Rheumatoid Arthritis
Conditions
Keywords
Tolerability, Immunogenicity, Safety, Rheumatoid Arthritis, Pharmacokinetics
Brief summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of ABT-122 in subjects with Rheumatoid Arthritis.
Detailed description
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.
Interventions
BIOLOGICALABT-122
Injection
BIOLOGICALPlacebo
Placebo Injection
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Adverse Events | From date of first dose of ABT-122 until 42 days after the last dose of ABT-122 | Collect all adverse events at each visit |
| Change in physical exam including vital signs | From date of first dose of ABT-122 until 42 days after last dose of ABT-122 | Blood pressure, pulse and body temperature |
| Change in clinical lab test results | From date of first dose of ABT-122 until 42 days after the last dose of ABT-122 | Hematology, Chemistry, and Urinalysis |
| Change in Electrocardiogram (ECG) results | From subject's baseline (prior to subject's first dose) and up to 168 hours following the last dose of study drug | ECGs done in triplicate |
| Determination of pharmacokinetic (PK) parameters | Prior to first dose up to 42 days after the last dose of ABT-122 | Cmax, Tmax, AUC, elimination rate constant and half-life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of anti-drug anti-bodies (ADA) of ABT-122 | Prior to each dose and up until 42 days after the last dose of ABT-122 | Measurement of ADA |
Countries
United States
Outcome results
None listed