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A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-981 in Patients With Osteoarthritis of the Knee

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01668511
First Posted: August 20, 2012
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 ( AbbVie (prior sponsor, Abbott) )
  Purpose
To assess the safety, tolerability and pharmacokinetics of ABT-981 in patients with osteoarthritis of the knee.

Condition Intervention Phase
Osteoarthritis Biological: ABT-981 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 Randomized, Double-Blind, Placebo Controlled Study in Patients With Osteoarthritis of the Knee to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of ABT-981

Resource links provided by NLM:


Further study details as provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

Primary Outcome Measures:
  • Number of participants with Adverse Events [ Time Frame: From date of first dose of ABT-981 until 70 days after the last dose of ABT-981 ]
    Collect all adverse events at each visit

  • Physical Exam including vital signs [ Time Frame: From date of first dose of ABT-981 until 70 days after last dose of ABT-981 ]
    Blood pressure, heart rate and body temperature

  • Clinical Lab Testing [ Time Frame: From date of first dose of ABT-981 until 70 days after the last dose of ABT-981 ]
    Hematology, Chemistry, and Urinalysis

  • Change from Baseline in Electrocardiogram (ECG) [ Time Frame: Prior to dose and 8 hours post dose on each day of dosing ]
    ECGs done in triplicate

  • Maximum observed serum concentration (Cmax) of ABT-981 [ Time Frame: Prior to first dose up to 70 days after the last dose of ABT-981 ]
    Cmax

  • Time to Cmax (Tmax) of ABT-981 [ Time Frame: Prior to first dose up to 70 days after the last dose of ABT-981 ]
    Time to Cmax

  • The area under the time curve (AUC) of ABT-981 [ Time Frame: Prior to first dose up until 70 days after the last dose of ABT-981 ]
    AUC

  • The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-981 [ Time Frame: Prior to the last dose up to 70 days after the last dose of ABT-981 ]
    The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-981


Secondary Outcome Measures:
  • Measurement of anti-drug anti-bodies (ADA) of ABT-981 [ Time Frame: Prior to each dose and up until 70 days after the last dose of ABT-981 ]
    Measurement of ADA


Enrollment: 36
Study Start Date: September 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Randomized 7 drug/2 placebo by group
Biological: ABT-981
Injection
Biological: Placebo
Placebo Injection
Experimental: Group 2
Randomized 7 drug/2 placebo by group
Biological: ABT-981
Injection
Biological: Placebo
Placebo Injection
Experimental: Group 3
Randomized 7 drug/2 placebo by group
Biological: ABT-981
Injection
Biological: Placebo
Placebo Injection
Experimental: Group 4
Randomized 7 drug/2 placebo by group
Biological: ABT-981
Injection
Biological: Placebo
Placebo Injection

Detailed Description:
This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study. Thirty-six patients with osteoarthritis of the knee will be selected to participate. Patients will be randomized to receive either ABT-981 or placebo. ABT-981 or placebo will be administered as subcutaneous (under the skin) injections in four dosing groups. Subjects will be administered subcutaneous injections of ABT-981 for up to 8 weeks.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male or female, 40 to 70 years of age, inclusive.
  • History of symptomatic osteoarthritis (OA) of the knee joint for at least 3 months, with typical Osteoarthritis (OA) symptoms
  • Radiographic Osteoarthritis (OA) of Kellgren-Lawrence (K-L) grade 1, 2 or 3
  • Patients assessment of Osteoarthritis (OA) pain intensity of the study joint is between 40 and 80 on the 0 - 100 mm VAS scale
  • Other than Osteoarthritis (OA) of the study joint, patient should be in general good health

Exclusion Criteria:

  • Radiographic OA of Kellgren-Lawrence grade 4 or chronic opioid user due to severe knee OA
  • History of allergic reaction or significant sensitivity to any constituents of the study drug and acetominophen or history of anaphylactic reaction to any agent
  • Significant trauma or surgery to the study joint within the last year or arthroscopy within 6 months, or, scheduled for major surgery to the study joint
  • Diagnosis of rheumatoid arthritis, other autoimmune disorders or any arthritis other than Osteoarthritis (OA) of the knee.
  • Any uncontrolled medical illness including unstable treatment or therapy.
  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): NCT01668511


Locations
United States, Florida
Site Reference ID/Investigator# 78613
Miami, Florida, United States, 33136
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Susanne X. Wang, MD AbbVie
  More Information

Publications:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01668511     History of Changes
Other Study ID Numbers: M12-756
First Submitted: August 1, 2012
First Posted: August 20, 2012
Last Update Posted: November 20, 2017
Last Verified: November 2013

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Immunogenicity
Safety
Tolerability
Osteoarthritis
Pharmacokinetics

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases