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JNJ-38518168/ MTX

Phase 1

Rheumatoid Arthritis | Small molecule | Immunology |Johnson & Johnson|Last Updated: May 6, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

JNJ-38518168/ MTX · 1 trial · 1 indication

Phase 1 1
NCT01450982A Study to Investigate How JNJ-38518168 May Affect the Plasma Levels of Methotrexate in Rheumatoid Arthritis ParticipantsRheumatoid Arthritis
COMPLETED20 Analytics
PHASE1COMPLETED
A Study to Investigate How JNJ-38518168 May Affect the Plasma Levels of Methotrexate in Rheumatoid Arthritis Participants
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Blood levels of methotrexate
Up to approximately 7 weeks

To assess the effect of multiple doses of JNJ-38518168 on blood levels of methotrexate

Secondary Endpoints

Blood levels of JNJ-38518168
Up to approximately 7 weeks
The number of participants with adverse events
Up to approximately 7 weeks
Clinical laboratory tests
Up to approximately 7 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
001EXPERIMENTALJNJ-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.

Interventions

NameTypeDescription
JNJ-38518168 / MTXDRUGDay 1: MTX: Route=oral use, single dose of participant's weekly MTX dose
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * 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 f...

Countries:United States
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Frequently asked questions about JNJ-38518168/ MTX

What is JNJ-38518168 used for?

JNJ-38518168 is an investigational small molecule being studied for the treatment of moderate to severe plaque-type psoriasis and uncontrolled, persistent asthma. It has also been evaluated in clinical trials involving patients with rheumatoid arthritis and hepatic impairment.

Who makes JNJ-38518168?

JNJ-38518168 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ.

What phase is JNJ-38518168 in?

JNJ-38518168 is in Phase 2 clinical development. It has completed Phase 2 trials in patients with moderate to severe plaque-type psoriasis and in adults with uncontrolled, persistent asthma. The drug remains investigational and is not approved for any use.

What clinical trials has JNJ-38518168 been in?

JNJ-38518168 has been studied in several completed trials. NCT02295865 evaluated its safety and efficacy in psoriasis. NCT01823016 studied it in adults with uncontrolled, persistent asthma. NCT01450982 examined its effect on methotrexate levels in rheumatoid arthritis, and NCT01863784 assessed its pharmacokinetics in patients with hepatic impairment.

Is JNJ-38518168 the same as Toreforant?

Yes, JNJ-38518168 is also known as Toreforant. In clinical trial NCT02295865, the study of JNJ-38518168 in participants with moderate to severe plaque-type psoriasis, the drug is referred to as Toreforant (JNJ-38518168).

What is the development status of JNJ-38518168 in asthma?

JNJ-38518168 has completed a Phase 2 trial in symptomatic adult participants with uncontrolled, persistent asthma. This trial, NCT01823016, enrolled 166 participants across the United States, Canada, France, Germany, Israel, and the United Kingdom. The trial is completed, and the drug remains investigational.