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Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration

Exposure, Safety and Local Tolerance Study Comparing 3 Routes of Methotrexate (MTX) Administration: Vibex-MTX Device, Subcutaneous (SC)and Intramuscular (IM) in Adult Subjects With Rheumatoid Arthritis

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01737944
Enrollment
38
Registered
2012-11-30
Start date
2011-01-31
Completion date
2011-06-30
Last updated
2014-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

methotrexate injection, subcutaneous, autoinjector

Brief summary

Pharmacokinetics (PK) study

Detailed description

To compare the pharmacokinetic (PK) profiles of methotrexate (MTX) following a subcutaneous (SC) injection of MTX using the Vibex device to that obtained after an SC injection of MTX without using the device and to that obtained after an intramuscular (IM) injection of MTX in adult subjects with rheumatoid arthritis (RA).

Interventions

DRUGMethotrexate (MTX)

Vibex MTX Device

Sponsors

Antares Pharma Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Male or female \>18 years of age with diagnosed Rheumatoid Arthritis(RA).

Exclusion criteria

* Chronic or acute renal disease * Any other clinically significant disease or disorder which, in the opinion of the investigator, might put the subject at risk

Design outcomes

Primary

MeasureTime frameDescription
Bioequivalence Based Upon Dose-Normalized AUC[0-Inf] for MTX24 Hour periodDose-normalized area under the curve from time zero to infinity (AUC\[0-inf\]/Dose) for each treatment
Bioequivalence Based Upon Dose-Normalized AUC[0-24] for MTX24 Hour periodDose-normalized area under the curve from time zero to 24 hours post-dose (AUC\[0-24\]/Dose) for each treatment
Bioequivalence Based Upon Dose-Normalized Cmax for MTX24 Hour periodDose-normalized maximum observed concentration for each treatment

Countries

United States

Participant flow

Recruitment details

Subjects were screened and enrolled at 2 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 patient's dose was the same for the entire study.

Pre-assignment details

The order of Methotrexate (MTX) treatment arms (A-SC injection with Vibex-MTX device, B-SC injection without device and C-IM Injection) were randomly assigned and dosing was separated by interval of atleast 7 days to allow for washout before the next treatment was administered.

Participants by arm

ArmCount
10mg MTX Group
\[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C\]
9
15mg MTX Group
\[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C\]
9
20mg MTX Group
\[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C\]
9
25mg MTX Group
\[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C\]
9
Total36

Baseline characteristics

Characteristic15mg MTX Group20mg MTX Group10mg MTX Group25mg MTX GroupTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
3 Participants2 Participants2 Participants2 Participants9 Participants
Age, Categorical
Between 18 and 65 years
6 Participants7 Participants7 Participants7 Participants27 Participants
Age, Continuous63.4 years
STANDARD_DEVIATION 7.26
60.8 years
STANDARD_DEVIATION 6.18
61.2 years
STANDARD_DEVIATION 10.97
63.0 years
STANDARD_DEVIATION 6.8
62.1 years
STANDARD_DEVIATION 7.76
Region of Enrollment
United States
9 participants9 participants9 participants9 participants36 participants
Sex: Female, Male
Female
5 Participants6 Participants7 Participants7 Participants25 Participants
Sex: Female, Male
Male
4 Participants3 Participants2 Participants2 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
1 / 90 / 92 / 91 / 9
serious
Total, serious adverse events
0 / 90 / 90 / 90 / 9

Outcome results

Primary

Bioequivalence Based Upon Dose-Normalized AUC[0-24] for MTX

Dose-normalized area under the curve from time zero to 24 hours post-dose (AUC\[0-24\]/Dose) for each treatment

Time frame: 24 Hour period

Population: Dose-normalized MTX PK parameter AUC(0-24)/Dose used for comparison

ArmMeasureValue (MEAN)Dispersion
Treatment Arm ABioequivalence Based Upon Dose-Normalized AUC[0-24] for MTX116.60 ng*hr/mL/mgStandard Deviation 40.963
Treatment Arm BBioequivalence Based Upon Dose-Normalized AUC[0-24] for MTX121.08 ng*hr/mL/mgStandard Deviation 39.405
Treatment Arm CBioequivalence Based Upon Dose-Normalized AUC[0-24] for MTX122.63 ng*hr/mL/mgStandard Deviation 40.648
90% CI: [92.32, 100.28]
90% CI: [97.06, 105.4]
Primary

Bioequivalence Based Upon Dose-Normalized AUC[0-Inf] for MTX

Dose-normalized area under the curve from time zero to infinity (AUC\[0-inf\]/Dose) for each treatment

Time frame: 24 Hour period

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Treatment Arm ABioequivalence Based Upon Dose-Normalized AUC[0-Inf] for MTX118.14 ng*hr/mL/mgStandard Deviation 42.3
Treatment Arm BBioequivalence Based Upon Dose-Normalized AUC[0-Inf] for MTX122.63 ng*hr/mL/mgStandard Deviation 40.648
Treatment Arm CBioequivalence Based Upon Dose-Normalized AUC[0-Inf] for MTX116.71 ng*hr/mL/mgStandard Deviation 41.394
90% CI: [92.33, 100.31]
90% CI: [97.17, 105.56]
Primary

Bioequivalence Based Upon Dose-Normalized Cmax for MTX

Dose-normalized maximum observed concentration for each treatment

Time frame: 24 Hour period

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Treatment Arm ABioequivalence Based Upon Dose-Normalized Cmax for MTX21.43 ng/mL/mgStandard Deviation 8.31
Treatment Arm BBioequivalence Based Upon Dose-Normalized Cmax for MTX22.38 ng/mL/mgStandard Deviation 10.263
Treatment Arm CBioequivalence Based Upon Dose-Normalized Cmax for MTX23.37 ng/mL/mgStandard Deviation 7.188
90% CI: [87.93, 106.47]
90% CI: [81.61, 98.78]

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026