Knee Osteoarthritis, Medial Compartment Knee Osteoarthritis
Conditions
Keywords
Osteoarthritis, Synovitis, Knee, Pain
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.
Interventions
BIOLOGICALABT-981
OTHERPlacebo
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
1. Radiographic knee osteoarthritis with Kellgren-Lawrence Grade 2 or 3 2. Body Mass Index (BMI) 18-34 kg/m2 3. One or more clinical signs and symptoms of active inflammation in the index knee
Exclusion criteria
1. History of allergic reaction to any constituents of the study drug, or to any Immunoglobulin G (IgG)-containing product 2. History of anaphylactic reaction to any agent 3. Significant trauma or surgery to the index knee 4. Severe knee malalignment 5. Any uncontrolled medical illness or an unstable treatment or therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16 | Baseline, 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 | Baseline, 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 | Baseline, 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 | Baseline, 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 52 | Baseline, 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 | Baseline, 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 | Baseline, 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 | Baseline, 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 | Baseline, 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 | Baseline, 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 | Baseline, 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 | Baseline, 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 | Baseline, 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 WOMAC Physical Function Scores of the Index Knee at Week 16 | Baseline, 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 PGA of Arthritis of the Index Knee at Week 26 | Baseline, 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 | Baseline, 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 | Baseline, 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 | Baseline, 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 | Baseline, 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 | Baseline, 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 | 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 | 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 | 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. |
| Change From Baseline in Patient Global Assessment (PGA) of Arthritis of the Index Knee at Week 16 | Baseline, 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 WOMAC Physical Function Scores of the Index Knee at Week 26 | Baseline, 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 | Baseline, 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 | Baseline, 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. |
Participant flow
Pre-assignment details
The study included a screening period (approximately 45 days prior to first study drug dose) and a washout period (5 half-lives of the longest acting analgesic used, or 48 hours, whichever was longer, in which all standard of care analgesic medications were discontinued prior to the first study drug dose).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Matching placebo SC E2W | 85 |
| ABT-981 25 mg 25 mg ABT-981 SC E2W | 89 |
| ABT-981 100 mg 100 mg ABT-981 SC E2W | 85 |
| ABT-981 200 mg 200 mg ABT-981 SC E2W | 88 |
| Total | 347 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 8 | 4 | 4 | 12 |
| Overall Study | Did Not Receive Study Drug | 0 | 0 | 2 | 1 |
| Overall Study | Lack of Efficacy | 3 | 6 | 3 | 2 |
| Overall Study | Lost to Follow-up | 0 | 4 | 2 | 2 |
| Overall Study | Other | 6 | 2 | 4 | 4 |
| Overall Study | Withdrawal by Subject | 8 | 3 | 7 | 4 |
Baseline characteristics
| Characteristic | Placebo | ABT-981 25 mg | ABT-981 100 mg | ABT-981 200 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 59.53 years STANDARD_DEVIATION 8.85 | 61.63 years STANDARD_DEVIATION 7.546 | 60.21 years STANDARD_DEVIATION 8.194 | 59.05 years STANDARD_DEVIATION 10.273 | 60.11 years STANDARD_DEVIATION 8.792 |
| Sex: Female, Male Female | 52 Participants | 63 Participants | 53 Participants | 57 Participants | 225 Participants |
| Sex: Female, Male Male | 33 Participants | 26 Participants | 32 Participants | 31 Participants | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 66 / 85 | 63 / 89 | 65 / 85 | 75 / 88 |
| serious Total, serious adverse events | 8 / 85 | 11 / 89 | 8 / 85 | 4 / 88 |
Outcome results
Primary
Change From Baseline in Effusion Volume of the Index Knee at Week 26
Time frame: Baseline, Week 26
Population: Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Effusion Volume of the Index Knee at Week 26 | 0.03 mL |
| ABT-981 25 mg | Change From Baseline in Effusion Volume of the Index Knee at Week 26 | 0.26 mL |
| ABT-981 100 mg | Change From Baseline in Effusion Volume of the Index Knee at Week 26 | -1.04 mL |
| ABT-981 200 mg | Change From Baseline in Effusion Volume of the Index Knee at Week 26 | -1.49 mL |
p-value: 0.89795% CI: [-3.193, 3.642]ANCOVA
p-value: 0.54295% CI: [-4.515, 2.377]ANCOVA
p-value: 0.38595% CI: [-4.95, 1.916]ANCOVA
Primary
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.
Time frame: Baseline, Week 26
Population: Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Quantitative Synovitis of the Index Knee at Week 26 | -0.05 mm |
| ABT-981 25 mg | Change From Baseline in Quantitative Synovitis of the Index Knee at Week 26 | 0.01 mm |
| ABT-981 100 mg | Change From Baseline in Quantitative Synovitis of the Index Knee at Week 26 | -0.08 mm |
| ABT-981 200 mg | Change From Baseline in Quantitative Synovitis of the Index Knee at Week 26 | 0.01 mm |
p-value: 0.15995% CI: [-0.023, 0.139]ANCOVA
p-value: 0.14595% CI: [-0.021, 0.141]ANCOVA
p-value: 0.5295% CI: [-0.11, 0.056]ANCOVA
Primary
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.
Time frame: Baseline, Week 16
Population: Modified Intent to Treat population: all subjects who received at least 1 dose of study drug, Last observation carried forward (LOCF; missing responses were imputed by calculation based on the last non-missing post-baseline component values).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16 | -8.9 score on a scale |
| ABT-981 25 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16 | -9.2 score on a scale |
| ABT-981 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16 | -11.8 score on a scale |
| ABT-981 200 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16 | -10.1 score on a scale |
p-value: 0.0595% CI: [-5.73, 0.01]ANCOVA
p-value: 0.41595% CI: [-4, 1.66]ANCOVA
p-value: 0.83495% CI: [-3.13, 2.53]ANCOVA
Primary
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).
