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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01668511
• Other study ID #: M12-756
• Status: Completed
• Phase: Phase 1
• First received: August 1, 2012
• Last updated: November 16, 2017
• Start date: September 2012
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the safety, tolerability and pharmacokinetics of ABT-981 in patients with osteoarthritis of the knee.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• ABT-981
Injection
• Placebo
Placebo Injection

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 78613	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Wang SX, Abramson SB, Attur M, Karsdal MA, Preston RA, Lozada CJ, Kosloski MP, Hong F, Jiang P, Saltarelli MJ, Hendrickson BA, Medema JK. Safety, tolerability, and pharmacodynamics of an anti-interleukin-1a/ß dual variable domain immunoglobulin in patient — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse Events	Collect all adverse events at each visit	From date of first dose of ABT-981 until 70 days after the last dose of ABT-981
Primary	Physical Exam including vital signs	Blood pressure, heart rate and body temperature	From date of first dose of ABT-981 until 70 days after last dose of ABT-981
Primary	Clinical Lab Testing	Hematology, Chemistry, and Urinalysis	From date of first dose of ABT-981 until 70 days after the last dose of ABT-981
Primary	Change from Baseline in Electrocardiogram (ECG)	ECGs done in triplicate	Prior to dose and 8 hours post dose on each day of dosing
Primary	Maximum observed serum concentration (Cmax) of ABT-981	Cmax	Prior to first dose up to 70 days after the last dose of ABT-981
Primary	Time to Cmax (Tmax) of ABT-981	Time to Cmax	Prior to first dose up to 70 days after the last dose of ABT-981
Primary	The area under the time curve (AUC) of ABT-981	AUC	Prior to first dose up until 70 days after the last dose of ABT-981
Primary	The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-981	The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-981	Prior to the last dose up to 70 days after the last dose of ABT-981
Secondary	Measurement of anti-drug anti-bodies (ADA) of ABT-981	Measurement of ADA	Prior to each dose and up until 70 days after the last dose of ABT-981