A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-122 in Subjects With Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Interventions
- Biological: ABT-122Biological: Placebo
- Registration Number
- NCT01853033
- Lead Sponsor
- AbbVie
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 3 ABT-122 Randomized 6 drug/2 placebo by group Group 2 Placebo Randomized 6 drug/2 placebo by group Group 1 Placebo Randomized 6 drug/2 placebo by group Group 3 Placebo Randomized 6 drug/2 placebo by group Group 1 ABT-122 Randomized 6 drug/2 placebo by group Group 2 ABT-122 Randomized 6 drug/2 placebo by group
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (4)
Site Reference ID/Investigator# 118964
🇺🇸Duncansville, Pennsylvania, United States
Site Reference ID/Investigator# 107115
🇺🇸Raleigh, North Carolina, United States
Site Reference ID/Investigator# 100780
🇺🇸Dallas, Texas, United States
Site Reference ID/Investigator# 108655
🇺🇸Lenexa, Kansas, United States