Safety/Efficacy of Balicatib (AAE581) in Adults With Osteoarthritis of the Knee

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00371670
First received: August 31, 2006
Last updated: May 18, 2009
Last verified: May 2009
  Purpose

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


Condition Intervention Phase
Knee Osteoarthritis
Drug: balicatib (AAE581)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Enrollment: 223
Study Start Date: December 2004
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00371670

Locations
United States, Alabama
Pinnacle Research Group
Anniston, Alabama, United States, 36207
Germany
Novartis
Nuernberg, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00371670     History of Changes
Other Study ID Numbers: CAAE581C2201
Study First Received: August 31, 2006
Last Updated: May 18, 2009
Health Authority: United States: Food and Drug Administration
Belgium: Ministry of Social Affairs, Public Health and the Environment
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Novartis:
Knee, osteoarthritis, pain, disease modifying

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014