ostheoarthritis pain
Conditions
Interventions
At baseline, subjects are randomized to 1 of 6 arms. All subjects receive
subcutaneous injections (1 ml in total) in the abdominal area on Day 1 and week
8 visit. Depending on the arm in which the s
Sponsors
AbbVie B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • you are between 18 and 70 years of age, inclusive; • Osteoarthritis in the index knee adapted from the American College of Rheumatology Clinical and Radiographic Criteria for Ostheoarthritis of the knee: History of pain in the index knee >= 6 months; AND Kellgren and Lawrence (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 = 40 mm with an increase of >= 10 mm from Screening Visit, o For subjects whose Screening VAS is >= 85 mm, a VAS of >= 85 mm must be maintained at the Baseline Visit; AND 2. Subject's Global Assessment of Arthritis Status must be Fair, Poor or Very Poor. • you require therapeutic doses of at least 1 of the following oral analgesics for OA pain during the previous 3 months, with a stable dose for at least 4 days per week during 4 weeks prior to Screening: * NSAIDs * COX-2 inhibitors * Tramadol or tapentadol * Opioids (alone or in combination products)
Exclusion criteria
Exclusion criteria: • Is scheduled for or is considering joint replacement surgery at any time during the study (including the Follow-up Period and the Post-Study Follow-up Period). • Has had any of the following: Joint replacement/reconstruction either knee at any time; OR Any major surgery, e.g., open surgery, to the index joint within the 12 months prior to the Screening Visit; OR Arthroscopic surgery to the index joint within 3 months prior to the Screening Visit; OR Trauma to the index knee within 12 months prior to the screening visit. • Has a history of osteonecrosis (ON) or rapidly progressive osteoarthritis (RPOA) in any joint. • Has OA of the index knee that meets K-L classification criteria of grade 0, 1 or 4. Subject has OA of the contralateral knee that meets the K-L classification of grade 4. • Has radiographic evidence (K-L grade >= 2 based on central radiologist interpretation of screening radiographs) of OA of the hip or shoulder joints. • Prior to the Screening Visit, has received: Oral corticosteroid therapy for a duration of > 2 weeks continuously or a total exposure of > 2 weeks (e.g. > 1 week of treatment on 2 or more separate occasions) within the previous 2 years; OR Intramuscular, intravenous or epidural corticosteroid therapy within the previous year; OR intra-articular injection of corticosteroids within the previous year; OR intra-articular injection of Synvisc (hyaluronic acid) in the index knee within the previous year. • Has a history of clinically significant sensitivity or allergy to: paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs); and/or has a history of injection site reaction or formation of anti-drug antibodies to a biologic compound. • Has a diagnosis of any of the following painful syndromes/conditions: - Inflammatory arthritides, such as rheumatoid arthritis (including juvenile rheumatoid arthritis), seronegative spondyloarthropathy or pseudogout; - History of infectious arthritis involving the index joint; - Clinically active gout within 3 months prior to the Screening Visit; - Paget's disease; - Fibromyalgia; - Neuropathic pain; or - Any other chronic painful syndrome(s)/condition(s) that could interfere with the assessment of pain in the index joint.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Efficacy assessments will include the following: Subjects Assessment of Arthritis Pain Intensity by VAS (100 mm), Western Ontario and McMasters Osteoarthritis Index (WOMAC*), EuroQol-5D* (EQ-5D-5L), Work Productivity and Activity Impairment (WPAI) Questionnaire, Subject's Global Assessment of Arthritis Status, and Subject's Global Assessment of Study Drug. Safety: Safety will be monitored throughout the study based on assessments of adverse events (AEs), physical examinations, neurological exams, vital signs, radiographic exams and laboratory values. Additionally, an Independent Data Monitoring Committee (IDMC) will monitor the safety data in an unblinded fashion, with a particular focus on AEs of special interest (AESI). | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic: Serum samples for ABT-110 PK and ADA testing will be obtained during the study. Values for the pharmacokinetic parameters of ABT-110 including apparent clearance (CL/F) and apparent volume of distribution (V/F) will be estimated using population pharmacokinetic modeling procedures. | — |
Countries
Netherlands
Outcome results
None listed