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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01853033
First Posted: May 14, 2013
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie
  Purpose
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of ABT-122 in subjects with Rheumatoid Arthritis.

Condition Intervention Phase
Rheumatoid Arthritis Biological: ABT-122 Biological: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Study in Patients With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ABT-122

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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

  • 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

  • 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

  • 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

  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 19
Study Start Date: July 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Randomized 6 drug/2 placebo by group
Biological: ABT-122
Injection
Biological: Placebo
Placebo Injection
Experimental: Group 2
Randomized 6 drug/2 placebo by group
Biological: ABT-122
Injection
Biological: Placebo
Placebo Injection
Experimental: Group 3
Randomized 6 drug/2 placebo by group
Biological: ABT-122
Injection
Biological: Placebo
Placebo Injection

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853033


Locations
United States, Kansas
Site Reference ID/Investigator# 108655
Lenexa, Kansas, United States, 66219
United States, North Carolina
Site Reference ID/Investigator# 107115
Raleigh, North Carolina, United States, 27612
United States, Pennsylvania
Site Reference ID/Investigator# 118964
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Site Reference ID/Investigator# 100780
Dallas, Texas, United States, 75231
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Robert Padley, MD AbbVie
  More Information

Publications:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01853033     History of Changes
Other Study ID Numbers: M14-048
First Submitted: May 10, 2013
First Posted: May 14, 2013
Last Update Posted: November 20, 2017
Last Verified: June 2014

Keywords provided by AbbVie:
Tolerability
Immunogenicity
Safety
Rheumatoid Arthritis
Pharmacokinetics

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases