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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
History of Changes
  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:

U.S. FDA Resources

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 May 19, 2013