Time frame: Baseline, Week 26
Population: Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Whole-Organ Magnetic Resonance Imaging Score (WORMS) Semi-Quantitative Synovitis/Effusion Score of the Index Knee at Week 26 | 0.07 score on a scale |
| ABT-981 25 mg | Change From Baseline in Whole-Organ Magnetic Resonance Imaging Score (WORMS) Semi-Quantitative Synovitis/Effusion Score of the Index Knee at Week 26 | -0.01 score on a scale |
| ABT-981 100 mg | Change From Baseline in Whole-Organ Magnetic Resonance Imaging Score (WORMS) Semi-Quantitative Synovitis/Effusion Score of the Index Knee at Week 26 | -0.08 score on a scale |
| ABT-981 200 mg | Change From Baseline in Whole-Organ Magnetic Resonance Imaging Score (WORMS) Semi-Quantitative Synovitis/Effusion Score of the Index Knee at Week 26 | -0.07 score on a scale |
p-value: 0.38495% CI: [-0.249, 0.096]ANCOVA
p-value: 0.09595% CI: [-0.324, 0.026]ANCOVA
p-value: 0.10695% CI: [-0.314, 0.03]ANCOVA
Secondary
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.
Time frame: Baseline, Week 26
Population: Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in Cartilage Thickness of the Index Knee at Week 26 | Global Knee | -0.047 mm |
| Placebo | Change From Baseline in Cartilage Thickness of the Index Knee at Week 26 | Medial Condyle + Plateau | -0.046 mm |
| Placebo | Change From Baseline in Cartilage Thickness of the Index Knee at Week 26 | Medial Central Condyle + Plateau | -0.085 mm |
| ABT-981 25 mg | Change From Baseline in Cartilage Thickness of the Index Knee at Week 26 | Global Knee | -0.047 mm |
| ABT-981 25 mg | Change From Baseline in Cartilage Thickness of the Index Knee at Week 26 | Medial Condyle + Plateau | -0.045 mm |
| ABT-981 25 mg | Change From Baseline in Cartilage Thickness of the Index Knee at Week 26 | Medial Central Condyle + Plateau | -0.077 mm |
| ABT-981 100 mg | Change From Baseline in Cartilage Thickness of the Index Knee at Week 26 | Medial Central Condyle + Plateau | -0.074 mm |
| ABT-981 100 mg | Change From Baseline in Cartilage Thickness of the Index Knee at Week 26 | Global Knee | -0.048 mm |
| ABT-981 100 mg | Change From Baseline in Cartilage Thickness of the Index Knee at Week 26 | Medial Condyle + Plateau | -0.047 mm |
| ABT-981 200 mg | Change From Baseline in Cartilage Thickness of the Index Knee at Week 26 | Global Knee | -0.052 mm |
| ABT-981 200 mg | Change From Baseline in Cartilage Thickness of the Index Knee at Week 26 | Medial Condyle + Plateau | -0.044 mm |
| ABT-981 200 mg | Change From Baseline in Cartilage Thickness of the Index Knee at Week 26 | Medial Central Condyle + Plateau | -0.076 mm |
Comparison: Global kneep-value: 0.97295% CI: [-0.015, 0.015]ANCOVA
Comparison: Global kneep-value: 0.92995% CI: [-0.017, 0.015]ANCOVA
Comparison: Global kneep-value: 0.54395% CI: [-0.02, 0.01]ANCOVA
Comparison: Medial central condyle + plateaup-value: 0.75295% CI: [-0.043, 0.059]ANCOVA
Comparison: Medial central condyle + plateaup-value: 0.69195% CI: [-0.042, 0.064]ANCOVA
Comparison: Medial central condyle + plateaup-value: 0.7195% CI: [-0.041, 0.06]ANCOVA
Comparison: Medial condyle + plateaup-value: 0.96595% CI: [-0.019, 0.02]ANCOVA
Comparison: Medial condyle + plateaup-value: 0.88595% CI: [-0.022, 0.019]ANCOVA
Comparison: Medial condyle + plateaup-value: 0.88795% CI: [-0.018, 0.021]ANCOVA
Secondary
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.
Time frame: Baseline, Week 52
Population: Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in Cartilage Thickness of the Index Knee at Week 52 | Medial Condyle + Plateau | -0.084 mm |
| Placebo | Change From Baseline in Cartilage Thickness of the Index Knee at Week 52 | Global Knee | -0.081 mm |
| Placebo | Change From Baseline in Cartilage Thickness of the Index Knee at Week 52 | Medial Central Condyle + Plateau | -0.136 mm |
| ABT-981 25 mg | Change From Baseline in Cartilage Thickness of the Index Knee at Week 52 | Global Knee | -0.085 mm |
| ABT-981 25 mg | Change From Baseline in Cartilage Thickness of the Index Knee at Week 52 | Medial Central Condyle + Plateau | -0.176 mm |
| ABT-981 25 mg | Change From Baseline in Cartilage Thickness of the Index Knee at Week 52 | Medial Condyle + Plateau | -0.096 mm |
| ABT-981 100 mg | Change From Baseline in Cartilage Thickness of the Index Knee at Week 52 | Medial Condyle + Plateau | -0.073 mm |
| ABT-981 100 mg | Change From Baseline in Cartilage Thickness of the Index Knee at Week 52 | Medial Central Condyle + Plateau | -0.113 mm |
| ABT-981 100 mg | Change From Baseline in Cartilage Thickness of the Index Knee at Week 52 | Global Knee | -0.081 mm |
| ABT-981 200 mg | Change From Baseline in Cartilage Thickness of the Index Knee at Week 52 | Medial Condyle + Plateau | -0.087 mm |
| ABT-981 200 mg | Change From Baseline in Cartilage Thickness of the Index Knee at Week 52 | Medial Central Condyle + Plateau | -0.141 mm |
| ABT-981 200 mg | Change From Baseline in Cartilage Thickness of the Index Knee at Week 52 | Global Knee | -0.083 mm |
Comparison: Global kneep-value: 0.61995% CI: [-0.024, 0.014]ANCOVA
Comparison: Global kneep-value: 0.95295% CI: [-0.02, 0.019]ANCOVA
Comparison: Global kneep-value: 0.76595% CI: [-0.022, 0.016]ANCOVA
Comparison: Medial central condyle + plateaup-value: 0.25895% CI: [-0.11, 0.03]ANCOVA
Comparison: Medial central condyle + plateaup-value: 0.53595% CI: [-0.049, 0.094]ANCOVA
Comparison: Medial central condyle + plateaup-value: 0.86695% CI: [-0.076, 0.064]ANCOVA
Comparison: Medial condyle + plateaup-value: 0.41395% CI: [-0.041, 0.017]ANCOVA
Comparison: Medial condyle + plateaup-value: 0.44595% CI: [-0.018, 0.042]ANCOVA
Comparison: Medial condyle + plateaup-value: 0.83595% CI: [-0.032, 0.026]ANCOVA
Secondary
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.
