A Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis, Medial Compartment Knee Osteoarthritis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ABT-981
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Osteoarthritis, Synovitis, Knee, Pain
Eligibility Criteria
Inclusion Criteria:
- Radiographic knee osteoarthritis with Kellgren-Lawrence Grade 2 or 3
- Body Mass Index (BMI) 18-34 kg/m2
- One or more clinical signs and symptoms of active inflammation in the index knee
Exclusion Criteria:
- History of allergic reaction to any constituents of the study drug, or to any Immunoglobulin G (IgG)-containing product
- History of anaphylactic reaction to any agent
- Significant trauma or surgery to the index knee
- Severe knee malalignment
- Any uncontrolled medical illness or an unstable treatment or therapy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
ABT-981 low dose
ABT-981 medium dose
ABT-981 high dose
Placebo
Arm Description
25 mg ABT-981 subcutaneous (SC) every 2 weeks (E2W)
100 mg ABT-981 SC E2W
200 mg ABT-981 SC E2W
Placebo
Outcomes
Primary Outcome Measures
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16
The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) numerical rating scale (NRS). The pain sub-score has a range of 0 (no pain) to 50 (maximum pain). A negative change from baseline indicates improvement.
Change From Baseline in Quantitative Synovitis of the Index Knee at Week 26
Change in synovitis of the index knee was evaluated using quantitative magnetic resonance imaging (MRI) measurements. MRI quantitative synovitis of the index knee was defined by mean synovial membrane thickness.
Change From Baseline in Effusion Volume of the Index Knee at Week 26
Change From Baseline in Whole-Organ Magnetic Resonance Imaging Score (WORMS) Semi-Quantitative Synovitis/Effusion Score of the Index Knee at Week 26
Semi-quantitative synovitis/effusion volume WORMS scores were scored as normal (0), < 33% of maximum estimated distention (1), 33% - 66% of maximum estimated distention (2), or > 66% of maximum estimated distention (3).
Secondary Outcome Measures
Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 16
The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) NRS. The WOMAC physical function subscale score was 0 (normal) to 170 (least physical function). A negative change from baseline indicates improvement.
Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 26
The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) NRS. The WOMAC physical function subscale score was 0 (normal) to 170 (least physical function). A negative change from baseline indicates improvement.
Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 52
The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) NRS. The WOMAC physical function subscale score was 0 (normal) to 170 (least physical function). A negative change from baseline indicates improvement.
Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 26
The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) numerical rating scale (NRS). The pain sub-score has a range of 0 (no pain) to 50 (maximum pain). A negative change from baseline indicates improvement.
Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 52
The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) numerical rating scale (NRS). The pain sub-score has a range of 0 (no pain) to 50 (maximum pain). A negative change from baseline indicates improvement.
Change From Baseline in Global Total Bone Marrow Lesion (BML) Score of the Index Knee Magnetic Resonance Imaging (MRI) at Week 26
BMLs in 15 regions were measured with MRI, and graded as 0 (normal), 1 (mild; < 25% of region), 2 (moderate; 25% - 50% of region), or 3 (severe; > 50% of region). The global total BML score was the sum of the 15 component scores, and ranged from 0 (normal) to 45 (severe).
Change From Baseline in Global Total BML Score of the Index Knee MRI at Week 52
BMLs in 15 regions were measured with MRI, and graded as 0 (normal), 1 (mild; < 25% of region), 2 (moderate; 25% - 50% of region), or 3 (severe; > 50% of region). The global total BML score was the sum of the 15 component scores, and ranged from 0 (normal) to 45 (severe).
Change From Baseline in Index Knee Intermittent and Constant Osteoarthritis Pain (ICOAP) Scores at Week 16
The ICOAP is a multidimensional osteoarthritis-specific measure designed to comprehensively evaluate the pain experience in patients with hip or knee osteoarthritis. The ICOAP includes 11 items (5 constant pain items; 6 intermittent pain items). Each item is rated on a 0 to 4 point scale with a 7-day recall period. The raw maximum intermittent pain score ranges from 0 to 24, transformed to a reported scale of 0 (no pain) to 100 (worst pain). The raw maximum constant pain score ranges from 0 to 20, transformed to a reported scale of 0 (no pain) to 100 (worst pain).
Change From Baseline in Index Knee ICOAP Scores at Week 26
The ICOAP is a multidimensional osteoarthritis-specific measure designed to comprehensively evaluate the pain experience in patients with hip or knee osteoarthritis. The ICOAP includes 11 items (5 constant pain items; 6 intermittent pain items). Each item is rated on a 0 to 4 point scale with a 7-day recall period. The raw maximum intermittent pain score ranges from 0 to 24, transformed to a reported scale of 0 (no pain) to 100 (worst pain). The raw maximum constant pain score ranges from 0 to 20, transformed to a reported scale of 0 (no pain) to 100 (worst pain).
Change From Baseline in Index Knee ICOAP Scores at Week 52
The ICOAP is a multidimensional osteoarthritis-specific measure designed to comprehensively evaluate the pain experience in patients with hip or knee osteoarthritis. The ICOAP includes 11 items (5 constant pain items; 6 intermittent pain items). Each item is rated on a 0 to 4 point scale with a 7-day recall period. The raw maximum intermittent pain score ranges from 0 to 24, transformed to a reported scale of 0 (no pain) to 100 (worst pain). The raw maximum constant pain score ranges from 0 to 20, transformed to a reported scale of 0 (no pain) to 100 (worst pain).
Change From Baseline In Index Knee Pain Intensity at Week 16
The index knee pain intensity was assessed in 3 different ways using an 11 -point NRS (0 to 10 points representing 'no pain' to 'worst possible pain'). Subjects were asked to enter: 1) average pain intensity during the past week (7-day recall period); 2) the worst pain during activity over the past 24 hours; 3) pain intensity before and after a 40 meter walk (performance pain, before and after). The 40 meter fast paced walk test is a test of short distance walking activity, walking speed over short distances and changing direction during walking. Individuals taking the test should walk as quickly but as safely as possible, without running, along a walkway and then turn around, and repeat again for a total distance of 40 m (132 feet). The total time taken to walk the 40 meters is recorded.
Change From Baseline In Index Knee Pain Intensity at Week 26
The index knee pain intensity was assessed in 3 different ways using an 11 -point NRS (0 to 10 points representing 'no pain' to 'worst possible pain'). Subjects were asked to enter: 1) average pain intensity during the past week (7-day recall period); 2) the worst pain during activity over the past 24 hours; 3) pain intensity before and after a 40 meter walk (performance pain, before and after). The 40 meter fast paced walk test is a test of short distance walking activity, walking speed over short distances and changing direction during walking. Individuals taking the test should walk as quickly but as safely as possible, without running, along a walkway and then turn around, and repeat again for a total distance of 40 m (132 feet). The total time taken to walk the 40 meters is recorded.
Change From Baseline In Index Knee Pain Intensity at Week 52
The index knee pain intensity was assessed in 3 different ways using an 11 -point NRS (0 to 10 points representing 'no pain' to 'worst possible pain'). Subjects were asked to enter: 1) average pain intensity during the past week (7-day recall period); 2) the worst pain during activity over the past 24 hours; 3) pain intensity before and after a 40 meter walk (performance pain, before and after). The 40 meter fast paced walk test is a test of short distance walking activity, walking speed over short distances and changing direction during walking. Individuals taking the test should walk as quickly but as safely as possible, without running, along a walkway and then turn around, and repeat again for a total distance of 40 m (132 feet). The total time taken to walk the 40 meters is recorded.
Change From Baseline in Patient Global Assessment (PGA) of Arthritis of the Index Knee at Week 16
The PGA is a single item for evaluating overall osteoarthritis disease activity. PGA is assessed using an 11-point NRS of 0 to 10 points (representing best to worst disease status, respectively), with a 7-day recall period.
