Back to resultsA Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-122 in Subjects With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ABT-122
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Tolerability, Immunogenicity, Safety, Rheumatoid Arthritis, Pharmacokinetics
Eligibility Criteria
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.
Sites / Locations
- Site Reference ID/Investigator# 108655
- Site Reference ID/Investigator# 107115
- Site Reference ID/Investigator# 118964
- Site Reference ID/Investigator# 100780
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Arm Description
Randomized 6 drug/2 placebo by group
Randomized 6 drug/2 placebo by group
Randomized 6 drug/2 placebo by group
Outcomes
Primary Outcome Measures
Number of participants with Adverse Events
Collect all adverse events at each visit
Change in physical exam including vital signs
Blood pressure, pulse and body temperature
Change in clinical lab test results
Hematology, Chemistry, and Urinalysis
Change in Electrocardiogram (ECG) results
ECGs done in triplicate
Determination of pharmacokinetic (PK) parameters
Cmax, Tmax, AUC, elimination rate constant and half-life
Secondary Outcome Measures
Measurement of anti-drug anti-bodies (ADA) of ABT-122
Measurement of ADA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01853033
Brief Title
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-122 in Subjects With Rheumatoid Arthritis
Official Title
A Study in Patients With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ABT-122
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Tolerability, Immunogenicity, Safety, Rheumatoid Arthritis, Pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Randomized 6 drug/2 placebo by group
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Randomized 6 drug/2 placebo by group
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Randomized 6 drug/2 placebo by group
Intervention Type
Biological
Intervention Name(s)
ABT-122
Intervention Description
Injection
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo Injection
Primary Outcome Measure Information:
Title
Number of participants with Adverse Events
Description
Collect all adverse events at each visit
Time Frame
From date of first dose of ABT-122 until 42 days after the last dose of ABT-122
Title
Change in physical exam including vital signs
Description
Blood pressure, pulse and body temperature
Time Frame
From date of first dose of ABT-122 until 42 days after last dose of ABT-122
Title
Change in clinical lab test results
Description
Hematology, Chemistry, and Urinalysis
Time Frame
From date of first dose of ABT-122 until 42 days after the last dose of ABT-122
Title
Change in Electrocardiogram (ECG) results
Description
ECGs done in triplicate
Time Frame
From subject's baseline (prior to subject's first dose) and up to 168 hours following the last dose of study drug
Title
Determination of pharmacokinetic (PK) parameters
Description
Cmax, Tmax, AUC, elimination rate constant and half-life
Time Frame
Prior to first dose up to 42 days after the last dose of ABT-122
Secondary Outcome Measure Information:
Title
Measurement of anti-drug anti-bodies (ADA) of ABT-122
Description
Measurement of ADA
Time Frame
Prior to each dose and up until 42 days after the last dose of ABT-122
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Padley, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 108655
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Site Reference ID/Investigator# 107115
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Site Reference ID/Investigator# 118964
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Site Reference ID/Investigator# 100780
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28744796
Citation
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.
Results Reference
result
PubMed Identifier
28941216
Citation
Fleischmann 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.
Results Reference
derived
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A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-122 in Subjects With Rheumatoid Arthritis
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