Time frame: Baseline, Week 26
Population: Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in Cartilage Volume of the Index Knee at Week 26 | Global Knee | -326.0 mm^3 |
| Placebo | Change From Baseline in Cartilage Volume of the Index Knee at Week 26 | Medial Condyle + Plateau | -128.6 mm^3 |
| Placebo | Change From Baseline in Cartilage Volume of the Index Knee at Week 26 | Medial Central Condyle + Plateau | -59.1 mm^3 |
| ABT-981 25 mg | Change From Baseline in Cartilage Volume of the Index Knee at Week 26 | Global Knee | -325.5 mm^3 |
| ABT-981 25 mg | Change From Baseline in Cartilage Volume of the Index Knee at Week 26 | Medial Condyle + Plateau | -126.5 mm^3 |
| ABT-981 25 mg | Change From Baseline in Cartilage Volume of the Index Knee at Week 26 | Medial Central Condyle + Plateau | -54.9 mm^3 |
| ABT-981 100 mg | Change From Baseline in Cartilage Volume of the Index Knee at Week 26 | Medial Central Condyle + Plateau | -50.1 mm^3 |
| ABT-981 100 mg | Change From Baseline in Cartilage Volume of the Index Knee at Week 26 | Global Knee | -322.4 mm^3 |
| ABT-981 100 mg | Change From Baseline in Cartilage Volume of the Index Knee at Week 26 | Medial Condyle + Plateau | -124.5 mm^3 |
| ABT-981 200 mg | Change From Baseline in Cartilage Volume of the Index Knee at Week 26 | Global Knee | -359.0 mm^3 |
| ABT-981 200 mg | Change From Baseline in Cartilage Volume of the Index Knee at Week 26 | Medial Condyle + Plateau | -114.9 mm^3 |
| ABT-981 200 mg | Change From Baseline in Cartilage Volume of the Index Knee at Week 26 | Medial Central Condyle + Plateau | -57.5 mm^3 |
Comparison: Global kneep-value: 0.99295% CI: [-101.59, 102.62]ANCOVA
Comparison: Global kneep-value: 0.94895% CI: [-103.95, 111.1]ANCOVA
Comparison: Global kneep-value: 0.52395% CI: [-134.76, 68.65]ANCOVA
Comparison: Medial central condyle + plateaup-value: 0.79995% CI: [-28.47, 36.95]ANCOVA
Comparison: Medial central condyle + plateaup-value: 0.60995% CI: [-25.62, 43.64]ANCOVA
Comparison: Medial central condyle + plateaup-value: 0.92395% CI: [-30.97, 34.19]ANCOVA
Comparison: Medial condyle + plateaup-value: 0.93795% CI: [-49.88, 54.08]ANCOVA
Comparison: Medial condyle + plateaup-value: 0.88295% CI: [-50.68, 58.95]ANCOVA
Comparison: Medial condyle + plateaup-value: 0.60295% CI: [-38.05, 65.55]ANCOVA
Secondary
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.
Time frame: Baseline, Week 52
Population: Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in Cartilage Volume of the Index Knee at Week 52 | Medial Condyle + Plateau | -214.7 mm^3 |
| Placebo | Change From Baseline in Cartilage Volume of the Index Knee at Week 52 | Global Knee | -557.0 mm^3 |
| Placebo | Change From Baseline in Cartilage Volume of the Index Knee at Week 52 | Medial Central Condyle + Plateau | -101.2 mm^3 |
| ABT-981 25 mg | Change From Baseline in Cartilage Volume of the Index Knee at Week 52 | Medial Condyle + Plateau | -255.0 mm^3 |
| ABT-981 25 mg | Change From Baseline in Cartilage Volume of the Index Knee at Week 52 | Medial Central Condyle + Plateau | -126.3 mm^3 |
| ABT-981 25 mg | Change From Baseline in Cartilage Volume of the Index Knee at Week 52 | Global Knee | -598.7 mm^3 |
| ABT-981 100 mg | Change From Baseline in Cartilage Volume of the Index Knee at Week 52 | Medial Central Condyle + Plateau | -90.1 mm^3 |
| ABT-981 100 mg | Change From Baseline in Cartilage Volume of the Index Knee at Week 52 | Global Knee | -554.3 mm^3 |
| ABT-981 100 mg | Change From Baseline in Cartilage Volume of the Index Knee at Week 52 | Medial Condyle + Plateau | -190.3 mm^3 |
| ABT-981 200 mg | Change From Baseline in Cartilage Volume of the Index Knee at Week 52 | Global Knee | -583.1 mm^3 |
| ABT-981 200 mg | Change From Baseline in Cartilage Volume of the Index Knee at Week 52 | Medial Central Condyle + Plateau | -113.0 mm^3 |
| ABT-981 200 mg | Change From Baseline in Cartilage Volume of the Index Knee at Week 52 | Medial Condyle + Plateau | -242.8 mm^3 |
Comparison: Global kneep-value: 0.55495% CI: [-180.49, 97.04]ANCOVA
Comparison: Global kneep-value: 0.9795% CI: [-140.86, 146.31]ANCOVA
Comparison: Global kneep-value: 0.71395% CI: [-165.47, 113.32]ANCOVA
Comparison: Medial central condyle + plateaup-value: 0.27295% CI: [-70.12, 19.88]ANCOVA
Comparison: Medial central condyle + plateaup-value: 0.6495% CI: [-35.63, 57.8]ANCOVA
Comparison: Medial central condyle + plateaup-value: 0.60895% CI: [-56.94, 33.38]ANCOVA
Comparison: Medial condyle + plateaup-value: 0.31995% CI: [-119.88, 39.3]ANCOVA
Comparison: Medial condyle + plateaup-value: 0.5695% CI: [-58.05, 106.91]ANCOVA
Comparison: Medial condyle + plateaup-value: 0.48995% CI: [-107.97, 51.82]ANCOVA
Secondary
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).
Time frame: Baseline, Week 52
Population: Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Global Total BML Score of the Index Knee MRI at Week 52 | 0.1 score on a scale |
| ABT-981 25 mg | Change From Baseline in Global Total BML Score of the Index Knee MRI at Week 52 | 0.2 score on a scale |
| ABT-981 100 mg | Change From Baseline in Global Total BML Score of the Index Knee MRI at Week 52 | 0.1 score on a scale |
| ABT-981 200 mg | Change From Baseline in Global Total BML Score of the Index Knee MRI at Week 52 | 0.0 score on a scale |
p-value: 0.60295% CI: [-0.41, 0.7]ANCOVA
p-value: 0.95395% CI: [-0.55, 0.58]ANCOVA
p-value: 0.8395% CI: [-0.61, 0.49]ANCOVA
Secondary
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).
Time frame: Baseline, Week 26
Population: Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Global Total Bone Marrow Lesion (BML) Score of the Index Knee Magnetic Resonance Imaging (MRI) at Week 26 | 0.1 score on a scale |
| ABT-981 25 mg | Change From Baseline in Global Total Bone Marrow Lesion (BML) Score of the Index Knee Magnetic Resonance Imaging (MRI) at Week 26 | 0.3 score on a scale |
| ABT-981 100 mg | Change From Baseline in Global Total Bone Marrow Lesion (BML) Score of the Index Knee Magnetic Resonance Imaging (MRI) at Week 26 | -0.0 score on a scale |
| ABT-981 200 mg | Change From Baseline in Global Total Bone Marrow Lesion (BML) Score of the Index Knee Magnetic Resonance Imaging (MRI) at Week 26 | 0.1 score on a scale |
p-value: 0.31995% CI: [-0.23, 0.69]ANCOVA
p-value: 0.56495% CI: [-0.6, 0.33]ANCOVA
p-value: 0.96695% CI: [-0.45, 0.47]ANCOVA
Secondary
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).
Time frame: Baseline, Week 26
Population: Modified Intent to Treat population: all subjects who received at least 1 dose of study drug, observed cases.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in Index Knee ICOAP Scores at Week 26 | Constant Pain | -19.6 score on a scale |
| Placebo | Change From Baseline in Index Knee ICOAP Scores at Week 26 | Intermittent Pain | -18.7 score on a scale |
| ABT-981 25 mg | Change From Baseline in Index Knee ICOAP Scores at Week 26 | Intermittent Pain | -19.7 score on a scale |
| ABT-981 25 mg | Change From Baseline in Index Knee ICOAP Scores at Week 26 | Constant Pain | -18.8 score on a scale |
| ABT-981 100 mg | Change From Baseline in Index Knee ICOAP Scores at Week 26 | Intermittent Pain | -21.3 score on a scale |
| ABT-981 100 mg | Change From Baseline in Index Knee ICOAP Scores at Week 26 | Constant Pain | -21.6 score on a scale |
| ABT-981 200 mg | Change From Baseline in Index Knee ICOAP Scores at Week 26 | Intermittent Pain | -21.7 score on a scale |
| ABT-981 200 mg | Change From Baseline in Index Knee ICOAP Scores at Week 26 | Constant Pain | -22.1 score on a scale |
Comparison: Intermittent painp-value: 0.7595% CI: [-7.14, 5.14]ANCOVA
Comparison: Intermittent painp-value: 0.40995% CI: [-8.82, 3.6]ANCOVA
Comparison: Intermittent painp-value: 0.33895% CI: [-9.24, 3.18]ANCOVA
Comparison: Constant painp-value: 0.81795% CI: [-5.59, 7.08]ANCOVA
Comparison: Constant painp-value: 0.54495% CI: [-8.37, 4.43]ANCOVA
Comparison: Constant painp-value: 0.43795% CI: [-8.91, 3.86]ANCOVA
Secondary
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).
Time frame: Baseline, Week 52
Population: Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in Index Knee ICOAP Scores at Week 52 | Intermittent Pain | -23.2 score on a scale |
| Placebo | Change From Baseline in Index Knee ICOAP Scores at Week 52 | Constant Pain | -20.6 score on a scale |
| ABT-981 25 mg | Change From Baseline in Index Knee ICOAP Scores at Week 52 | Constant Pain | -21.8 score on a scale |
| ABT-981 25 mg | Change From Baseline in Index Knee ICOAP Scores at Week 52 | Intermittent Pain | -25.4 score on a scale |
| ABT-981 100 mg | Change From Baseline in Index Knee ICOAP Scores at Week 52 | Intermittent Pain | -23.6 score on a scale |
| ABT-981 100 mg | Change From Baseline in Index Knee ICOAP Scores at Week 52 | Constant Pain | -25.2 score on a scale |
| ABT-981 200 mg | Change From Baseline in Index Knee ICOAP Scores at Week 52 | Intermittent Pain | -27.2 score on a scale |
| ABT-981 200 mg | Change From Baseline in Index Knee ICOAP Scores at Week 52 | Constant Pain | -29.7 score on a scale |
Comparison: Intermittent painp-value: 0.54595% CI: [-9.31, 4.92]ANCOVA
Comparison: Intermittent painp-value: 0.90995% CI: [-7.65, 6.81]ANCOVA
Comparison: Intermittent painp-value: 0.27895% CI: [-11.23, 3.25]ANCOVA
Comparison: Constant painp-value: 0.73295% CI: [-8.42, 5.92]ANCOVA
Comparison: Constant painp-value: 0.21695% CI: [-11.86, 2.69]ANCOVA
Comparison: Constant painp-value: 0.01495% CI: [-16.42, -1.88]ANCOVA
Secondary
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).
Time frame: Baseline, Week 16
Population: Modified Intent to Treat population: all subjects who received at least 1 dose of study drug, observed cases.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in Index Knee Intermittent and Constant Osteoarthritis Pain (ICOAP) Scores at Week 16 | Intermittent Pain | -20.2 score on a scale |
| Placebo | Change From Baseline in Index Knee Intermittent and Constant Osteoarthritis Pain (ICOAP) Scores at Week 16 | Constant Pain | -18.6 score on a scale |
| ABT-981 25 mg | Change From Baseline in Index Knee Intermittent and Constant Osteoarthritis Pain (ICOAP) Scores at Week 16 | Constant Pain | -17.7 score on a scale |
| ABT-981 25 mg | Change From Baseline in Index Knee Intermittent and Constant Osteoarthritis Pain (ICOAP) Scores at Week 16 | Intermittent Pain | -19.5 score on a scale |
| ABT-981 100 mg | Change From Baseline in Index Knee Intermittent and Constant Osteoarthritis Pain (ICOAP) Scores at Week 16 | Intermittent Pain | -21.3 score on a scale |
| ABT-981 100 mg | Change From Baseline in Index Knee Intermittent and Constant Osteoarthritis Pain (ICOAP) Scores at Week 16 | Constant Pain | -24.2 score on a scale |
| ABT-981 200 mg | Change From Baseline in Index Knee Intermittent and Constant Osteoarthritis Pain (ICOAP) Scores at Week 16 | Intermittent Pain | -18.8 score on a scale |
| ABT-981 200 mg | Change From Baseline in Index Knee Intermittent and Constant Osteoarthritis Pain (ICOAP) Scores at Week 16 | Constant Pain | -20.0 score on a scale |
Comparison: Intermittent painp-value: 0.80495% CI: [-4.91, 6.33]ANCOVA
Comparison: Intermittent painp-value: 0.69995% CI: [-6.9, 4.63]ANCOVA
Comparison: Intermittent painp-value: 0.63695% CI: [-4.37, 7.14]ANCOVA
Comparison: Constant painp-value: 0.75695% CI: [-4.91, 6.76]ANCOVA
Comparison: Constant painp-value: 0.06895% CI: [-11.55, 0.42]ANCOVA
Comparison: Constant painp-value: 0.64995% CI: [-7.34, 4.58]ANCOVA
Secondary
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.
Time frame: Baseline, Week 16
Population: Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline In Index Knee Pain Intensity at Week 16 | 7-Day Recall Period | -2.4 units on a scale |
| Placebo | Change From Baseline In Index Knee Pain Intensity at Week 16 | Activity Pain | -2.3 units on a scale |
| Placebo | Change From Baseline In Index Knee Pain Intensity at Week 16 | Performance Pain (After) | -2.6 units on a scale |
| Placebo | Change From Baseline In Index Knee Pain Intensity at Week 16 | Performance Pain (Before) | -2.4 units on a scale |
| ABT-981 25 mg | Change From Baseline In Index Knee Pain Intensity at Week 16 | Activity Pain | -2.4 units on a scale |
| ABT-981 25 mg | Change From Baseline In Index Knee Pain Intensity at Week 16 | Performance Pain (After) | -2.4 units on a scale |
| ABT-981 25 mg | Change From Baseline In Index Knee Pain Intensity at Week 16 | 7-Day Recall Period | -2.4 units on a scale |
| ABT-981 25 mg | Change From Baseline In Index Knee Pain Intensity at Week 16 | Performance Pain (Before) | -2.1 units on a scale |
| ABT-981 100 mg | Change From Baseline In Index Knee Pain Intensity at Week 16 | 7-Day Recall Period | -2.7 units on a scale |
| ABT-981 100 mg | Change From Baseline In Index Knee Pain Intensity at Week 16 | Performance Pain (After) | -2.7 units on a scale |
| ABT-981 100 mg | Change From Baseline In Index Knee Pain Intensity at Week 16 | Performance Pain (Before) | -2.5 units on a scale |
| ABT-981 100 mg | Change From Baseline In Index Knee Pain Intensity at Week 16 | Activity Pain | -2.7 units on a scale |
| ABT-981 200 mg | Change From Baseline In Index Knee Pain Intensity at Week 16 | Performance Pain (After) | -2.3 units on a scale |
| ABT-981 200 mg | Change From Baseline In Index Knee Pain Intensity at Week 16 | Performance Pain (Before) | -2.1 units on a scale |
| ABT-981 200 mg | Change From Baseline In Index Knee Pain Intensity at Week 16 | Activity Pain | -2.1 units on a scale |
| ABT-981 200 mg | Change From Baseline In Index Knee Pain Intensity at Week 16 | 7-Day Recall Period | -2.1 units on a scale |
Comparison: 7-day recall periodp-value: 0.87495% CI: [-0.56, 0.66]ANCOVA
Comparison: 7-day recall periodp-value: 0.45195% CI: [-0.86, 0.38]ANCOVA
Comparison: 7-day recall periodp-value: 0.33195% CI: [-0.31, 0.93]ANCOVA
Comparison: Activity painp-value: 0.93295% CI: [-0.73, 0.67]ANCOVA
Comparison: Activity painp-value: 0.34495% CI: [-1.07, 0.37]ANCOVA
Comparison: Activity painp-value: 0.48995% CI: [-0.47, 0.97]ANCOVA
Comparison: Performance pain (before)p-value: 0.49895% CI: [-0.42, 0.85]ANCOVA
Comparison: Performance pain (before)p-value: 0.63795% CI: [-0.8, 0.49]ANCOVA
Comparison: Performance pain (before)p-value: 0.36795% CI: [-0.35, 0.94]ANCOVA
Comparison: Performance pain (after)p-value: 0.6795% CI: [-0.51, 0.79]ANCOVA
Comparison: Performance pain (after)p-value: 0.77695% CI: [-0.76, 0.57]ANCOVA
Comparison: Performance pain (after)p-value: 0.38795% CI: [-0.37, 0.96]ANCOVA
Secondary
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.
Time frame: Baseline, Week 26
Population: Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline In Index Knee Pain Intensity at Week 26 | Performance Pain (Before) | -2.2 units on a scale |
| Placebo | Change From Baseline In Index Knee Pain Intensity at Week 26 | 7-Day Recall Period | -2.2 units on a scale |
| Placebo | Change From Baseline In Index Knee Pain Intensity at Week 26 | Activity Pain | -2.5 units on a scale |
| Placebo | Change From Baseline In Index Knee Pain Intensity at Week 26 | Performance Pain (After) | -2.5 units on a scale |
| ABT-981 25 mg | Change From Baseline In Index Knee Pain Intensity at Week 26 | Performance Pain (After) | -2.4 units on a scale |
| ABT-981 25 mg | Change From Baseline In Index Knee Pain Intensity at Week 26 | Performance Pain (Before) | -2.2 units on a scale |
| ABT-981 25 mg | Change From Baseline In Index Knee Pain Intensity at Week 26 | 7-Day Recall Period | -2.4 units on a scale |
| ABT-981 25 mg | Change From Baseline In Index Knee Pain Intensity at Week 26 | Activity Pain | -2.5 units on a scale |
| ABT-981 100 mg | Change From Baseline In Index Knee Pain Intensity at Week 26 | Activity Pain | -2.8 units on a scale |
| ABT-981 100 mg | Change From Baseline In Index Knee Pain Intensity at Week 26 | 7-Day Recall Period | -2.8 units on a scale |
| ABT-981 100 mg | Change From Baseline In Index Knee Pain Intensity at Week 26 | Performance Pain (Before) | -2.6 units on a scale |
| ABT-981 100 mg | Change From Baseline In Index Knee Pain Intensity at Week 26 | Performance Pain (After) | -3.0 units on a scale |
| ABT-981 200 mg | Change From Baseline In Index Knee Pain Intensity at Week 26 | Activity Pain | -2.5 units on a scale |
| ABT-981 200 mg | Change From Baseline In Index Knee Pain Intensity at Week 26 | 7-Day Recall Period | -2.5 units on a scale |
| ABT-981 200 mg | Change From Baseline In Index Knee Pain Intensity at Week 26 | Performance Pain (After) | -2.6 units on a scale |
| ABT-981 200 mg | Change From Baseline In Index Knee Pain Intensity at Week 26 | Performance Pain (Before) | -2.7 units on a scale |
Comparison: 7-day recall periodp-value: 0.66195% CI: [-0.86, 0.54]ANCOVA
Comparison: 7-day recall periodp-value: 0.12295% CI: [-1.26, 0.15]ANCOVA
Comparison: 7-day recall periodp-value: 0.50795% CI: [-0.94, 0.47]ANCOVA
Comparison: Activity painp-value: 0.89295% CI: [-0.85, 0.74]ANCOVA
Comparison: Activity painp-value: 0.43395% CI: [-1.12, 0.48]ANCOVA
Comparison: Activity painp-value: 0.9295% CI: [-0.84, 0.76]ANCOVA
Comparison: Performance pain (before)p-value: 0.95795% CI: [-0.68, 0.71]ANCOVA
Comparison: Performance pain (before)p-value: 0.22295% CI: [-1.13, 0.26]ANCOVA
Comparison: Performance pain (before)p-value: 0.20995% CI: [-1.15, 0.25]ANCOVA
Comparison: Performance pain (after)p-value: 0.81395% CI: [-0.62, 0.79]ANCOVA
Comparison: Performance pain (after)p-value: 0.13595% CI: [-1.25, 0.17]ANCOVA
Comparison: Performance pain (after)p-value: 0.67995% CI: [-0.85, 0.57]ANCOVA
Secondary
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.
