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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02087904
Ethics application status
Date submitted
13/03/2014
Date registered
14/03/2014
Date last updated
28/08/2019

Titles & IDs
Public title
A 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
Treatment: Other - rFVIIIFc

Experimental: rFVIIIFc 1000 / 3000 PK Assessment - A single intravenous (IV) injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial followed by a single IV injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial.

Following the PK assessment, participants will receive either an episodic (on-demand) regimen with doses between 20 and 50 IU/kg based on the severity of the bleeding episode, or 1 of 2 prophylactic regimens: 50 IU/kg every 3 to 5 days or 65 IU/kg weekly. Participants will be allowed to switch from one regimen to another if approved by the Investigator.

Experimental: ABT-981 low dose - 25 mg ABT-981 subcutaneous (SC) every 2 weeks (E2W)

Experimental: ABT-981 medium dose - 100 mg ABT-981 SC E2W

Experimental: ABT-981 high dose - 200 mg ABT-981 SC E2W

Placebo comparator: Placebo - Placebo

Experimental: rFVIIIFc 3000 / 1000 PK Assessment - A single IV injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial followed by a single IV injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial.

Following the PK assessment, participants will receive either an episodic (on-demand) regimen with doses between 20 and 50 IU/kg based on the severity of the bleeding episode, or 1 of 2 prophylactic regimens: 50 IU/kg every 3 to 5 days or 65 IU/kg weekly. Participants will be allowed to switch from one regimen to another if approved by the Investigator.


Treatment: Other: rFVIIIFc
Administered as specified in the treatment arm.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16
Timepoint [1] 0 0
Baseline, Week 16
Primary outcome [2] 0 0
Change From Baseline in Quantitative Synovitis of the Index Knee at Week 26
Timepoint [2] 0 0
Baseline, Week 26
Primary outcome [3] 0 0
Change From Baseline in Effusion Volume of the Index Knee at Week 26
Timepoint [3] 0 0
Baseline, Week 26
Primary outcome [4] 0 0
Change From Baseline in Whole-Organ Magnetic Resonance Imaging Score (WORMS) Semi-Quantitative Synovitis/Effusion Score of the Index Knee at Week 26
Timepoint [4] 0 0
Baseline, Week 26
Secondary outcome [1] 0 0
Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 16
Timepoint [1] 0 0
Baseline, Week 16
Secondary outcome [2] 0 0
Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 26
Timepoint [2] 0 0
Baseline, Week 26
Secondary outcome [3] 0 0
Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 52
Timepoint [3] 0 0
Baseline, Week 52
Secondary outcome [4] 0 0
Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 26
Timepoint [4] 0 0
Baseline, Week 26
Secondary outcome [5] 0 0
Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 52
Timepoint [5] 0 0
Baseline, Week 52
Secondary outcome [6] 0 0
Change From Baseline in Global Total Bone Marrow Lesion (BML) Score of the Index Knee Magnetic Resonance Imaging (MRI) at Week 26
Timepoint [6] 0 0
Baseline, Week 26
Secondary outcome [7] 0 0
Change From Baseline in Global Total BML Score of the Index Knee MRI at Week 52
Timepoint [7] 0 0
Baseline, Week 52
Secondary outcome [8] 0 0
Change From Baseline in Index Knee Intermittent and Constant Osteoarthritis Pain (ICOAP) Scores at Week 16
Timepoint [8] 0 0
Baseline, Week 16
Secondary outcome [9] 0 0
Change From Baseline in Index Knee ICOAP Scores at Week 26
Timepoint [9] 0 0
Baseline, Week 26
Secondary outcome [10] 0 0
Change From Baseline in Index Knee ICOAP Scores at Week 52
Timepoint [10] 0 0
Baseline, Week 52
Secondary outcome [11] 0 0
Change From Baseline In Index Knee Pain Intensity at Week 16
Timepoint [11] 0 0
Baseline, Week 16
Secondary outcome [12] 0 0
Change From Baseline In Index Knee Pain Intensity at Week 26
Timepoint [12] 0 0
Baseline, Week 26
Secondary outcome [13] 0 0
Change From Baseline In Index Knee Pain Intensity at Week 52
Timepoint [13] 0 0
Baseline, Week 52
Secondary outcome [14] 0 0
Change From Baseline in Patient Global Assessment (PGA) of Arthritis of the Index Knee at Week 16
Timepoint [14] 0 0
Baseline, Week 16
Secondary outcome [15] 0 0
Change From Baseline in PGA of Arthritis of the Index Knee at Week 26
Timepoint [15] 0 0
Baseline, Week 26
Secondary outcome [16] 0 0
Change From Baseline in PGA of Arthritis of the Index Knee at Week 52
Timepoint [16] 0 0
Baseline, Week 52
Secondary outcome [17] 0 0
Change From Baseline in Cartilage Volume of the Index Knee at Week 26
Timepoint [17] 0 0
Baseline, Week 26
Secondary outcome [18] 0 0
Change From Baseline in Cartilage Volume of the Index Knee at Week 52
Timepoint [18] 0 0
Baseline, Week 52
Secondary outcome [19] 0 0
Change From Baseline in Cartilage Thickness of the Index Knee at Week 26
Timepoint [19] 0 0
Baseline, Week 26
Secondary outcome [20] 0 0
Change From Baseline in Cartilage Thickness of the Index Knee at Week 52
Timepoint [20] 0 0
Baseline, Week 52
Secondary outcome [21] 0 0
Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 16
Timepoint [21] 0 0
Week 16
Secondary outcome [22] 0 0
Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 26
Timepoint [22] 0 0
Week 26
Secondary outcome [23] 0 0
Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 52
Timepoint [23] 0 0
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
Sex
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
4. Severe knee malalignment
5. 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
4/06/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/12/2016
Sample size
Target
Accrual to date
Final
350
Recruitment in Australia
Recruitment state(s)

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02087904