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

Completed · Phase 1 · Has a placebo group

Conditions studied: Osteoarthritis

In brief

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

Key facts

Study ID: NCT01668511
Run by: AbbVie (prior sponsor, Abbott)
People needed: 36
Starts: 2012-09-01
Expected to finish: 2013-10-01
Last updated by the study team: 2017-11-20

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Site Reference ID/Investigator# 78613 — Miami, Florida, United States

Full record on ClinicalTrials.gov

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