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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)

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee, osteoarthritis, pain, disease modifying

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All Sexes

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

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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