Change From Baseline in PGA of Arthritis of the Index Knee at Week 26
The PGA is a single item for evaluating overall osteoarthritis disease activity. PGA is assessed using an 11-point NRS of 0 to 10 points (representing best to worst disease status, respectively), with a 7-day recall period.
Change From Baseline in PGA of Arthritis of the Index Knee at Week 52
The PGA is a single item for evaluating overall osteoarthritis disease activity. PGA is assessed using an 11-point NRS of 0 to 10 points (representing best to worst disease status, respectively), with a 7-day recall period.
Change From Baseline in Cartilage Volume of the Index Knee at Week 26
Cartilage volume of the global knee, the medial central condyle + plateau, and the medial condyle + plateau was measured using MRI.
Change From Baseline in Cartilage Volume of the Index Knee at Week 52
Cartilage volume of the global knee, the medial central condyle + plateau, and the medial condyle + plateau was measured using MRI.
Change From Baseline in Cartilage Thickness of the Index Knee at Week 26
Cartilage thickness of the global knee, the medial central condyle + plateau, and the medial condyle + plateau was measured using MRI.
Change From Baseline in Cartilage Thickness of the Index Knee at Week 52
Cartilage thickness of the global knee, the medial central condyle + plateau, and the medial condyle + plateau was measured using MRI.
Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 16
Percentage of participants classified as OMERACT-OARSI responders at Week 16. A subject was considered an OMERACT-OARSI responder if any of the following 3 criteria were met: 1. WOMAC Pain (in 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 2. WOMAC Function (in normalized 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 3. At least 2 of the following 3 are met: WOMAC Pain improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; WOMAC Function improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; PGA improvement ≥ 20% and absolute change (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline. Response rate 95% confidence interval based on normal approximation.
Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 26
Percentage of participants classified as OMERACT-OARSI responders at Week 26. A subject was considered an OMERACT-OARSI responder if any of the following 3 criteria were met: 1. WOMAC Pain (in 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 2. WOMAC Function (in normalized 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 3. At least 2 of the following 3 are met: WOMAC Pain improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; WOMAC Function improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; PGA improvement ≥ 20% and absolute change (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline. Response rate 95% confidence interval based on normal approximation.
Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 52
Percentage of participants classified as OMERACT-OARSI responders at Week 52. A subject was considered an OMERACT-OARSI responder if any of the following 3 criteria were met: 1. WOMAC Pain (in 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 2. WOMAC Function (in normalized 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 3. At least 2 of the following 3 are met: WOMAC Pain improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; WOMAC Function improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; PGA improvement ≥ 20% and absolute change (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline. Response rate 95% confidence interval based on normal approximation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02087904
Brief Title
A Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis
Official Title
A Phase 2a Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 4, 2014 (Actual)
Primary Completion Date
June 7, 2016 (Actual)
Study Completion Date
December 13, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Phase 2a, multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the safety, tolerability, efficacy and pharmacokinetic/pharmacodynamic effect of ABT-981 in patients with symptomatic, radiographic, and inflammatory knee osteoarthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Medial Compartment Knee Osteoarthritis
Keywords
Osteoarthritis, Synovitis, Knee, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
350 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABT-981 low dose
Arm Type
Experimental
Arm Description
25 mg ABT-981 subcutaneous (SC) every 2 weeks (E2W)
Arm Title
ABT-981 medium dose
Arm Type
Experimental
Arm Description
100 mg ABT-981 SC E2W
Arm Title
ABT-981 high dose
Arm Type
Experimental
Arm Description
200 mg ABT-981 SC E2W
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Biological
Intervention Name(s)
ABT-981
Other Intervention Name(s)
Lutikizumab
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16
Description
The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) numerical rating scale (NRS). The pain sub-score has a range of 0 (no pain) to 50 (maximum pain). A negative change from baseline indicates improvement.
Time Frame
Baseline, Week 16
Title
Change From Baseline in Quantitative Synovitis of the Index Knee at Week 26
Description
Change in synovitis of the index knee was evaluated using quantitative magnetic resonance imaging (MRI) measurements. MRI quantitative synovitis of the index knee was defined by mean synovial membrane thickness.
Time Frame
Baseline, Week 26
Title
Change From Baseline in Effusion Volume of the Index Knee at Week 26
Time Frame
Baseline, Week 26
Title
Change From Baseline in Whole-Organ Magnetic Resonance Imaging Score (WORMS) Semi-Quantitative Synovitis/Effusion Score of the Index Knee at Week 26
Description
Semi-quantitative synovitis/effusion volume WORMS scores were scored as normal (0), < 33% of maximum estimated distention (1), 33% - 66% of maximum estimated distention (2), or > 66% of maximum estimated distention (3).
Time Frame
Baseline, Week 26
Secondary Outcome Measure Information:
Title
Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 16
Description
The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) NRS. The WOMAC physical function subscale score was 0 (normal) to 170 (least physical function). A negative change from baseline indicates improvement.
Time Frame
Baseline, Week 16
Title
Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 26
Description
The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) NRS. The WOMAC physical function subscale score was 0 (normal) to 170 (least physical function). A negative change from baseline indicates improvement.
Time Frame
Baseline, Week 26
Title
Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 52
Description
The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) NRS. The WOMAC physical function subscale score was 0 (normal) to 170 (least physical function). A negative change from baseline indicates improvement.
Time Frame
Baseline, Week 52
Title
Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 26
Description
The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) numerical rating scale (NRS). The pain sub-score has a range of 0 (no pain) to 50 (maximum pain). A negative change from baseline indicates improvement.
Time Frame
Baseline, Week 26
Title
Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 52
Description
The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) numerical rating scale (NRS). The pain sub-score has a range of 0 (no pain) to 50 (maximum pain). A negative change from baseline indicates improvement.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Global Total Bone Marrow Lesion (BML) Score of the Index Knee Magnetic Resonance Imaging (MRI) at Week 26
Description
BMLs in 15 regions were measured with MRI, and graded as 0 (normal), 1 (mild; < 25% of region), 2 (moderate; 25% - 50% of region), or 3 (severe; > 50% of region). The global total BML score was the sum of the 15 component scores, and ranged from 0 (normal) to 45 (severe).
Time Frame
Baseline, Week 26
Title
Change From Baseline in Global Total BML Score of the Index Knee MRI at Week 52
Description
BMLs in 15 regions were measured with MRI, and graded as 0 (normal), 1 (mild; < 25% of region), 2 (moderate; 25% - 50% of region), or 3 (severe; > 50% of region). The global total BML score was the sum of the 15 component scores, and ranged from 0 (normal) to 45 (severe).
Time Frame
Baseline, Week 52
Title
Change From Baseline in Index Knee Intermittent and Constant Osteoarthritis Pain (ICOAP) Scores at Week 16
Description
The ICOAP is a multidimensional osteoarthritis-specific measure designed to comprehensively evaluate the pain experience in patients with hip or knee osteoarthritis. The ICOAP includes 11 items (5 constant pain items; 6 intermittent pain items). Each item is rated on a 0 to 4 point scale with a 7-day recall period. The raw maximum intermittent pain score ranges from 0 to 24, transformed to a reported scale of 0 (no pain) to 100 (worst pain). The raw maximum constant pain score ranges from 0 to 20, transformed to a reported scale of 0 (no pain) to 100 (worst pain).
Time Frame
Baseline, Week 16
Title
Change From Baseline in Index Knee ICOAP Scores at Week 26
Description
The ICOAP is a multidimensional osteoarthritis-specific measure designed to comprehensively evaluate the pain experience in patients with hip or knee osteoarthritis. The ICOAP includes 11 items (5 constant pain items; 6 intermittent pain items). Each item is rated on a 0 to 4 point scale with a 7-day recall period. The raw maximum intermittent pain score ranges from 0 to 24, transformed to a reported scale of 0 (no pain) to 100 (worst pain). The raw maximum constant pain score ranges from 0 to 20, transformed to a reported scale of 0 (no pain) to 100 (worst pain).
