Trial · NCT02087904
A Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis
NCT02087904, Phase 2, Completed, AbbVie; results first posted 2019-08-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis. Trials, record NCT02087904. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02087904
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis
- NCT number
- NCT02087904
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 350 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Knee Osteoarthritis, Medial Compartment Knee Osteoarthritis
- Interventions
- ABT-981, Placebo
- First posted
- 2014-03-14
- Last updated
- 2019-08-28
- Other registries' IDs
- eudract:2013-003467-60
- Results first posted
- 2019-08-28
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | Change From Baseline in Effusion Volume of the Index Knee at Week 26 | Baseline, Week 26 | |
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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). |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16 | Baseline, Week 16 | 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). | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Quantitative Synovitis of the Index Knee at Week 26 | Baseline, Week 26 | Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases. | mm | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Effusion Volume of the Index Knee at Week 26 | Baseline, Week 26 | Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases. | mL | LEAST_SQUARES_MEAN |
| PRIMARY | 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 | Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 16 | Baseline, Week 16 | 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). | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 26 | Baseline, Week 26 | 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). | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 52 | Baseline, Week 52 | 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). | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 26 | Baseline, Week 26 | 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). | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 52 | Baseline, Week 52 | 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). | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases. | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group188
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16 | Placebo | -8.9 | 95% Confidence Interval -10.96 to -6.90 | score on a scale | |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16 | ABT-981 25 mg | -9.2 | 95% Confidence Interval -11.23 to -7.23 | score on a scale | |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16 | ABT-981 100 mg | -11.8 | 95% Confidence Interval -13.84 to -9.75 | score on a scale | |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16 | ABT-981 200 mg | -10.1 | 95% Confidence Interval -12.10 to -8.10 | score on a scale | |
| Change From Baseline in Quantitative Synovitis of the Index Knee at Week 26 | Placebo | -0.05 | 95% Confidence Interval -0.107 to 0.011 | mm | |
| Change From Baseline in Quantitative Synovitis of the Index Knee at Week 26 | ABT-981 25 mg | 0.01 | 95% Confidence Interval -0.045 to 0.068 | mm | |
| Change From Baseline in Quantitative Synovitis of the Index Knee at Week 26 | ABT-981 100 mg | -0.08 | 95% Confidence Interval -0.134 to -0.016 | mm | |
| Change From Baseline in Quantitative Synovitis of the Index Knee at Week 26 | ABT-981 200 mg | 0.01 | 95% Confidence Interval -0.047 to 0.067 | mm | |
| Change From Baseline in Effusion Volume of the Index Knee at Week 26 | Placebo | 0.03 | 95% Confidence Interval -2.498 to 2.562 | mL | |
| Change From Baseline in Effusion Volume of the Index Knee at Week 26 | ABT-981 25 mg | 0.26 | 95% Confidence Interval -2.113 to 2.624 | mL |
1 to 10 of 188Source ClinicalTrials.gov
See all 188 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 85 | |
| Overall Study | STARTED | ABT-981 25 mg | 89 | |
| Overall Study | STARTED | ABT-981 100 mg | 87 | |
| Overall Study | STARTED | ABT-981 200 mg | 89 | |
| Overall Study | COMPLETED | Placebo | 60 | |
| Overall Study | COMPLETED | ABT-981 25 mg | 70 | |
| Overall Study | COMPLETED | ABT-981 100 mg | 65 | |
| Overall Study | COMPLETED | ABT-981 200 mg | 64 | |
| Overall Study | NOT COMPLETED | Placebo | 25 | |
| Overall Study | NOT COMPLETED | ABT-981 25 mg | 19 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events304
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | NEUTROPENIA | Blood and lymphatic system disorders | Placebo | 1 | 85 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | ABT-981 25 mg | 12 | 89 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | ABT-981 100 mg | 12 | 85 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | ABT-981 200 mg | 21 | 88 | |
| other | DIARRHOEA | Gastrointestinal disorders | Placebo | 7 | 85 | |
| other | DIARRHOEA | Gastrointestinal disorders | ABT-981 25 mg | 6 | 89 | |
| other | DIARRHOEA | Gastrointestinal disorders | ABT-981 100 mg | 5 | 85 | |
| other | DIARRHOEA | Gastrointestinal disorders | ABT-981 200 mg | 9 | 88 | |
| other | NAUSEA | Gastrointestinal disorders | Placebo | 3 | 85 | |
| other | NAUSEA | Gastrointestinal disorders | ABT-981 25 mg | 4 | 89 |
1 to 10 of 304Source ClinicalTrials.gov
See all 304 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | ABT-981 25 mg | ||
| Total, all-cause mortality | ABT-981 100 mg | ||
| Total, all-cause mortality | ABT-981 200 mg | ||
| Total, other adverse events | Placebo | 66 | 85 |
| Total, other adverse events | ABT-981 25 mg | 63 | 89 |
| Total, other adverse events | ABT-981 100 mg | 65 | 85 |
| Total, other adverse events | ABT-981 200 mg | 75 | 88 |
| Total, serious adverse events | Placebo | 8 | 85 |
| Total, serious adverse events | ABT-981 25 mg | 11 | 89 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30653843 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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