A Study Comparing the Safety and Analgesic Efficacy of ABT-110 inSubjects with Pain from Osteoarthritis of the Knee

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 390

Inclusion Criteria

1. Subject is between 18 and 70 years of age, inclusive.
2. Osteoarthritis pain in the index knee which meets the following:
? History of pain in the index knee = 6 months; AND
? K-L Grade 2 or 3 only on plain radiographs of the index knee; AND
? At least 1 of the following 3 criteria:
? Age > 50 years; OR
? Stiffness < 30 minutes upon awakening; OR
? Crepitus in the index knee.
3. Subject must meet the following pain criteria at the time of the Baseline Visit:
? Subject's Assessment of Arthritis Pain Intensity (VAS) of the index knee is = 40 mm with an increase of = 10 mm from the Screening Visit,
o For subjects whose Screening VAS is = 85 mm, a VAS of = 85 mm must be maintained at the Baseline Visit; AND
? Subject's Global Assessment of Arthritis Status must be Fair, Poor or Very Poor.
4. Subject requires therapeutic doses of at least 1 non-opioid analgesic for OA pain for at least 4 days per week during the 4 weeks prior to the Screening Visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 310
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

1. Subject is scheduled for or is considering joint replacement surgery within 6 months following the Screening Visit.
2. Subject has had any of the following:
? Joint replacement/reconstruction to the index joint at any time;
? Any major surgery, e.g., open surgery, to the index joint within 12 months
prior to the Screening Visit; OR
? Arthroscopic surgery to the index joint within 3 months prior to the Screening
Visit.
3. Subject has a history of osteonecrosis in any joint.
4. Subject has OA of the knee that meets the K-L classification criteria of grade 0, 1
or 4.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to compare the safety, tolerability and analgesic efficacy of ABT-110 administered SC once every 8 weeks (q8w) for a total of 3 doses to placebo in subjects with pain due to OA of the knee.;Secondary Objective: A secondary objective of this study is to explore the population pharmacokinetics of ABT-110.;Primary end point(s): Change from baseline to subject's final evaluation on pain intensity as<br>measured by a 100 mm Visual Analog Scale (VAS);Timepoint(s) of evaluation of this end point: 0, 8, 16 and 24 weeks

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 0, 8, 16 and 24 weeks;Secondary end point(s): Western Ontario and McMasters Osteoarthritis Index (WOMAC™),<br>EuroQol-5D™ (EQ-5D-5L), Work Productivity and Activity Impairment (WPAI) Questionnaire

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