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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02087904




Registration number
NCT02087904
Ethics application status
Date submitted
13/03/2014
Date registered
14/03/2014
Date last updated
29/08/2017

Titles & IDs
Public title
A Phase 2a Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis
Scientific title
A Phase 2a Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis
Secondary ID [1] 0 0
2013-003467-60
Secondary ID [2] 0 0
M13-741
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 0 0
Medial Compartment Knee Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - ABT-981
Other interventions - Placebo

Active Comparator: ABT-981 low dose - Low dose

Active Comparator: ABT-981 medium dose - Medium dose

Active Comparator: ABT-981 high dose - High dose

Placebo Comparator: Placebo - Placebo


Other interventions: ABT-981


Other interventions: Placebo


Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes in Pain Score of the index knee - It is evaluated using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Timepoint [1] 0 0
From Day 1 to Week 16
Primary outcome [2] 0 0
Change in synovitis/effusion volume of the index knee - It is evaluated using quantitative and semiquantitative Magnetic Resonance Imaging (MRI) measurements.
Timepoint [2] 0 0
From Day 1 to Week 26
Secondary outcome [1] 0 0
Change in physical function - It is evaluated using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Timepoint [1] 0 0
From Day 1 to Week 52
Secondary outcome [2] 0 0
Change in index knee pain - It is evaluated using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Timepoint [2] 0 0
From Day 1 to Week 52
Secondary outcome [3] 0 0
Change in bone marrow lesions of the index knee - It is evaluated in Magnetic Resonance Imaging (MRI).
Timepoint [3] 0 0
From Day 1 to Week 52
Secondary outcome [4] 0 0
Change in index knee Intermittent and Constant Pain - It is evaluated using the Intermittent and Constant Osteoarthritis Pain (ICOAP) score
Timepoint [4] 0 0
From Day 1 to Week 52

Eligibility
Key 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
Minimum age
35 Years
Maximum age
74 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

3. Severe knee malalignment 4. Any uncontrolled medical illness or an unstable treatment or
therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site Reference ID/Investigator# 128791 - Maroochydore
Recruitment hospital [2] 0 0
Site Reference ID/Investigator# 121698 - St Leonards
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Hawaii
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United States of America
State/province [6] 0 0
Illinois
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United States of America
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Kansas
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Nevada
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United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
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Rhode Island
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Washington
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Canada
State/province [22] 0 0
Edmonton
Country [23] 0 0
Canada
State/province [23] 0 0
Kitchener
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Canada
State/province [24] 0 0
Montreal
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Canada
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Quebec City
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Canada
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Quebec
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Canada
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Victoria
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Denmark
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Aarhus C
Country [29] 0 0
Denmark
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Frederiksberg
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Denmark
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Vejle
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France
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Montpellier
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France
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Paris
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France
State/province [33] 0 0
Vandoeuvre les Nancy
Country [34] 0 0
Italy
State/province [34] 0 0
Catania
Country [35] 0 0
Italy
State/province [35] 0 0
Pavia
Country [36] 0 0
Italy
State/province [36] 0 0
Rome
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Italy
State/province [37] 0 0
Verona
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Mexico
State/province [38] 0 0
Chihuahua
Country [39] 0 0
Mexico
State/province [39] 0 0
Guadalajara, Jalisco
Country [40] 0 0
Mexico
State/province [40] 0 0
Leon
Country [41] 0 0
Mexico
State/province [41] 0 0
Mexico, D.F.
Country [42] 0 0
Mexico
State/province [42] 0 0
Monterrey
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Netherlands
State/province [43] 0 0
Leiden
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Netherlands
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Utrecht
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Puerto Rico
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Carolina
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Puerto Rico
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Ponce
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Puerto Rico
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San Juan
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Spain
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La Coruna
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Spain
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Santander, Cantabria
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Spain
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Santiago de Compostela
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Spain
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Seville
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United Kingdom
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Cambridge
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United Kingdom
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Dudley

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02087904
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marc Levesque, MD
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications