A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-122 in Subjects With Rheumatoid Arthritis

Completed · Phase 1 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of ABT-122 in subjects with Rheumatoid Arthritis.

Key facts

Study ID

NCT01853033

Run by

AbbVie

People needed

19

Starts

2013-07-01

Expected to finish

2014-05-01

Last updated by the study team

2017-11-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Rheumatoid Arthritis (RA) > 3 months.
• On methotrexate (MTX) therapy => 3 months and on a stable dose for at least 4 weeks.
• Except for MTX, must have discontinued all disease-modifying antirheumatic drugs (DMARDs) for at least 3 months or 5 half-lives, whichever is longer.
• Body Mass Index (BMI) is 19 to 38, inclusive.
• Other than RA, subjects should be in good general health.

You may not qualify if…

• Evidence of anti-ABT-122 antibody on a serum sample taken at Screening.
• History of significant allergic reaction; or history of anaphylactic reaction to any agent; or history of major reaction to any IgG containing product.
• History of persistent chronic or active infection(s) requiring hospitalization or treatment with intravenous or oral anti-microbials/antibiotics within the past 30 days.
• History or evidence of active tuberculosis (TB) or the subject has evidence of risk factor for latent TB.
• Subject has any medical condition or illness other than RA that is not well controlled with treatment.

Where it is running

• Site Reference ID/Investigator# 108655 — Lenexa, Kansas, United States
• Site Reference ID/Investigator# 107115 — Raleigh, North Carolina, United States
• Site Reference ID/Investigator# 118964 — Duncansville, Pennsylvania, United States
• Site Reference ID/Investigator# 100780 — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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