Rheumatoid Arthritis (RA)Phase 2NCT01618955
Actual Human Use of Methotrexate (MTX) Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device
A Phase 2 study testing VIBEX MTX in people with Rheumatoid Arthritis (RA), run by Antares Pharma Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the usability of the VIBEX MTX device for SC self-injection of methotrexate. 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?
- VIBEX MTX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jul 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
About this study
Official title: Phase 2, Multi-Center, Open-Label, Single-Dose, Single Arm, In-Clinic Study to Evaluate the Actual Human Use of Methotrexate Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device in Adult Patients With Rheumatoid Arthritis.
The purpose of this study is to assess the usability of the VIBEX MTX device for SC self-injection of methotrexate.
Read the detailed description
Primary objective:
- To assess the safe usability of the VIBEX MTX device for subcutaneous (SC) self-injection of methotrexate (MTX) in adult patients with rheumatoid arthritis (RA) after standardized training by site personnel and review of written instructions
Secondary objectives:
- To evaluate the reliability and robustness of the VIBEX MTX device
- To evaluate the safety and local tolerance of an SC self-injection of MTX using the VIBEX MTX device
- To evaluate the effectiveness and ease of use of the VIBEX MTX device patient education tools for SC self-injection
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- VIBEX 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.
VIBEX MTXDevice
Also called prefilled autoinjector device
Self-administration of Single Dose of SC MTX using Vibex MTX 10 mg, 15 mg, 20 mg or 25 mg Device
| Study group | Role | What they receive |
|---|---|---|
| VIBEX MTX | Active comparator | VIBEX MTX dose based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status Receives: Device: VIBEX MTX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safe Usability of the VIBEX MTX Device for Subcutaneous (SC) Self-injection With Methotrexate (MTX) in Adult Patients With Rheumatoid Arthritis (RA) as Demonstrated by Successful Self-Injection
A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device.
The Assessment of Essential Tasks Questionnaire was completed by site personnel documenting a patient's performance of essential self-injection steps, including the following:
- SC self-injection was administered by the patient
- SC self-injection was intentional
- self-injection was administered in an appropriate location on the abdomen
- patient removed cap marked "1"
- patient removed cap marked "2"
- patient held device at injection site for 3 seconds
- patient confirmed that the window was obstructed
Measured: 24 hours
Secondary outcomes (3)
Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools
A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device
- Ease of use Questionnaire was completed by patients immediately after self-injection
- Training confirmation questionnaire was completed by patients after the training and then reviewed with PI or site coordinator
Measured: 24 hours
Safety of Vibex MTX Device
A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device
Injection site assessments were done 0.25 hour, 1 hour, 6 hours and 24 hours after an injection and reported as the following:
- Erythema - 0 = None
- Erythema - 1 = Very slight, barely perceptible
- Erythema - 2 = Obvious, but well defined
- Erythema - 3 = Moderate to severe
- Erythema - 4 = Severe
Measured: 24 hours
Tolerance of Vibex MTX Device (Injection Site Pain Severity as Reported by Patient on VAS Scale - 0 mm = no Pain to 100 mm = Very Severe Pain)
A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device.
Visual Analog Scale assessment of injection site pain was reported by patients on 100 mm line immediately after an injection and at 24 hours after injection.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2012
- Study completionJul 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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antares Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan J Kivitz, MD;CPI, Principal investigator, Altoona Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618955
- Sponsor's protocol ID
- MTX-11-002
- Status last verified
- Mar 2014
- First submitted
- 4 Jun 2012
- Last updated
- 30 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Multi-Center, Open-Label, Single-Dose, Single Arm, In-Clinic Study to Evaluate the Actual Human Use of Methotrexate Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device in Adult Patients With Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT01618955
- Acronym / sponsor ID
- MTX-11-002
- Conditions
- Rheumatoid Arthritis (RA)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Antares Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 14 Jun 2012 (estimated)
- Results
- Posted 30 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the usability of the VIBEX MTX device for SC self-injection of methotrexate.
Detailed description
Primary objective:
- To assess the safe usability of the VIBEX MTX device for subcutaneous (SC) self-injection of methotrexate (MTX) in adult patients with rheumatoid arthritis (RA) after standardized training by site personnel and review of written instructions
Secondary objectives:
- To evaluate the reliability and robustness of the VIBEX MTX device
- To evaluate the safety and local tolerance of an SC self-injection of MTX using the VIBEX MTX device
- To evaluate the effectiveness and ease of use of the VIBEX MTX device patient education tools for SC self-injection
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VIBEX MTX | Active comparator | Device: VIBEX MTXVIBEX MTX dose based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status |
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 |
|---|---|---|
| VIBEX MTXAlso: prefilled autoinjector deviceSelf-administration of Single Dose of SC MTX using Vibex MTX 10 mg, 15 mg, 20 mg or 25 mg Device | Device | VIBEX MTX |
Primary outcome
Safe Usability of the VIBEX MTX Device for Subcutaneous (SC) Self-injection With Methotrexate (MTX) in Adult Patients With Rheumatoid Arthritis (RA) as Demonstrated by Successful Self-Injection
Time frame: 24 hours
A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device. The Assessment of Essential Tasks Questionnaire was completed by site personnel documenting a patient's performance of essential self-injection steps, including the following: 1. SC self-injection was administered by the patient 2. SC self-injection was intentional 3. self-injection was administered in an appropriate location on the abdomen 4. patient removed cap marked "1" 5. patient removed cap marked "2" 6. patient held device at injection site for 3 seconds 7. patient confirmed that the window was obstructed
3 secondary outcomes
Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools
Time frame: 24 hours
Safety of Vibex MTX Device
Time frame: 24 hours
Tolerance of Vibex MTX Device (Injection Site Pain Severity as Reported by Patient on VAS Scale - 0 mm = no Pain to 100 mm = Very Severe Pain)
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 VIBEX 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 30 Apr 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 30 Apr 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?
Safe Usability of the VIBEX MTX Device for Subcutaneous (SC) Self-injection With Methotrexate (MTX) in Adult Patients With Rheumatoid Arthritis (RA) as Demonstrated by Successful Self-Injection (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2014.