A Phase 2a Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients with Knee Osteoarthritis

Phase 1

Conditions: Adult male and female patients with mild to moderate, symptomatic, radiographic and inflammatory osteoarthritis of the knee
MedDRA version: 17.0Level: PTClassification code 10031161Term: OsteoarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2013-003467-60-ES

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 320

Inclusion Criteria

1.Patient must have radiographic evidence of knee osteoarthritis in the medial compartment of the index knee with Kellgren-Lawrence Grade 2 or 3 (with minimum 2 mm joint space width) during Screening as evaluated by a qualified central imaging reader. Prior radiographs taken no more than 3 months before Study Day 1 with Synaflexer? will be submitted for centralized eligibility reading.
2. Patient must have either constant or intermittent index knee pain at least 14 days over the past 30 days at screening. The intensity of index knee pain is between 4 and 8 out of 10, inclusive, at the initial Screening Visit and Study Day 1. The intensity of index knee pain is recorded as the average pain during the past week.
3.Patient has one or more clinical signs and symptoms of active inflammation in the index knee (localized pain, joint stiffness, swelling and effusion) during Screening and Study Day 1.
4.Presence of synovitis in the index knee confirmed by ultrasound during Screening.
5.Patient discontinued analgesics, non-steroidal anti-inflammatory drugs and nutraceuticals (e.g., glucosamine, chondroitin sulfate, shark cartilage, diacerein, soy extract) at least 7 days prior to first dose of study drug until after Week 26 MRI 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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

1.History of allergic reaction or significant sensitivity to any constituents of the study drug, history of anaphylactic reaction to any agent (e.g., food products or bee stings) or history of a major reaction to any IgG-containing product.
2.Significant trauma or surgery to the index knee within the last year or arthroscopy of the index knee within 6 months of Screening.
3.Kellgren-Lawrence Grade 1 or 4 in the index knee.
4.Severe knee malalignment, either greater than 2° in varus; or greater than 5° in valgus angulation in the index knee.
5.Diagnosis of one or more of the following:
a.Inflammatory arthritis such as rheumatoid arthritis, autoimmune disorder, seronegative spondyloarthropathy, gout, or pseudogout (defined as acute episodic attacks of swollen , painful joints in a patient with X-Ray chondrocalcinosis or CPPD crystals);
b.Other chronic painful syndromes (such as Paget's disease and fibromyalgia) and clinically significant non-articular musculoskeletal pain that could interfere with assessment of pain at the index knee.
6. History or evidence of active tuberculosis (TB)
7. Any uncontrolled medical illness or unstable treatment ot therapy.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect of ABT-981 on OA knee pain using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 16 and synovitis/effusion volume of the index knee using quantitative measures and semi-quantitative MRI scoring at Week 26 in patients with knee osteoarthritis.;Secondary Objective: n/a;Primary end point(s): The change from baseline to week 16 in OA knee pain using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and from baseline to week 26 in synovitis/effusion volume of the index knee using quantitative and semi-quantitative MRI scoring;Timepoint(s) of evaluation of this end point: Week 16 and Week 26

Secondary Outcome Measures

Name	Time	Method

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