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
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, see Learn About Clinical Studies.

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 August 26, 2014