A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-122 in Subjects With Rheumatoid Arthritis

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety, tolerability and pharmacokinetics of ABT-122 in subjects with Rheumatoid Arthritis.

Detailed Description
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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.

Official Title
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A Study in Patients With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ABT-122

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Biological: ABT-122
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Randomized 6 drug/2 placebo by group | Biological: ABT-122<br>* Injection<br>Biological: Placebo<br>* Placebo Injection<br>|
| Experimental: Group 2<br>Randomized 6 drug/2 placebo by group | Biological: ABT-122<br>* Injection<br>Biological: Placebo<br>* Placebo Injection<br>|
| Experimental: Group 3<br>Randomized 6 drug/2 placebo by group | Biological: ABT-122<br>* Injection<br>Biological: Placebo<br>* Placebo Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of anti-drug anti-bodies (ADA) of ABT-122 | Measurement of ADA | Prior to each dose and up until 42 days after the last dose of ABT-122 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tolerability, Immunogenicity, Safety, Rheumatoid Arthritis, Pharmacokinetics