Safety/Efficacy of Balicatib (AAE581) in Adults With Osteoarthritis of the Knee
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
balicatib (AAE581)
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee, osteoarthritis, pain, disease modifying
Eligibility Criteria
Inclusion Criteria:
- At least one knee with osteoarthritis with Kellgren-Lawrence grade 3
- Significant osteoarthritis pain in the knee
- Presence of at least one of the risk factors: obesity (BMI > 28), osteoarthritis at other sites, knee effusion, family history of total joint replacement
Exclusion Criteria:
- Women with childbearing potential
- Secondary osteoarthritis
- Treatment with intra-articular or systemic steroids
- Inability to undergo MRI acquisition
Other protocol defined inclusion/exclusion criteria may apply.
Sites / Locations
- Pinnacle Research Group
- Novartis
Outcomes
Primary Outcome Measures
Change from baseline in knee cartilage volume in the target compartment after 6 months
Secondary Outcome Measures
Change from baseline in:
- Cartilage volume in the different regions of the knee after 6 and 12 months,
- Cartilage score (Whole Organ MRI Scoring system (WORMS)) in the different regions of the knee after 6 and 12 months,
- Bone marrow edema score (WORMS) in the different regions of the knee after 6 and 12 months,
- Joint space width after 6 and 12 months,
- Markers of bone and cartilage degradation (CTX-I and CTX-II at 3, 6, 9, and 12 months
- Pain (analgesic consumption, Western Ontario and McMaster Universities Osteoarthritis Index, Visual Analogue Scale, criteria of the Outcome Measures in Rheumatology Osteoarthritis-Research Society International at 1, 3, 6, 9, and 12 months
Full Information
NCT ID
NCT00371670
First Posted
August 31, 2006
Last Updated
March 24, 2017
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00371670
Brief Title
Safety/Efficacy of Balicatib (AAE581) in Adults With Osteoarthritis of the Knee
Official Title
A Phase II, 12-month, Double-blind, Placebo-controlled, Dose-finding, Multicenter Study to Evaluate the Safety, Tolerability, and Disease Modifying Efficacy of Daily Oral AAE581 (10, 25 and 50 mg Tablets) in Patients With Painful Knee Osteoarthritis, Kellgren-Lawrence Grade 3 by X-ray
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
This study will test efficacy and safety of AAE581 compared to placebo in limiting cartilage loss in patients with painful knee osteoarthritis which is confirmed by X-ray
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee, osteoarthritis, pain, disease modifying
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
223 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
balicatib (AAE581)
Primary Outcome Measure Information:
Title
Change from baseline in knee cartilage volume in the target compartment after 6 months
Secondary Outcome Measure Information:
Title
Change from baseline in:
Title
- Cartilage volume in the different regions of the knee after 6 and 12 months,
Title
- Cartilage score (Whole Organ MRI Scoring system (WORMS)) in the different regions of the knee after 6 and 12 months,
Title
- Bone marrow edema score (WORMS) in the different regions of the knee after 6 and 12 months,
Title
- Joint space width after 6 and 12 months,
Title
- Markers of bone and cartilage degradation (CTX-I and CTX-II at 3, 6, 9, and 12 months
Title
- Pain (analgesic consumption, Western Ontario and McMaster Universities Osteoarthritis Index, Visual Analogue Scale, criteria of the Outcome Measures in Rheumatology Osteoarthritis-Research Society International at 1, 3, 6, 9, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Eligibility Criteria
Inclusion Criteria:
At least one knee with osteoarthritis with Kellgren-Lawrence grade 3
Significant osteoarthritis pain in the knee
Presence of at least one of the risk factors: obesity (BMI > 28), osteoarthritis at other sites, knee effusion, family history of total joint replacement
Exclusion Criteria:
Women with childbearing potential
Secondary osteoarthritis
Treatment with intra-articular or systemic steroids
Inability to undergo MRI acquisition
Other protocol defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Novartis
City
Nuernberg
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Safety/Efficacy of Balicatib (AAE581) in Adults With Osteoarthritis of the Knee
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