Time frame: Baseline, Week 52
Population: Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline In Index Knee Pain Intensity at Week 52 | Activity Pain | -2.8 units on a scale |
| Placebo | Change From Baseline In Index Knee Pain Intensity at Week 52 | Performance Pain (Before) | -2.6 units on a scale |
| Placebo | Change From Baseline In Index Knee Pain Intensity at Week 52 | 7-Day Recall Period | -2.9 units on a scale |
| Placebo | Change From Baseline In Index Knee Pain Intensity at Week 52 | Performance Pain (After) | -2.9 units on a scale |
| ABT-981 25 mg | Change From Baseline In Index Knee Pain Intensity at Week 52 | Performance Pain (After) | -3.0 units on a scale |
| ABT-981 25 mg | Change From Baseline In Index Knee Pain Intensity at Week 52 | Performance Pain (Before) | -2.7 units on a scale |
| ABT-981 25 mg | Change From Baseline In Index Knee Pain Intensity at Week 52 | 7-Day Recall Period | -2.9 units on a scale |
| ABT-981 25 mg | Change From Baseline In Index Knee Pain Intensity at Week 52 | Activity Pain | -3.0 units on a scale |
| ABT-981 100 mg | Change From Baseline In Index Knee Pain Intensity at Week 52 | Performance Pain (After) | -3.4 units on a scale |
| ABT-981 100 mg | Change From Baseline In Index Knee Pain Intensity at Week 52 | 7-Day Recall Period | -2.9 units on a scale |
| ABT-981 100 mg | Change From Baseline In Index Knee Pain Intensity at Week 52 | Activity Pain | -3.2 units on a scale |
| ABT-981 100 mg | Change From Baseline In Index Knee Pain Intensity at Week 52 | Performance Pain (Before) | -3.0 units on a scale |
| ABT-981 200 mg | Change From Baseline In Index Knee Pain Intensity at Week 52 | 7-Day Recall Period | -3.1 units on a scale |
| ABT-981 200 mg | Change From Baseline In Index Knee Pain Intensity at Week 52 | Performance Pain (Before) | -2.9 units on a scale |
| ABT-981 200 mg | Change From Baseline In Index Knee Pain Intensity at Week 52 | Performance Pain (After) | -3.2 units on a scale |
| ABT-981 200 mg | Change From Baseline In Index Knee Pain Intensity at Week 52 | Activity Pain | -3.0 units on a scale |
Comparison: 7-day recall periodp-value: 0.97895% CI: [-0.76, 0.79]ANCOVA
Comparison: 7-day recall periodp-value: 0.92595% CI: [-0.75, 0.82]ANCOVA
Comparison: 7-day recall periodp-value: 0.65995% CI: [-0.96, 0.61]ANCOVA
Comparison: Activity painp-value: 0.63395% CI: [-1.1, 0.67]ANCOVA
Comparison: Activity painp-value: 0.4695% CI: [-1.23, 0.56]ANCOVA
Comparison: Activity painp-value: 0.66395% CI: [-1.1, 0.7]ANCOVA
Comparison: Performance pain (before)p-value: 0.69695% CI: [-0.89, 0.59]ANCOVA
Comparison: Performance pain (before)p-value: 0.27895% CI: [-1.16, 0.34]ANCOVA
Comparison: Performance pain (before)p-value: 0.35795% CI: [-1.1, 0.4]ANCOVA
Comparison: Performance pain (after)p-value: 0.76195% CI: [-0.87, 0.64]ANCOVA
p-value: 0.21895% CI: [-1.02, 0.51]ANCOVA
Comparison: Performance pain (after)p-value: 0.51395% CI: [-1.02, 0.51]ANCOVA
Secondary
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.
Time frame: Baseline, Week 16
Population: Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Patient Global Assessment (PGA) of Arthritis of the Index Knee at Week 16 | -2.5 units on a scale |
| ABT-981 25 mg | Change From Baseline in Patient Global Assessment (PGA) of Arthritis of the Index Knee at Week 16 | -2.4 units on a scale |
| ABT-981 100 mg | Change From Baseline in Patient Global Assessment (PGA) of Arthritis of the Index Knee at Week 16 | -2.9 units on a scale |
| ABT-981 200 mg | Change From Baseline in Patient Global Assessment (PGA) of Arthritis of the Index Knee at Week 16 | -2.6 units on a scale |
p-value: 0.72895% CI: [-0.52, 0.75]ANCOVA
p-value: 0.21995% CI: [-1.06, 0.24]ANCOVA
p-value: 0.67395% CI: [-0.79, 0.51]ANCOVA
Secondary
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.
Time frame: Baseline, Week 26
Population: Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in PGA of Arthritis of the Index Knee at Week 26 | -2.4 units on a scale |
| ABT-981 25 mg | Change From Baseline in PGA of Arthritis of the Index Knee at Week 26 | -2.4 units on a scale |
| ABT-981 100 mg | Change From Baseline in PGA of Arthritis of the Index Knee at Week 26 | -3.0 units on a scale |
| ABT-981 200 mg | Change From Baseline in PGA of Arthritis of the Index Knee at Week 26 | -2.7 units on a scale |
p-value: 0.98495% CI: [-0.73, 0.71]ANCOVA
p-value: 0.14595% CI: [-1.26, 0.19]ANCOVA
p-value: 0.52795% CI: [-0.96, 0.49]ANCOVA
Secondary
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.
Time frame: Baseline, Week 52
Population: Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in PGA of Arthritis of the Index Knee at Week 52 | -3.0 units on a scale |
| ABT-981 25 mg | Change From Baseline in PGA of Arthritis of the Index Knee at Week 52 | -2.9 units on a scale |
| ABT-981 100 mg | Change From Baseline in PGA of Arthritis of the Index Knee at Week 52 | -3.2 units on a scale |
| ABT-981 200 mg | Change From Baseline in PGA of Arthritis of the Index Knee at Week 52 | -3.5 units on a scale |
p-value: 0.83695% CI: [-0.71, 0.87]ANCOVA
p-value: 0.73895% CI: [-0.94, 0.66]ANCOVA
p-value: 0.395% CI: [-1.22, 0.38]ANCOVA
Secondary
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.
