Rheumatoid ArthritisPhase 1/2NCT01737944

Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration

A Phase 1/2 study testing Methotrexate (MTX) in people with Rheumatoid Arthritis, run by Antares Pharma Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Pharmacokinetics (PK) study Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: Methotrexate (MTX)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteUnited States
Study dates: Jan 2011to Jun 2011
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635

Other trials in United States

About this study

Official title: 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

Pharmacokinetics (PK) study

Read the 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).

Conditions: Rheumatoid Arthritis
Being tested: Methotrexate (MTX)
Keywords: methotrexate injection, subcutaneous, autoinjector
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Methotrexate (MTX)Drug
Also called Device with MTX
Vibex MTX Device

Study groups in NCT01737944
Study group	Role	What they receive
10mg Methotrexate (MTX) Group	Experimental	Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection Receives: Drug: Methotrexate (MTX)
15mg Methotrexate (MTX) Group	Experimental	Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection Receives: Drug: Methotrexate (MTX)
20mg Methotrexate (MTX) Group	Experimental	Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection Receives: Drug: Methotrexate (MTX)
25mg Methotrexate (MTX) Group	Experimental	Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection Receives: Drug: Methotrexate (MTX)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 24 Hour period
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
Measured: 24 Hour period
Bioequivalence Based Upon Dose-Normalized Cmax for MTX
Dose-normalized maximum observed concentration for each treatment
Measured: 24 Hour period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Jun 2011

First posted30 Nov 2012 (estimated)
Study startJan 2011
Primary completionMay 2011
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01737944
Sponsor's protocol ID: MTX-10-001
Status last verified: Jan 2014
First submitted: 27 Nov 2012
Last updated: 25 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01737944
Acronym / sponsor ID: MTX-10-001
Conditions: Rheumatoid Arthritis
Keywords: methotrexate injection, subcutaneous, autoinjector
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Antares Pharma Inc.Industry (pharma, biotech, devices)
Study start: Jan 2011
Primary completion: May 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 30 Nov 2012 (estimated)
Results: Posted 25 Feb 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Pharmacokinetics (PK) study

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
10mg Methotrexate (MTX) Group	Experimental	Drug: Methotrexate (MTX)Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection
15mg Methotrexate (MTX) Group	Experimental	Drug: Methotrexate (MTX)Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection
20mg Methotrexate (MTX) Group	Experimental	Drug: Methotrexate (MTX)Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection
25mg Methotrexate (MTX) Group	Experimental	Drug: Methotrexate (MTX)Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Methotrexate (MTX)Also: Device with MTXVibex MTX Device	Drug	10mg Methotrexate (MTX) Group, 15mg Methotrexate (MTX) Group, 20mg Methotrexate (MTX) Group, 25mg Methotrexate (MTX) Group

Primary outcome

Bioequivalence Based Upon Dose-Normalized AUC[0-Inf] for MTX
Time frame: 24 Hour period
Dose-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 MTX
Time frame: 24 Hour period
Dose-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 MTX
Time frame: 24 Hour period
Dose-normalized maximum observed concentration for each treatment

Results and safety

Results posted to the registry on 25 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
10mg MTX Group	9	9
15mg MTX Group	9	9
20mg MTX Group	9	9
25mg MTX Group	9	9

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

Time frame: 24 Hour period. Mean (Standard Deviation). Unit: ng*hr/mL/mg

Measure	Treatment Arm A n = 36	Treatment Arm B n = 36	Treatment Arm C n = 36
Value	118.14 (42.300)	122.63 (40.648)	116.71 (41.394)

Treatment Arm A vs Treatment Arm B: Test / Reference Ratio: 96.24 (90% CI 92.33 to 100.31)
Treatment Arm A vs Treatment Arm C: Test / Reference Ratio: 101.28 (90% CI 97.17 to 105.56)

Population analysed: 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.

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

Time frame: 24 Hour period. Mean (Standard Deviation). Unit: ng*hr/mL/mg

Measure	Treatment Arm A n = 36	Treatment Arm B n = 36	Treatment Arm C n = 36
Value	116.60 (40.963)	121.08 (39.405)	122.63 (40.648)

Treatment Arm A vs Treatment Arm B: Test / Reference Ratio: 96.22 (90% CI 92.32 to 100.28)
Treatment Arm A vs Treatment Arm C: Test / Reference Ratio: 101.14 (90% CI 97.06 to 105.40)

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

Primary outcome: Bioequivalence Based Upon Dose-Normalized Cmax for MTX

Time frame: 24 Hour period. Mean (Standard Deviation). Unit: ng/mL/mg

Measure	Treatment Arm A n = 36	Treatment Arm B n = 36	Treatment Arm C n = 36
Value	21.43 (8.310)	22.38 (10.263)	23.37 (7.188)

Treatment Arm A vs Treatment Arm B: Test / Reference Ratio: 96.76 (90% CI 87.93 to 106.47)
Treatment Arm A vs Treatment Arm C: Test / Reference Ratio: 89.79 (90% CI 81.61 to 98.78)

Population analysed: 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.

Adverse events

Time frame: The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 36 subjects.. Other adverse events reported at 2.8% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
10mg MTX	0 of 9 (0%)	1 of 9 (11.1%)	Not reported
15mg MTX	0 of 9 (0%)	0 of 9 (0%)	Not reported
20mg MTX	0 of 9 (0%)	2 of 9 (22.2%)	Not reported
25mg MTX	0 of 9 (0%)	1 of 9 (11.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rheumatoid Arthritis

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alan J Kivitz, MD;CPI principal investigator

Altoona Center for Clinical Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Methotrexate (MTX) in people with Rheumatoid Arthritis, run by Antares Pharma Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bioequivalence Based Upon Dose-Normalized AUC[0-Inf] for MTX (time frame: 24 Hour period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01737944.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2014.