Rheumatoid ArthritisPhase 1NCT01450982
A Study to Investigate How JNJ-38518168 May Affect the Plasma Levels of Methotrexate in Rheumatoid Arthritis Participants
A Phase 1 study testing JNJ-38518168 / MTX in people with Rheumatoid Arthritis, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the effects of JNJ-38518168 on the pharmacokinetics (how the body handles a drug) of methotrexate in participants with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- JNJ-38518168 / MTX
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2011to Oct 2011
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a body mass index (BMI) between 18 and 38 kg/m2 inclusive, and a body weight between 50-110 kg, inclusive
- Have a diagnosis of Rheumatoid Arthritis functional class I-III for at least 3 months prior to Screening
- Have been treated with and tolerated oral MTX treatment for a minimum of 3 months prior to screening and must have been on a once-weekly stable MTX dose (taken as a single dose) (between 7.5-25 mg/week) for a minimum of 1 month
- Participants may continue on stable non-steroid anti-inflammatory drugs and corticosteroid background therapy for RA or stable therapies for other conditions as prescribed by physician, provided that the doses of such therapy are stable for at least 1 month prior to screening and will remain unchanged for the entire study duration.
Who cannot join
- Have current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive or uncontrolled in the study doctor's opinion
- Have been treated with a monoclonal antibody for RA or have had a serious infection with 2 weeks of the study treatment period.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Study site
Anniston, Alabama
Study site
Dallas, Texas
Study site
Daytona Beach, Florida
Study site
Duncansville, Pennsylvania
About this study
Official title: A Study to Investigate the Effects of JNJ-38518168 on Methotrexate Pharmacokinetics in Rheumatoid Arthritis Participants on a Stable Methotrexate Dose
The purpose of this study is to evaluate the effects of JNJ-38518168 on the pharmacokinetics (how the body handles a drug) of methotrexate in participants with rheumatoid arthritis.
Read the detailed description
This is an open-label (physician and participant will know the name of the assigned drug), multi-center, non-randomized, drug/drug interaction study of JNJ-38518168 in participants with rheumatoid arthritis (RA) on a stable oral methotrexate (MTX) dose (7.5-25 mg). The treatment phase will last 16 days. Participants will be housed in the clinic for dosing and study procedures from Day -1 to Day 2 and again from Day 14 to Day 16. Participants completing treatment will have a follow-up visit between Days 22 and 25. Participants who discontinue the study prematurely will complete the Day 22 to 25 follow-up procedures at the time of discontinuation or as soon as possible thereafter. The duration of participation in the study for an individual participant will be up to 7 weeks (including screening). Participant safety will be monitored. Day 1: A single oral dose of the participant's weekly methotrexate dose. Days 2-15: Weekly MTX co-administered with two 50-mg capsules of JNJ-38518168, administered daily.
- Conditions
- Rheumatoid Arthritis
- Being tested
- JNJ-38518168 / MTX
- Keywords
- Rheumatoid Arthritis, JNJ-38518168, Methotrexate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-38518168 / MTXDrug
Day 1: MTX: Route=oral use, single dose of participant's weekly MTX dose
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | JNJ-38518168 / MTX Day 1: MTX: Route=oral use single dose of participant's weekly MTX dose Days 2-15: MTX: Route=oral use single dose of participant's weekly MTX dose and of JNJ-38518168 Type=exact unit=mg number=100 form=capsule route=oral use administered daily. Receives: Drug: JNJ-38518168 / MTX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood levels of methotrexate
To assess the effect of multiple doses of JNJ-38518168 on blood levels of methotrexate
Measured: Up to approximately 7 weeks
Secondary outcomes (4)
Blood levels of JNJ-38518168
To assess the effect of methotrexate on the blood levels of JNJ-38518168
Measured: Up to approximately 7 weeks
The number of participants with adverse events
Measured: Up to approximately 7 weeks
Clinical laboratory tests
Blood and urine tests
Measured: Up to approximately 7 weeks
Electrocardiograms
Measured: Up to approximately 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2011 (estimated)
- Study startJun 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450982
- Sponsor's protocol ID
- CR018655
- Other IDs
- 38518168ARA1001
- Status last verified
- May 2013
- First submitted
- 13 Jun 2011
- Last updated
- 6 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Effects of JNJ-38518168 on Methotrexate Pharmacokinetics in Rheumatoid Arthritis Participants on a Stable Methotrexate Dose
- ClinicalTrials.gov ID
- NCT01450982
- Acronym / sponsor ID
- CR018655
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, JNJ-38518168, Methotrexate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Study completion
- Oct 2011 (actual)
- First posted
- 13 Oct 2011 (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.
