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:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01668511
First received: August 1, 2012
Last updated: November 4, 2013
Last verified: November 2013
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01668511     History of Changes
Other Study ID Numbers: M12-756
Study First Received: August 1, 2012
Last Updated: November 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
Immunogenicity
Safety
Tolerability
Osteoarthritis
Pharmacokinetics

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

ClinicalTrials.gov processed this record on April 20, 2014