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

A Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled Study Comparing the Safety and Analgesic Efficacy of ABT-110 to Placebo in Subjects with Pain from Osteoarthritis of the Knee

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002144-27-NL

Enrollment

390

Registered

2011-10-19

Start date

2012-07-02

Completion date

Unknown

Last updated

2013-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain from Osteoarthritis of the Knee MedDRA version: 14.0 Level: LLT Classification code 10031165 Term: Osteoarthritis knee System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Code: ABT-110 Pharmaceutical Form: Lyophilisate for solution for injection Current Sponsor code: ABT-110 Other descriptive name: Humanized anti-Nerve Growth Factor IgG4 kappa monoclonal antibo

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 80

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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 measured by a 100 mm Visual Analog Scale (VAS);Timepoint(s) of evaluation of this end point: 0, 8, 16 and 24 weeks	—

Measure

Time frame

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 measured by a 100 mm Visual Analog Scale (VAS);Timepoint(s) of evaluation of this end point: 0, 8, 16 and 24 weeks

—

Secondary

Measure	Time frame
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™), EuroQol-5D™ (EQ-5D-5L), Work Productivity and Activity Impairment (WPAI) Questionnaire	—

Countries

Argentina, Australia, Finland, Germany, Italy, Netherlands, Poland, Singapore, South Africa, Sweden

Contacts

Public ContactEU Clinical Trials Helpdesk

Abbott Laboratories

euclinicaltrials@abbott.com+441628644475

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026