Completed

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

What is being tested

ABT-981

+ Placebo

+ ABT-981

Biological

Who is being recruted

Arthritis+2

+ Joint Diseases

+ Musculoskeletal Diseases

From 40 to 70 Years

+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: September 2012

See protocol details

Summary

Principal SponsorAbbVie (prior sponsor, Abbott)

Last updated: November 20, 2017

Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01668511

Principal SponsorAbbVie (prior sponsor, Abbott)

Last updated: November 20, 2017

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

36 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesOsteoarthritis

Criteria

5 inclusion criteria required to participate

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

Other than Osteoarthritis (OA) of the study joint, patient should be in general good health

Patients assessment of Osteoarthritis (OA) pain intensity of the study joint is between 40 and 80 on the 0 - 100 mm VAS scale

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5 exclusion criteria prevent from participating

Any uncontrolled medical illness including unstable treatment or therapy

Diagnosis of rheumatoid arthritis, other autoimmune disorders or any arthritis other than Osteoarthritis (OA) of the knee

History of allergic reaction or significant sensitivity to any constituents of the study drug and acetominophen or history of anaphylactic reaction to any agent

Radiographic OA of Kellgren-Lawrence grade 4 or chronic opioid user due to severe knee OA

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Randomized 7 drug/2 placebo by group

Group II

Experimental

Randomized 7 drug/2 placebo by group

Group III

Experimental

Randomized 7 drug/2 placebo by group

Group IV

Experimental

Randomized 7 drug/2 placebo by group

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Site Reference ID/Investigator# 78613

Miami, United StatesOpen Site Reference ID/Investigator# 78613 in Google Maps

CompletedOne Study Center