Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-122 in Subjects With Rheumatoid Arthritis
Lead Sponsor:
AbbVie
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 randomi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01853033
Start Date
July 1 2013
End Date
May 1 2014
Last Update
November 20 2017
Active Locations (4)
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1
Site Reference ID/Investigator# 108655
Lenexa, Kansas, United States, 66219
2
Site Reference ID/Investigator# 107115
Raleigh, North Carolina, United States, 27612
3
Site Reference ID/Investigator# 118964
Duncansville, Pennsylvania, United States, 16635
4
Site Reference ID/Investigator# 100780
Dallas, Texas, United States, 75231