Time frame: Baseline, Week 26
Population: Modified intent to Treat population: all subjects who received at least 1 dose of study drug, LOCF (missing responses were imputed by calculation based on the last non-missing post-baseline component values).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 26 | -9.2 score on a scale |
| ABT-981 25 mg | Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 26 | -9.8 score on a scale |
| ABT-981 100 mg | Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 26 | -11.9 score on a scale |
| ABT-981 200 mg | Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 26 | -11.6 score on a scale |
p-value: 0.66495% CI: [-3.58, 2.28]ANCOVA
p-value: 0.07595% CI: [-5.67, 0.28]ANCOVA
p-value: 0.10795% CI: [-5.33, 0.52]ANCOVA
Secondary
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.
Time frame: Baseline, Week 52
Population: Modified intent to Treat population: all participants who received at least 1 dose of study drug, LOCF (missing responses were imputed by calculation based on the last non-missing post-baseline component values).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 52 | -10.0 score on a scale |
| ABT-981 25 mg | Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 52 | -11.0 score on a scale |
| ABT-981 100 mg | Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 52 | -12.1 score on a scale |
| ABT-981 200 mg | Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 52 | -12.2 score on a scale |
p-value: 0.595% CI: [-4.26, 2.08]ANCOVA
p-value: 0.18695% CI: [-5.39, 1.05]ANCOVA
p-value: 0.15795% CI: [-5.46, 0.88]ANCOVA
Secondary
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.
Time frame: Baseline, Week 16
Population: Modified intent to Treat population: all participants who received at least 1 dose of study drug, LOCF (missing responses were imputed by calculation based on the last non-missing post-baseline component values).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 16 | -28.7 score on a scale |
| ABT-981 25 mg | Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 16 | -29.8 score on a scale |
| ABT-981 100 mg | Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 16 | -36.3 score on a scale |
| ABT-981 200 mg | Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 16 | -32.1 score on a scale |
p-value: 0.81895% CI: [-10.22, 8.08]ANCOVA
p-value: 0.10995% CI: [-16.83, 1.69]ANCOVA
p-value: 0.46595% CI: [-12.58, 5.76]ANCOVA
Secondary
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.
Time frame: Baseline, Week 26
Population: Modified Intent to Treat population: all participants who received at least 1 dose of study drug, LOCF (missing responses were imputed by calculation based on the last non-missing post-baseline component values).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 26 | -29.7 score on a scale |
| ABT-981 25 mg | Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 26 | -31.8 score on a scale |
| ABT-981 100 mg | Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 26 | -38.9 score on a scale |
| ABT-981 200 mg | Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 26 | -36.9 score on a scale |
p-value: 0.66695% CI: [-11.76, 7.52]ANCOVA
p-value: 0.06595% CI: [-18.95, 0.56]ANCOVA
p-value: 0.14595% CI: [-16.84, 2.49]ANCOVA
Secondary
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.
Time frame: Baseline, Week 52
Population: Modified Intent to Treat population: all participants who received at least 1 dose of study drug, LOCF (missing responses were imputed by calculation based on the last non-missing post-baseline component values).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 52 | -32.9 score on a scale |
| ABT-981 25 mg | Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 52 | -36.1 score on a scale |
| ABT-981 100 mg | Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 52 | -38.7 score on a scale |
| ABT-981 200 mg | Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 52 | -39.7 score on a scale |
p-value: 0.55895% CI: [-14.03, 7.59]ANCOVA
p-value: 0.29595% CI: [-16.77, 5.11]ANCOVA
p-value: 0.21895% CI: [-17.63, 4.04]ANCOVA
Secondary
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.
Time frame: Week 16
Population: Modified Intent to Treat population: all participants who received at least 1 dose of study drug, LOCF.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 16 | 60.0 percentage of participants |
| ABT-981 25 mg | Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 16 | 67.0 percentage of participants |
| ABT-981 100 mg | Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 16 | 72.6 percentage of participants |
| ABT-981 200 mg | Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 16 | 65.5 percentage of participants |
p-value: 0.31195% CI: [-7.3, 21.4]Cochran-Mantel-Haenszel
p-value: 0.43595% CI: [-8.9, 19.9]Cochran-Mantel-Haenszel
p-value: 0.43595% CI: [-8.9, 19.9]Cochran-Mantel-Haenszel
Secondary
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.
Time frame: Week 26
Population: Modified Intent to Treat population: all participants who received at least 1 dose of study drug, LOCF.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 26 | 62.4 percentage of participants |
| ABT-981 25 mg | Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 26 | 64.8 percentage of participants |
| ABT-981 100 mg | Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 26 | 66.7 percentage of participants |
| ABT-981 200 mg | Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 26 | 72.7 percentage of participants |
p-value: 0.74495% CI: [-11.9, 16.8]Cochran-Mantel-Haenszel
p-value: 0.58195% CI: [-10.1, 18.7]Cochran-Mantel-Haenszel
p-value: 0.14695% CI: [-3.5, 24.3]Cochran-Mantel-Haenszel
Secondary
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.
Time frame: Week 52
Population: Modified Intent to Treat population: all participants who received at least 1 dose of study drug, LOCF.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 52 | 70.6 percentage of participants |
| ABT-981 25 mg | Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 52 | 69.3 percentage of participants |
| ABT-981 100 mg | Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 52 | 71.4 percentage of participants |
| ABT-981 200 mg | Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 52 | 72.7 percentage of participants |
p-value: 0.82495% CI: [-14.9, 12.4]Cochran-Mantel-Haenszel
p-value: 0.96495% CI: [-12.8, 14.5]Cochran-Mantel-Haenszel
p-value: 0.76395% CI: [-11.3, 15.6]Cochran-Mantel-Haenszel