The purpose of this study is to evaluate the effects of JNJ-38518168 on the pharmacokinetics (how the body handles a drug) of methotrexate in participants with rheumatoid arthritis.
Detailed description
This is an open-label (physician and participant will know the name of the assigned drug), multi-center, non-randomized, drug/drug interaction study of JNJ-38518168 in participants with rheumatoid arthritis (RA) on a stable oral methotrexate (MTX) dose (7.5-25 mg). The treatment phase will last 16 days. Participants will be housed in the clinic for dosing and study procedures from Day -1 to Day 2 and again from Day 14 to Day 16. Participants completing treatment will have a follow-up visit between Days 22 and 25. Participants who discontinue the study prematurely will complete the Day 22 to 25 follow-up procedures at the time of discontinuation or as soon as possible thereafter. The duration of participation in the study for an individual participant will be up to 7 weeks (including screening). Participant safety will be monitored. Day 1: A single oral dose of the participant's weekly methotrexate dose. Days 2-15: Weekly MTX co-administered with two 50-mg capsules of JNJ-38518168, administered daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: JNJ-38518168 / MTXJNJ-38518168 / MTX Day 1: MTX: Route=oral use single dose of participant's weekly MTX dose Days 2-15: MTX: Route=oral use single dose of participant's weekly MTX dose and of JNJ-38518168 Type=exact unit=mg number=100 form=capsule route=oral use administered daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a body mass index (BMI) between 18 and 38 kg/m2 inclusive, and a body weight between 50-110 kg, inclusive
- Have a diagnosis of Rheumatoid Arthritis functional class I-III for at least 3 months prior to Screening
- Have been treated with and tolerated oral MTX treatment for a minimum of 3 months prior to screening and must have been on a once-weekly stable MTX dose (taken as a single dose) (between 7.5-25 mg/week) for a minimum of 1 month
- Participants may continue on stable non-steroid anti-inflammatory drugs and corticosteroid background therapy for RA or stable therapies for other conditions as prescribed by physician, provided that the doses of such therapy are stable for at least 1 month prior to screening and will remain unchanged for the entire study duration.
Key exclusion criteria (2 listed)
- Have current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive or uncontrolled in the study doctor's opinion
- Have been treated with a monoclonal antibody for RA or have had a serious infection with 2 weeks of the study treatment period.
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 |
|---|---|---|
| JNJ-38518168 / MTXDay 1: MTX: Route=oral use, single dose of participant's weekly MTX dose | Drug | 001 |
Primary outcome
Blood levels of methotrexate
Time frame: Up to approximately 7 weeks
To assess the effect of multiple doses of JNJ-38518168 on blood levels of methotrexate
4 secondary outcomes
Blood levels of JNJ-38518168
Time frame: Up to approximately 7 weeks
The number of participants with adverse events
Time frame: Up to approximately 7 weeks
Clinical laboratory tests
Time frame: Up to approximately 7 weeks
Electrocardiograms
Time frame: Up to approximately 7 weeks
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 6 May 2013.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-38518168 / MTX in people with Rheumatoid Arthritis, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 4 sites 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 4 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 6 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Blood levels of methotrexate (time frame: Up to approximately 7 weeks). 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 6 May 2013.