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.
Drug: JNJ-38518168 / MTX
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Locations near you
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Full eligibility criteria for NCT01450982
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
All locations for NCT01450982
United States (5)
Anniston, Alabama, United States
Daytona Beach, Florida, United States
Duncansville, Pennsylvania, United States
Dallas, Texas, United States
Miramar, Florida, United States
View full eligibility
Tris trial is registered with FDA with number: NCT01450982. The sponsor of the trial is Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and it is looking for 20 volunteers for the current phase.
Official trial title: A Study to Investigate the Effects of JNJ-38518168 on Methotrexate Pharmacokinetics in Rheumatoid Arthritis Participants on a Stable Methotrexate Dose
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