A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-122 in Subjects With Rheumatoid Arthritis
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 11/22/2017 |
Start Date: | July 2013 |
End Date: | May 2014 |
A Study in Patients With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ABT-122
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of
ABT-122 in subjects with Rheumatoid Arthritis.
ABT-122 in subjects with Rheumatoid Arthritis.
This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose
study. Twenty-four subjects with Rheumatoid Arthritis will be selected to participate.
Subjects will be randomized to receive either ABT-122 or placebo. ABT-122 or placebo will be
administered as subcutaneous (under the skin) injections in three dosing groups.
study. Twenty-four subjects with Rheumatoid Arthritis will be selected to participate.
Subjects will be randomized to receive either ABT-122 or placebo. ABT-122 or placebo will be
administered as subcutaneous (under the skin) injections in three dosing groups.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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