A Dose Range Finding Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis in Spite of Treatment With Methotrexate
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Rheumatoid Arthritis
In brief
The purpose of this dose range finding study is to assess the effectiveness, safety and tolerability of JNJ-38518168 at doses of 3, 10, and 30 mg/d compared with placebo in patients with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy.
Key facts
- Study ID
- NCT01679951
- Run by
- Janssen Research & Development, LLC
- People needed
- 272
- Starts
- 2012-10-31
- Expected to finish
- 2014-07-03
- Last updated by the study team
- 2019-03-18
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Has had rheumatoid arthritis for at least 6 months prior to the date of signing the informed consent at screening
- Must be positive for either anti-cyclic citrullinated peptide antibody or rheumatoid factor in serum at screening
- Must have active rheumatoid arthritis (at least 6 swollen and 6 tender joints using a 66/68 joint count at the time of screening and at baseline and Serum C reactive protein greater than or equal to 0.80 mg/dL at the time of screening
- Has been treated with and tolerated methotrexate treatment at dosages from 10 to 25 mg/week inclusive, for a minimum of 6 months with stable dose for at least 8 weeks prior to the date of signing the informed consent at screening
You may not qualify if…
- Has inflammatory diseases other than rheumatoid arthritis, including but not limited to adult onset Still's disease, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, and Lyme disease that might confound the evaluation of the benefit of study agent therapy
- Has 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
- Has ever received any approved or investigational biologic agent for a rheumatoid indication
- Has been treated with any nonbiologic disease modifying antirheumatic drugs within 4 weeks prior to the first administration of study agent
Where it is running
- Study site — Gilbert, Arizona, United States
- Study site — Covina, California, United States
- Study site — Palm Harbor, Florida, United States
- Study site — Granger, Indiana, United States
- Study site — Frederick, Maryland, United States
- Study site — Freehold, New Jersey, United States
- Study site — Charlotte, North Carolina, United States
- Study site — Charleston, South Carolina, United States
- Study site — Buenos Aires, Argentina
- Study site — San Miguel de Tucumán, Argentina
- Study site — Osorno X Region, Chile
- Study site — Santiago, Chile
- Study site — Santiago - Macul, Chile
- Study site — Viña del Mar, Chile
- Study site — Barranquilla, Colombia
- Study site — Bogotá, Colombia
- Study site — Bucaramanga, Colombia
- Study site — Cali, Colombia
- Study site — Medellín, Colombia
- Study site — Hlučín, Czechia
- Study site — Ostrava, Czechia
- Study site — Prague, Czechia
- Study site — Slaný, Czechia
- Study site — Zlín, Czechia
- Study site — Huntsville, Alabama, United States
Full record on ClinicalTrials.gov
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