Rheumatoid Arthritis (RA)Phase 1NCT01871961
Evaluation of Patient Performance Using the Metoject Device for Subcutaneous Injection in Rheumatoid Arthritis (RA)Patient
A Phase 1 study testing Methotrexate (Metoject® prefilled pen) in people with Rheumatoid Arthritis (RA), run by medac GmbH at 1 site in United States.
Trial summary
To evaluate the human factors/usability of Rheumatoid Arthritis (RA) patients with the Metoject® prefilled pen (including a label comprehension assessment and a device robustness evaluation). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Methotrexate (Metoject® prefilled pen)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to May 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Is a suitable candidate for treatment with Methotrexate for Rheumatoid Arthritis
- Male or female patient who is 16 years of age or older
Who cannot join
- Is a female patient who is pregnant, trying to become pregnant, or breast feeding, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control during the study and at least 6 months thereafter
- Has any history of hypersensitivity to the investigational medicinal product
- Has a history of or current inflammatory arthritis or rheumatic autoimmune disease other than Rheumatoid Arthritis (RA)
- Is unable to comprehend written labeling and training materials
Trial locations and contacts
1 site in 1 country.
United States1 site
Rheumatology Arthitis & Rheumatic Care center
South Miami, Florida, 33143
About this study
Official title: Evaluation of Rheumatoid Arthritis Patient Performance Using the Metoject® Prefilled Pen (Methotrexate 50 mg/mL, Prefilled Pen) for Subcutaneous Injection and Subsequent Pharmacokinetic Assessment of Drug Delivery
To evaluate the human factors/usability of Rheumatoid Arthritis (RA) patients with the Metoject® prefilled pen (including a label comprehension assessment and a device robustness evaluation).
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Methotrexate (Metoject® prefilled pen)
- 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 (Metoject® prefilled pen)Drug
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate | Experimental | Not described Receives: Drug: Methotrexate (Metoject® prefilled pen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the human factors/usability of Rheumatoid Arthritis (RA) patients with the Metoject® prefilled pen (including a label comprehension assessment and a device robustness evaluation).
Questionnaires to assess the comprehension of the label (instruction for use of the prefilled pen) and device robustness evaluation after usage of the prefilled pen
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startOct 2012
- Primary completionFeb 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- medac GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871961
- Sponsor's protocol ID
- MC-MTX.15/HF
- Status last verified
- Mar 2015
- First submitted
- 14 May 2013
- Last updated
- 17 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Rheumatoid Arthritis Patient Performance Using the Metoject® Prefilled Pen (Methotrexate 50 mg/mL, Prefilled Pen) for Subcutaneous Injection and Subsequent Pharmacokinetic Assessment of Drug Delivery
- ClinicalTrials.gov ID
- NCT01871961
- Acronym / sponsor ID
- MC-MTX.15/HF
- Conditions
- Rheumatoid Arthritis (RA)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- medac GmbHIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- Oct 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the human factors/usability of Rheumatoid Arthritis (RA) patients with the Metoject® prefilled pen (including a label comprehension assessment and a device robustness evaluation).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methotrexate | Experimental | Drug: Methotrexate (Metoject® prefilled pen) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Is a suitable candidate for treatment with Methotrexate for Rheumatoid Arthritis
- Male or female patient who is 16 years of age or older
Key exclusion criteria (4 listed)
- Is a female patient who is pregnant, trying to become pregnant, or breast feeding, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control during the study and at least 6 months thereafter
- Has any history of hypersensitivity to the investigational medicinal product
- Has a history of or current inflammatory arthritis or rheumatic autoimmune disease other than Rheumatoid Arthritis (RA)
- Is unable to comprehend written labeling and training materials
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 (Metoject® prefilled pen) | Drug | Methotrexate |
Primary outcome
To evaluate the human factors/usability of Rheumatoid Arthritis (RA) patients with the Metoject® prefilled pen (including a label comprehension assessment and a device robustness evaluation).
Time frame: 1 year
Questionnaires to assess the comprehension of the label (instruction for use of the prefilled pen) and device robustness evaluation after usage of the prefilled pen
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Methotrexate (Metoject® prefilled pen) in people with Rheumatoid Arthritis (RA), run by medac GmbH 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 2 inclusion and 4 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 17 Mar 2015. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the human factors/usability of Rheumatoid Arthritis (RA) patients with the Metoject® prefilled pen (including a label comprehension assessment and a device robustness evaluation). (time frame: 1 year). 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 17 Mar 2015.