Rheumatoid Arthritis (RA)Phase 2NCT01618968

Comparison of Methotrexate (MTX) and the VIBEX™ MTX Device

A Phase 2 study testing MTX in people with Rheumatoid Arthritis (RA), 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

Relative Bioavailability Comparison study Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis (RA)
What is being tested?: MTX
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 1 siteUnited States
Study dates: May 2012to Aug 2012
Phase: Phase 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 patients ≥18 years of age, diagnosed with Rheumatoid Arthritis

Who cannot join

Pregnant females
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 the Relative Bioavailability of Oral Methotrexate and the VIBEX™ MTX Device in Adult Subjects With Rheumatoid Arthritis

Relative Bioavailability Comparison study

Read the detailed description

A Phase 2, Open-Label, Randomized, 3-Way Crossover Study to Compare the Relative Bioavailability of Oral Methotrexate and the VIBEX™ MTX Device in Adult Subjects With Rheumatoid Arthritis

Conditions: Rheumatoid Arthritis (RA)
Being tested: MTX
Medical subject headings: Arthritis, Rheumatoid

What participants receive

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

MTXDrug
Also called Commercially available 2.5 mg MTX oral tablets, VIBEX MTX
- Treatment A - 1 dose (4, 6, 8 or 10 tablets respectively to make up 10 mg, 15 mg, 20 mg or 25 mg MTX - per subject's dose group)
- Treatment B - SC injection using VIBEX MTX device into abdomen (VIBEX MTX device pre-filled with 10 mg, 15 mg, 20 mg or 25 mg MTX)
- Treatment C - SC injection using VIBEX MTX device into thigh (VIBEX MTX device pre-filled with 10 mg, 15 mg, 20 mg or 25 mg MTX)

Study groups in NCT01618968
Study group	Role	What they receive
10 mg Methotrexate (MTX)	Experimental	MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned. Receives: Drug: MTX
15 mg MTX	Experimental	MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned. Receives: Drug: MTX
20 mg MTX	Experimental	MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned. Receives: Drug: MTX
25 mg MTX	Experimental	MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned. Receives: Drug: MTX

What is being measured

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

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
Dose-Normalized AUC[0-24] for MTX
Dose-normalized area under the curve from time zero to 24 hours (AUC[0-24]/Dose) for each treatment
Measured: 24 Hour period
Dose-Normalized Cmax for MTX
Dose-normalized maximum observed concentration (Cmax) 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.

May 2012Aug 2012

First posted14 Jun 2012 (estimated)
Study startMay 2012
Primary completionAug 2012
Study completionAug 2012

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Rheumatoid Arthritis (RA)Studies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01618968
Sponsor's protocol ID: MTX-11-003
Status last verified: May 2014
First submitted: 4 Jun 2012
Last updated: 19 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Schiff MH, Jaffe JS, Freundlich B. Head-to-head, randomised, crossover study of oral versus subcutaneous methotrexate in patients with rheumatoid arthritis: drug-exposure limitations of oral methotrexate at doses >/=15 mg may be overcome with subcutaneous administration. Ann Rheum Dis. 2014 Aug;73(8):1549-51. doi: 10.1136/annrheumdis-2014-205228. Epub 2014 Apr 12.
PubMed 24728329

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 (RA) trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exposure, Safety and Local Tolerance Study Comparing the Relative Bioavailability of Oral Methotrexate and the VIBEX™ MTX Device in Adult Subjects With Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT01618968
Acronym / sponsor ID: MTX-11-003
Conditions: Rheumatoid Arthritis (RA)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Antares Pharma Inc.Industry (pharma, biotech, devices)
Study start: May 2012
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 14 Jun 2012 (estimated)
Results: Posted 8 May 2014

Clinical summary

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

Relative Bioavailability Comparison study

Detailed description

A Phase 2, Open-Label, Randomized, 3-Way Crossover Study to Compare the Relative Bioavailability of Oral Methotrexate and the VIBEX™ MTX Device in Adult Subjects With Rheumatoid Arthritis

Study design

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

Arm	Type	Receives
10 mg Methotrexate (MTX)	Experimental	Drug: MTXMTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.
15 mg MTX	Experimental	Drug: MTXMTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.
20 mg MTX	Experimental	Drug: MTXMTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.
25 mg MTX	Experimental	Drug: MTXMTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.

