A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494

Study Identifier
M13-845
CT.gov Identifier
NCT01741493
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Rheumatoid Arthritis
    • Study Drug
  • ABT-494
  • Placebo
  • Tofacitinib
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    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.
    Exclusion Criteria:
    * 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).

    Protocol Summary

    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.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 95817
    Miami, Florida, United States, 33136
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 95816
    Cincinnati, Ohio, United States, 45255
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 95815
    Duncansville, Pennsylvania, United States, 16635
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 92153
    Austin, Texas, United States, 78744
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 97177
    Orem, Utah, United States, 84058
    Status
    Not applicable