A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494
Completed · Phase 1 · Has a placebo group
Conditions studied: Rheumatoid Arthritis
In brief
This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study in healthy volunteers, multiple dose study in patients with rheumatoid arthritis and multiple dose study in healthy volunteers.
Key facts
- Study ID
- NCT01741493
- Run by
- AbbVie (prior sponsor, Abbott)
- People needed
- 67
- Starts
- 2012-11-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2017-11-20
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy Volunteers:
- Male and female subjects 18 to 55 years of age, inclusive.
- Subject is judged to be in good general health.
- Rheumatoid Arthritis Patients:
- Male and female patients 18 to 75 years of age, inclusive.
- Subject has a diagnosis of rheumatoid arthritis for at least six months.
- Subject has been on methotrexate therapy for at least three months and on a stable dose for at least four weeks.
You may not qualify if…
- History or evidence of active or latent tuberculosis.
- History or significant allergic reaction to any drug.
- Use of known strong CYP3A and CYP2D6 inhibitors and CYP3A inducers within 21 days or within 5 half-lives of the respective medication, whichever is longer.
- Current or expected need for oral intake of at least 10 mg prednisone per day or equivalent corticosteroid therapy.
- History of acute inflammatory joint disease of different origin other than rheumatoid arthritis (rheumatoid arthritis patients).
Where it is running
- Site Reference ID/Investigator# 95817 — Miami, Florida, United States
- Site Reference ID/Investigator# 95816 — Cincinnati, Ohio, United States
- Site Reference ID/Investigator# 95815 — Duncansville, Pennsylvania, United States
- Site Reference ID/Investigator# 92153 — Austin, Texas, United States
- Site Reference ID/Investigator# 97177 — Orem, Utah, United States
Full record on ClinicalTrials.gov
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