A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-122 in Subjects With Rheumatoid Arthritis
A Study in Patients With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ABT-122
1 other identifier
interventional
19
1 country
4
Brief Summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of ABT-122 in subjects with Rheumatoid Arthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 rheumatoid-arthritis
Started Jul 2013
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2013
CompletedFirst Posted
Study publicly available on registry
May 14, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedNovember 20, 2017
June 1, 2014
10 months
May 10, 2013
November 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Number of participants with Adverse Events
Collect all adverse events at each visit
From date of first dose of ABT-122 until 42 days after the last dose of ABT-122
Change in physical exam including vital signs
Blood pressure, pulse and body temperature
From date of first dose of ABT-122 until 42 days after last dose of ABT-122
Change in clinical lab test results
Hematology, Chemistry, and Urinalysis
From date of first dose of ABT-122 until 42 days after the last dose of ABT-122
Change in Electrocardiogram (ECG) results
ECGs done in triplicate
From subject's baseline (prior to subject's first dose) and up to 168 hours following the last dose of study drug
Determination of pharmacokinetic (PK) parameters
Cmax, Tmax, AUC, elimination rate constant and half-life
Prior to first dose up to 42 days after the last dose of ABT-122
Secondary Outcomes (1)
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
Study Arms (3)
Group 1
EXPERIMENTALRandomized 6 drug/2 placebo by group
Group 2
EXPERIMENTALRandomized 6 drug/2 placebo by group
Group 3
EXPERIMENTALRandomized 6 drug/2 placebo by group
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (4)
Site Reference ID/Investigator# 108655
Lenexa, Kansas, 66219, United States
Site Reference ID/Investigator# 107115
Raleigh, North Carolina, 27612, United States
Site Reference ID/Investigator# 118964
Duncansville, Pennsylvania, 16635, United States
Site Reference ID/Investigator# 100780
Dallas, Texas, 75231, United States
Related Publications (2)
Khatri A, Goss S, Jiang P, Mansikka H, Othman AA. Pharmacokinetics of ABT-122, a TNF-alpha- and IL-17A-Targeted Dual-Variable Domain Immunoglobulin, in Healthy Subjects and Patients with Rheumatoid Arthritis: Results from Three Phase I Trials. Clin Pharmacokinet. 2018 May;57(5):613-623. doi: 10.1007/s40262-017-0580-y.
PMID: 28744796RESULTFleischmann RM, Wagner F, Kivitz AJ, Mansikka HT, Khan N, Othman AA, Khatri A, Hong F, Jiang P, Ruzek M, Padley RJ. Safety, Tolerability, and Pharmacodynamics of ABT-122, a Tumor Necrosis Factor- and Interleukin-17-Targeted Dual Variable Domain Immunoglobulin, in Patients With Rheumatoid Arthritis. Arthritis Rheumatol. 2017 Dec;69(12):2283-2291. doi: 10.1002/art.40319. Epub 2017 Nov 8.
PMID: 28941216DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert Padley, MD
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2013
First Posted
May 14, 2013
Study Start
July 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
November 20, 2017
Record last verified: 2014-06