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 patients ≥18 years of age, diagnosed with Rheumatoid Arthritis

Key exclusion criteria (2 listed)

Pregnant females
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
MTXAlso: Commercially available 2.5 mg MTX oral tablets, VIBEX MTX* Treatment A - 1 dose (4, 6, 8 or 10 tablets respectively to make up 10 mg, 15 mg, 20 mg or 25 mg MTX - per subject's dose group) * Treatment B - SC injection using VIBEX MTX device into abdomen (VIBEX MTX device pre-filled with 10 mg, 15 mg, 20 mg or 25 mg MTX) * Treatment C - SC injection using VIBEX MTX device into thigh (VIBEX MTX device pre-filled with 10 mg, 15 mg, 20 mg or 25 mg MTX)	Drug	10 mg Methotrexate (MTX), 15 mg MTX, 20 mg MTX, 25 mg MTX

Primary outcome

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
Dose-Normalized AUC[0-24] for MTX
Time frame: 24 Hour period
Dose-normalized area under the curve from time zero to 24 hours (AUC[0-24]/Dose) for each treatment
Dose-Normalized Cmax for MTX
Time frame: 24 Hour period
Dose-normalized maximum observed concentration (Cmax) for each treatment

Results and safety

Results posted to the registry on 8 May 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	13	12
15mg MTX	12	12
20mg MTX	12	12
25mg MTX	12	11

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

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

Measure	Treatment A n = 47	Treatment B n = 49	Treatment C n = 47
Value	109.47 (39.19)	140.84 (46.66)	136.45 (46.675)

Treatment A vs Treatment B: Test / Reference Ratio: 127.99 (90% CI 121.61 to 134.70)
Treatment A vs Treatment C: Test / Reference Ratio: 125.48 (90% CI 119.43 to 131.84)
Treatment B vs Treatment C: Test / Reference ratio: 101.85 (90% CI 99.41 to 104.36)

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: Dose-Normalized AUC[0-24] for MTX

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

Measure	Treatment A n = 47	Treatment B n = 49	Treatment C n = 47
Value	107.64 (37.732)	137.88 (44.513)	133.78 (44.406)

Treatment A vs Treatment B: Test / Reference Ratio: 127.65 (90% CI 121.28 to 134.36)
Treatment A vs Treatment C: Test / Reference ratio: 125.20 (90% CI 119.16 to 131.55)
Treatment B vs Treatment C: Test / Reference Ratio: 101.82 (90% CI 99.39 to 104.31)

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: Dose-Normalized Cmax for MTX

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

Measure	Treatment A n = 47	Treatment B n = 49	Treatment C n = 47
Value	22.697 (7.496)	21.935 (8.243)	18.436 (5.321)

Treatment A vs Treatment B: Test / Reference ratio: 94.83 (90% CI 86.42 to 104.06)
Treatment A vs Treatment C: Test / Reference Ratio: 82.12 (90% CI 76.16 to 88.55)
Treatment B vs Treatment C: Test / Reference Ratio: 115.63 (90% CI 108.83 to 122.86)

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 49 subjects.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
10mg MTX	0 of 13 (0%)	2 of 13 (15.4%)	Not reported
15mg MTX	1 of 12 (8.3%)	0 of 12 (0%)	Not reported
20mg MTX	0 of 12 (0%)	1 of 12 (8.3%)	Not reported
25mg MTX	1 of 12 (8.3%)	0 of 12 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24728329Schiff MH, Jaffe JS, Freundlich B. Head-to-head, randomised, crossover study of oral versus subcutaneous methotrexate in patients with rheumatoid arthritis: drug-exposure limitations of oral methotrexate at doses >/=15 mg may be overcome with subcutaneous administration. Ann Rheum Dis. 2014 Aug;73(8):1549-51. doi: 10.1136/annrheumdis-2014-205228. Epub 2014 Apr 12.

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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 2 study testing MTX in people with Rheumatoid Arthritis (RA), 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 19 May 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 phase mean?

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 8 May 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?

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 NCT01618968, which also lists 1 linked publication.

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 19 May 2014.