Knee OsteoarthritisPhase 2NCT02087904

A Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis

A Phase 2 study testing ABT-981 in people with Knee Osteoarthritis and Medial Compartment Knee Osteoarthritis, run by AbbVie.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 35 to 74 years
Conditions the study is for: Knee Osteoarthritis, Medial Compartment Knee Osteoarthritis
What is being tested?: ABT-981
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 350 participants
Where: No sites listed yet
Study dates: 4 Jun 2014to 13 Dec 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

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

Conditions: Knee Osteoarthritis, Medial Compartment Knee Osteoarthritis
Being tested: ABT-981, Placebo
Keywords: Osteoarthritis, Synovitis, Knee, Pain
Medical subject headings: Osteoarthritis, Knee, Osteoarthritis, Synovitis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABT-981Biological
Also called Lutikizumab
PlaceboOther

Study groups in NCT02087904
Study group	Role	What they receive
ABT-981 low dose	Experimental	25 mg ABT-981 subcutaneous (SC) every 2 weeks (E2W) Receives: Biological: ABT-981
ABT-981 medium dose	Experimental	100 mg ABT-981 SC E2W Receives: Biological: ABT-981
ABT-981 high dose	Experimental	200 mg ABT-981 SC E2W Receives: Biological: ABT-981
Placebo	Placebo comparator	Placebo Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, Week 16
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.
Measured: Baseline, Week 26
Change From Baseline in Effusion Volume of the Index Knee at Week 26
Measured: 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
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).
Measured: Baseline, Week 26

Secondary outcomes (23)

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.
Measured: Baseline, Week 16
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.
Measured: Baseline, Week 26
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.
Measured: Baseline, Week 52
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.
Measured: Baseline, Week 26
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.
Measured: Baseline, Week 52
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).
Measured: Baseline, Week 26
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).
Measured: Baseline, Week 52
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).
Measured: Baseline, Week 16
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).
Measured: Baseline, Week 26
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).
Measured: Baseline, Week 52
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.
Measured: Baseline, Week 16
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.
Measured: Baseline, Week 26
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.
Measured: Baseline, Week 52
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.
Measured: Baseline, Week 16
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.
Measured: Baseline, Week 26
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.
Measured: Baseline, Week 52
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.
Measured: Baseline, Week 26
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.
Measured: Baseline, Week 52
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.
Measured: Baseline, Week 26
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.
Measured: Baseline, Week 52
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.
Measured: Week 16
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.
Measured: Week 26
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.
Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jun 201413 Dec 2016

First posted14 Mar 2014 (estimated)
Study start4 Jun 2014
Primary completion7 Jun 2016
Study completion13 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 350 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02087904
Sponsor's protocol ID: M13-741
Other IDs: 2013-003467-60
Status last verified: Jan 2017
First submitted: 13 Mar 2014
Last updated: 28 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 30653843

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee

All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis
ClinicalTrials.gov ID: NCT02087904
Acronym / sponsor ID: M13-741
Conditions: Knee Osteoarthritis, Medial Compartment Knee Osteoarthritis
Keywords: Osteoarthritis, Synovitis, Knee, Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 350 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 4 Jun 2014 (actual)
Primary completion: 7 Jun 2016 (actual)
Study completion: 13 Dec 2016 (actual)
First posted: 14 Mar 2014 (estimated)
Results: Posted 28 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
ABT-981 low dose	Experimental	Biological: ABT-98125 mg ABT-981 subcutaneous (SC) every 2 weeks (E2W)
ABT-981 medium dose	Experimental	Biological: ABT-981100 mg ABT-981 SC E2W
ABT-981 high dose	Experimental	Biological: ABT-981200 mg ABT-981 SC E2W
Placebo	Placebo comparator	Other: PlaceboPlacebo

Who may qualify

Ages: 35 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ABT-981Also: Lutikizumab	Biological	ABT-981 high dose, ABT-981 low dose, ABT-981 medium dose
Placebo	Other	Placebo

Primary outcome

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).

23 secondary outcomes

Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 16
Time frame: Baseline, Week 16
Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 26
Time frame: Baseline, Week 26
Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 52
Time frame: Baseline, Week 52
Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 26
Time frame: Baseline, Week 26
Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Global Total Bone Marrow Lesion (BML) Score of the Index Knee Magnetic Resonance Imaging (MRI) at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Global Total BML Score of the Index Knee MRI at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Index Knee Intermittent and Constant Osteoarthritis Pain (ICOAP) Scores at Week 16
Time frame: Baseline, Week 16
Change From Baseline in Index Knee ICOAP Scores at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Index Knee ICOAP Scores at Week 52
Time frame: Baseline, Week 52
Change From Baseline In Index Knee Pain Intensity at Week 16
Time frame: Baseline, Week 16
Change From Baseline In Index Knee Pain Intensity at Week 26
Time frame: Baseline, Week 26
Change From Baseline In Index Knee Pain Intensity at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Patient Global Assessment (PGA) of Arthritis of the Index Knee at Week 16
Time frame: Baseline, Week 16
Change From Baseline in PGA of Arthritis of the Index Knee at Week 26
Time frame: Baseline, Week 26
Change From Baseline in PGA of Arthritis of the Index Knee at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Cartilage Volume of the Index Knee at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Cartilage Volume of the Index Knee at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Cartilage Thickness of the Index Knee at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Cartilage Thickness of the Index Knee at Week 52
Time frame: Baseline, Week 52
Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 16
Time frame: Week 16
Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 26
Time frame: Week 26
Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 52
Time frame: Week 52