Time Frame
Baseline, Week 26
Title
Change From Baseline in Index Knee ICOAP Scores at Week 52
Description
The ICOAP is a multidimensional osteoarthritis-specific measure designed to comprehensively evaluate the pain experience in patients with hip or knee osteoarthritis. The ICOAP includes 11 items (5 constant pain items; 6 intermittent pain items). Each item is rated on a 0 to 4 point scale with a 7-day recall period. The raw maximum intermittent pain score ranges from 0 to 24, transformed to a reported scale of 0 (no pain) to 100 (worst pain). The raw maximum constant pain score ranges from 0 to 20, transformed to a reported scale of 0 (no pain) to 100 (worst pain).
Time Frame
Baseline, Week 52
Title
Change From Baseline In Index Knee Pain Intensity at Week 16
Description
The index knee pain intensity was assessed in 3 different ways using an 11 -point NRS (0 to 10 points representing 'no pain' to 'worst possible pain'). Subjects were asked to enter: 1) average pain intensity during the past week (7-day recall period); 2) the worst pain during activity over the past 24 hours; 3) pain intensity before and after a 40 meter walk (performance pain, before and after). The 40 meter fast paced walk test is a test of short distance walking activity, walking speed over short distances and changing direction during walking. Individuals taking the test should walk as quickly but as safely as possible, without running, along a walkway and then turn around, and repeat again for a total distance of 40 m (132 feet). The total time taken to walk the 40 meters is recorded.
Time Frame
Baseline, Week 16
Title
Change From Baseline In Index Knee Pain Intensity at Week 26
Description
The index knee pain intensity was assessed in 3 different ways using an 11 -point NRS (0 to 10 points representing 'no pain' to 'worst possible pain'). Subjects were asked to enter: 1) average pain intensity during the past week (7-day recall period); 2) the worst pain during activity over the past 24 hours; 3) pain intensity before and after a 40 meter walk (performance pain, before and after). The 40 meter fast paced walk test is a test of short distance walking activity, walking speed over short distances and changing direction during walking. Individuals taking the test should walk as quickly but as safely as possible, without running, along a walkway and then turn around, and repeat again for a total distance of 40 m (132 feet). The total time taken to walk the 40 meters is recorded.
Time Frame
Baseline, Week 26
Title
Change From Baseline In Index Knee Pain Intensity at Week 52
Description
The index knee pain intensity was assessed in 3 different ways using an 11 -point NRS (0 to 10 points representing 'no pain' to 'worst possible pain'). Subjects were asked to enter: 1) average pain intensity during the past week (7-day recall period); 2) the worst pain during activity over the past 24 hours; 3) pain intensity before and after a 40 meter walk (performance pain, before and after). The 40 meter fast paced walk test is a test of short distance walking activity, walking speed over short distances and changing direction during walking. Individuals taking the test should walk as quickly but as safely as possible, without running, along a walkway and then turn around, and repeat again for a total distance of 40 m (132 feet). The total time taken to walk the 40 meters is recorded.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Patient Global Assessment (PGA) of Arthritis of the Index Knee at Week 16
Description
The PGA is a single item for evaluating overall osteoarthritis disease activity. PGA is assessed using an 11-point NRS of 0 to 10 points (representing best to worst disease status, respectively), with a 7-day recall period.
Time Frame
Baseline, Week 16
Title
Change From Baseline in PGA of Arthritis of the Index Knee at Week 26
Description
The PGA is a single item for evaluating overall osteoarthritis disease activity. PGA is assessed using an 11-point NRS of 0 to 10 points (representing best to worst disease status, respectively), with a 7-day recall period.
