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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

NCT ID: NCT01668511

Last Updated: 2017-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Osteoarthritis

Keywords

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Immunogenicity Safety Tolerability Osteoarthritis Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group 1

Randomized 7 drug/2 placebo by group

Group Type EXPERIMENTAL

ABT-981

Intervention Type BIOLOGICAL

Injection

Placebo

Intervention Type BIOLOGICAL

Placebo Injection

Group 2

Randomized 7 drug/2 placebo by group

Group Type EXPERIMENTAL

ABT-981

Intervention Type BIOLOGICAL

Injection

Placebo

Intervention Type BIOLOGICAL

Placebo Injection

Group 3

Randomized 7 drug/2 placebo by group

Group Type EXPERIMENTAL

ABT-981

Intervention Type BIOLOGICAL

Injection

Placebo

Intervention Type BIOLOGICAL

Placebo Injection

Group 4

Randomized 7 drug/2 placebo by group

Group Type EXPERIMENTAL

ABT-981

Intervention Type BIOLOGICAL

Injection

Placebo

Intervention Type BIOLOGICAL

Placebo Injection

Interventions

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ABT-981

Injection

Intervention Type BIOLOGICAL

Placebo

Placebo Injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susanne X. Wang, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

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Site Reference ID/Investigator# 78613

Miami, Florida, United States

Site Status

Countries

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United States

References

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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-1alpha/beta dual variable domain immunoglobulin in patients with osteoarthritis of the knee: a randomized phase 1 study. Osteoarthritis Cartilage. 2017 Dec;25(12):1952-1961. doi: 10.1016/j.joca.2017.09.007. Epub 2017 Sep 28.

Reference Type RESULT
PMID: 28964890 (View on PubMed)

Other Identifiers

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M12-756

Identifier Type: -

Identifier Source: org_study_id