolled at 4 sites in the US. Approximately equal number of subjects on 10 mg, 15 mg, 20 mg and 25 mg doses were recruited. The dose group was determined by the Investigator based on subject's current therapeutic regimen of MTX and disease status. The subject's dose was the same for the entire study
MTX was administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C within the same dose group. Treatments were administered at a 7 day interval (On study days 1, 8 and 15)
Participant milestones
| Measure |
10mg MTX
\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\]
|
15mg MTX
\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\]
|
20mg MTX
\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\]
|
25mg MTX
\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\]
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
12
|
12
|
|
Overall Study
Received Treatment A
|
12
|
12
|
12
|
11
|
|
Overall Study
Received Treatment B
|
13
|
12
|
12
|
12
|
|
Overall Study
Received Treatment C
|
12
|
12
|
12
|
11
|
|
Overall Study
COMPLETED
|
12
|
12
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
10mg MTX
\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\]
|
15mg MTX
\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\]
|
20mg MTX
\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\]
|
25mg MTX
\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\]
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Comparison of Methotrexate (MTX) and the VIBEX™ MTX Device
Baseline characteristics by cohort
| Measure |
10mg MTX
n=13 Participants
\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\]
|
15mg MTX
n=12 Participants
\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\]
|
20mg MTX
n=12 Participants
\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\]
|
25mg MTX
n=12 Participants
\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\]
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 12.51 • n=99 Participants
|
63.4 years
STANDARD_DEVIATION 7.49 • n=107 Participants
|
60.0 years
STANDARD_DEVIATION 10.40 • n=206 Participants
|
59.0 years
STANDARD_DEVIATION 11.53 • n=7 Participants
|
61.4 years
STANDARD_DEVIATION 10.53 • n=31 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
31 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
12 participants
n=99 Participants
|
11 participants
n=107 Participants
|
10 participants
n=206 Participants
|
11 participants
n=7 Participants
|
44 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
1 participants
n=7 Participants
|
5 participants
n=31 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
12 participants
n=107 Participants
|
12 participants
n=206 Participants
|
12 participants
n=7 Participants
|
49 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 24 Hour periodPopulation: The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.
Dose-normalized area under the curve from time zero to infinity (AUC\[0-inf\]/Dose) for each treatment
Outcome measures
| Measure |
Treatment A
n=47 Participants
Oral Methotrexate (MTX) Tablets
|
Treatment B
n=49 Participants
SC injection of Vibex MTX into the Abdomen
|
Treatment C
n=47 Participants
SC injection of Vibex MTX into the Thigh
|
|---|---|---|---|
|
Dose-Normalized AUC[0-Inf] for MTX
|
109.47 ng*hr/mL/mg
Standard Deviation 39.19
|
140.84 ng*hr/mL/mg
Standard Deviation 46.66
|
136.45 ng*hr/mL/mg
Standard Deviation 46.675
|
PRIMARY outcome
Timeframe: 24 Hour periodPopulation: The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.
Dose-normalized area under the curve from time zero to 24 hours (AUC\[0-24\]/Dose) for each treatment
Outcome measures
| Measure |
Treatment A
n=47 Participants
Oral Methotrexate (MTX) Tablets
|
Treatment B
n=49 Participants
SC injection of Vibex MTX into the Abdomen
|
Treatment C
n=47 Participants
SC injection of Vibex MTX into the Thigh
|
|---|---|---|---|
|
Dose-Normalized AUC[0-24] for MTX
|
107.64 ng*hr/mL/mg
Standard Deviation 37.732
|
137.88 ng*hr/mL/mg
Standard Deviation 44.513
|
133.78 ng*hr/mL/mg
Standard Deviation 44.406
|
PRIMARY outcome
Timeframe: 24 Hour periodPopulation: The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.
Dose-normalized maximum observed concentration (Cmax) for each treatment
Outcome measures
| Measure |
Treatment A
n=47 Participants
Oral Methotrexate (MTX) Tablets
|
Treatment B
n=49 Participants
SC injection of Vibex MTX into the Abdomen
|
Treatment C
n=47 Participants
SC injection of Vibex MTX into the Thigh
|
|---|---|---|---|
|
Dose-Normalized Cmax for MTX
|
22.697 ng/mL/mg
Standard Deviation 7.496
|
21.935 ng/mL/mg
Standard Deviation 8.243
|
18.436 ng/mL/mg
Standard Deviation 5.321
|
Adverse Events
10mg MTX
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
15mg MTX
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
20mg MTX
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
25mg MTX
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
10mg MTX
n=13 participants at risk
\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\]
|
15mg MTX
n=12 participants at risk
\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\]
|
20mg MTX
n=12 participants at risk
\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\]
|
25mg MTX
n=12 participants at risk
\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\]
|
|---|---|---|---|---|
|
Cardiac disorders
Sick Sinus Syndrome (15 mg Vibex MTX SC Thigh)
|
0.00%
0/13 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 49 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
8.3%
1/12 • Number of events 1 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 49 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
0.00%
0/12 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 49 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
0.00%
0/12 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 49 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
|
Cardiac disorders
Myocardial Infarction (25 mg Vibex MTX SC Abdomen)
|
0.00%
0/13 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 49 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
0.00%
0/12 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 49 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
0.00%
0/12 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 49 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
8.3%
1/12 • Number of events 1 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 49 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
Other adverse events
| Measure |
10mg MTX
n=13 participants at risk
\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\]
|
15mg MTX
n=12 participants at risk
\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\]
|
20mg MTX
n=12 participants at risk
\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\]
|
25mg MTX
n=12 participants at risk
\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\]
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea (20 mg MTX Oral)
|
0.00%
0/13 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 49 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
0.00%
0/12 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 49 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
8.3%
1/12 • Number of events 1 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 49 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
0.00%
0/12 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 49 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
|
General disorders
Fatigue (10 mg Vibex MTX SC Thigh)
|
7.7%
1/13 • Number of events 1 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 49 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
0.00%
0/12 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 49 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
0.00%
0/12 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 49 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
0.00%
0/12 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 49 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis (10 mg Vibex MTX SC Abdomen)
|
7.7%
1/13 • Number of events 1 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 49 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
0.00%
0/12 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 49 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
0.00%
0/12 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 49 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
0.00%
0/12 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 49 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
Additional Information
Jonathan Jaffe, MD; Vice President Clinical Development
Antares Pharma Inc.
Phone: 609-359-3020
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60