Time Frame
Baseline, Week 26
Title
Change From Baseline in PGA of Arthritis of the Index Knee at Week 52
Description
The PGA is a single item for evaluating overall osteoarthritis disease activity. PGA is assessed using an 11-point NRS of 0 to 10 points (representing best to worst disease status, respectively), with a 7-day recall period.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Cartilage Volume of the Index Knee at Week 26
Description
Cartilage volume of the global knee, the medial central condyle + plateau, and the medial condyle + plateau was measured using MRI.
Time Frame
Baseline, Week 26
Title
Change From Baseline in Cartilage Volume of the Index Knee at Week 52
Description
Cartilage volume of the global knee, the medial central condyle + plateau, and the medial condyle + plateau was measured using MRI.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Cartilage Thickness of the Index Knee at Week 26
Description
Cartilage thickness of the global knee, the medial central condyle + plateau, and the medial condyle + plateau was measured using MRI.
Time Frame
Baseline, Week 26
Title
Change From Baseline in Cartilage Thickness of the Index Knee at Week 52
Description
Cartilage thickness of the global knee, the medial central condyle + plateau, and the medial condyle + plateau was measured using MRI.
Time Frame
Baseline, Week 52
Title
Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 16
Description
Percentage of participants classified as OMERACT-OARSI responders at Week 16. A subject was considered an OMERACT-OARSI responder if any of the following 3 criteria were met: 1. WOMAC Pain (in 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 2. WOMAC Function (in normalized 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 3. At least 2 of the following 3 are met: WOMAC Pain improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; WOMAC Function improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; PGA improvement ≥ 20% and absolute change (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline. Response rate 95% confidence interval based on normal approximation.
Time Frame
Week 16
Title
Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 26
Description
Percentage of participants classified as OMERACT-OARSI responders at Week 26. A subject was considered an OMERACT-OARSI responder if any of the following 3 criteria were met: 1. WOMAC Pain (in 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 2. WOMAC Function (in normalized 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 3. At least 2 of the following 3 are met: WOMAC Pain improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; WOMAC Function improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; PGA improvement ≥ 20% and absolute change (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline. Response rate 95% confidence interval based on normal approximation.
Time Frame
Week 26
Title
Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 52
Description
Percentage of participants classified as OMERACT-OARSI responders at Week 52. A subject was considered an OMERACT-OARSI responder if any of the following 3 criteria were met: 1. WOMAC Pain (in 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 2. WOMAC Function (in normalized 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 3. At least 2 of the following 3 are met: WOMAC Pain improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; WOMAC Function improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; PGA improvement ≥ 20% and absolute change (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline. Response rate 95% confidence interval based on normal approximation.
Time Frame
Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Radiographic knee osteoarthritis with Kellgren-Lawrence Grade 2 or 3
Body Mass Index (BMI) 18-34 kg/m2
One or more clinical signs and symptoms of active inflammation in the index knee
Exclusion Criteria:
History of allergic reaction to any constituents of the study drug, or to any Immunoglobulin G (IgG)-containing product
History of anaphylactic reaction to any agent
Significant trauma or surgery to the index knee
Severe knee malalignment
Any uncontrolled medical illness or an unstable treatment or therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Levesque, MD
Organizational Affiliation
AbbVie
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
30653843
Citation
Fleischmann RM, Bliddal H, Blanco FJ, Schnitzer TJ, Peterfy C, Chen S, Wang L, Feng S, Conaghan PG, Berenbaum F, Pelletier JP, Martel-Pelletier J, Vaeterlein O, Kaeley GS, Liu W, Kosloski MP, Levy G, Zhang L, Medema JK, Levesque MC. A Phase II Trial of Lutikizumab, an Anti-Interleukin-1alpha/beta Dual Variable Domain Immunoglobulin, in Knee Osteoarthritis Patients With Synovitis. Arthritis Rheumatol. 2019 Jul;71(7):1056-1069. doi: 10.1002/art.40840. Epub 2019 Jun 7.
Results Reference
derived
Learn more about this trial
A Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis
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