Results and safety

Results posted to the registry on 28 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	85	60
ABT-981 25 mg	89	70
ABT-981 100 mg	87	65
ABT-981 200 mg	89	64

Primary outcome: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16

Time frame: Baseline, Week 16. Least squares mean (95% Confidence Interval). Unit: score on a scale

Measure	Placebo n = 85	ABT-981 25 mg n = 88	ABT-981 100 mg n = 84	ABT-981 200 mg n = 88
Value	-8.9 (-10.96 to -6.90)	-9.2 (-11.23 to -7.23)	-11.8 (-13.84 to -9.75)	-10.1 (-12.10 to -8.10)

Placebo vs ABT-981 25 mg: LS Mean Difference: -0.3 (95% CI -3.13 to 2.53), p = 0.834, ANCOVA
Placebo vs ABT-981 100 mg: LS Mean Difference: -2.9 (95% CI -5.73 to 0.01), p = 0.05, ANCOVA
ABT-981 200 mg: LS Mean Difference: -1.2 (95% CI -4.00 to 1.66), p = 0.415, ANCOVA

Population analysed: 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).

Primary outcome: Change From Baseline in Quantitative Synovitis of the Index Knee at Week 26

Time frame: Baseline, Week 26. Least squares mean (95% Confidence Interval). Unit: mm

Measure	Placebo n = 59	ABT-981 25 mg n = 65	ABT-981 100 mg n = 59	ABT-981 200 mg n = 63
Value	-0.05 (-0.107 to 0.011)	0.01 (-0.045 to 0.068)	-0.08 (-0.134 to -0.016)	0.01 (-0.047 to 0.067)

Placebo vs ABT-981 25 mg: LS Mean Difference: 0.06 (95% CI -0.021 to 0.141), p = 0.145, ANCOVA
Placebo vs ABT-981 100 mg: LS Mean Difference: -0.03 (95% CI -0.11 to 0.056), p = 0.52, ANCOVA
Placebo vs ABT-981 200 mg: LS Mean Difference: 0.06 (95% CI -0.023 to 0.139), p = 0.159, ANCOVA

Population analysed: Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.

Primary outcome: Change From Baseline in Effusion Volume of the Index Knee at Week 26

Time frame: Baseline, Week 26. Least squares mean (95% Confidence Interval). Unit: mL

Measure	Placebo n = 60	ABT-981 25 mg n = 69	ABT-981 100 mg n = 67	ABT-981 200 mg n = 68
Value	0.03 (-2.498 to 2.562)	0.26 (-2.113 to 2.624)	-1.04 (-3.421 to 1.347)	-1.49 (-3.868 to 0.898)

Placebo vs ABT-981 25 mg: LS Mean Difference: 0.22 (95% CI -3.193 to 3.642), p = 0.897, ANCOVA
Placebo vs ABT-981 100 mg: LS Mean Difference: -1.07 (95% CI -4.515 to 2.377), p = 0.542, ANCOVA
Placebo vs ABT-981 200 mg: LS Mean Difference: -1.52 (95% CI -4.95 to 1.916), p = 0.385, ANCOVA

Population analysed: Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.

Primary outcome: Change From Baseline in Whole-Organ Magnetic Resonance Imaging Score (WORMS) Semi-Quantitative Synovitis/Effusion Score of the Index Knee at Week 26

Time frame: Baseline, Week 26. Least squares mean (95% Confidence Interval). Unit: score on a scale

Measure	Placebo n = 70	ABT-981 25 mg n = 76	ABT-981 100 mg n = 70	ABT-981 200 mg n = 75
Value	0.07 (-0.057 to 0.193)	-0.01 (-0.130 to 0.113)	-0.08 (-0.205 to 0.043)	-0.07 (-0.196 to 0.048)

Placebo vs ABT-981 25 mg: LS Mean Difference: -0.08 (95% CI -0.249 to 0.096), p = 0.384, ANCOVA
Placebo vs ABT-981 100 mg: LS Mean Difference: -0.15 (95% CI -0.324 to 0.026), p = 0.095, ANCOVA
Placebo vs ABT-981 200 mg: LS Mean Difference: -0.14 (95% CI -0.314 to 0.03), p = 0.106, ANCOVA

Population analysed: Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.

23 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to Week 52 (or last dose of study drug) plus 70 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	8 of 85 (9.4%)	66 of 85 (77.6%)	Not reported
ABT-981 25 mg	11 of 89 (12.4%)	63 of 89 (70.8%)	Not reported
ABT-981 100 mg	8 of 85 (9.4%)	65 of 85 (76.5%)	Not reported
ABT-981 200 mg	4 of 88 (4.5%)	75 of 88 (85.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30653843Fleischmann 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.

Related trials for Knee Osteoarthritis

Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marc Levesque, MD study chair

AbbVie

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-981 in people with Knee Osteoarthritis and Medial Compartment Knee Osteoarthritis, run by AbbVie.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16 (time frame: Baseline, Week 16). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02087904, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.