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

November 16, 2017 updated by: AbbVie

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Site Reference ID/Investigator# 108655
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Site Reference ID/Investigator# 107115
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Site Reference ID/Investigator# 118964
    • Texas
      • Dallas, Texas, United States, 75231
        • Site Reference ID/Investigator# 100780

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Adverse Events
Time Frame: 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
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
Time Frame: From date of first dose of ABT-122 until 42 days after last dose of ABT-122
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
Time Frame: From date of first dose of ABT-122 until 42 days after the last dose of ABT-122
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
Time Frame: 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
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
Time Frame: Prior to first dose up to 42 days after the last dose of ABT-122
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
Time Frame: Prior to each dose and up until 42 days after the last dose of ABT-122
Measurement of ADA
Prior to each dose and up until 42 days after the last dose of ABT-122

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: Robert Padley, MD, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

May 10, 2013

First Submitted That Met QC Criteria

May 10, 2013

First Posted (Estimate)

May 14, 2013

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 16, 2017

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M14-048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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