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Search / Trial NCT01741493

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

Launched by ABBVIE (PRIOR SPONSOR, ABBOTT) · Dec 3, 2012

Trial Information

Current as of July 24, 2025

Completed

Keywords

Rheumatoid Arthritis Methotrexate Tolerability Pharmacokinetics Safety Tofacitinib

ClinConnect Summary

To assess the safety, tolerability and pharmacokinetics of ABT-494 in healthy volunteers and in patients with rheumatoid arthritis.

Gender

ALL

Eligibility 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).

About Abbvie (Prior Sponsor, Abbott)

AbbVie is a global biopharmaceutical company formed in 2013 as a spinoff from Abbott Laboratories, focusing on the discovery, development, and commercialization of advanced therapies for complex diseases. With a commitment to innovation and patient-centric solutions, AbbVie leverages cutting-edge research and a robust pipeline to address unmet medical needs across various therapeutic areas, including immunology, oncology, and neuroscience. The company's dedication to advancing healthcare is underscored by its collaborative approach, engaging with healthcare professionals, patients, and stakeholders to deliver groundbreaking treatments that improve patient outcomes and quality of life.

Locations

Miami, Florida, United States

Cincinnati, Ohio, United States

Duncansville, Pennsylvania, United States

Austin, Texas, United States

Orem, Utah, United States

Patients applied

0 patients applied

Trial Officials

Steven Jungerwirth, MD

Study Director

AbbVie

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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