NCT00371670

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

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for phase_2 knee-osteoarthritis

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

1.6 years

First QC Date

August 31, 2006

Last Update Submit

March 24, 2017

Conditions

Knee Osteoarthritis

Keywords

Knee, osteoarthritis, pain, disease modifying

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in knee cartilage volume in the target compartment after 6 months

Secondary Outcomes (7)

  • 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,

  • +2 more secondary outcomes

Interventions

balicatib (AAE581)DRUG

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Women with childbearing potential
  • Secondary osteoarthritis
  • Treatment with intra-articular or systemic steroids
  • Inability to undergo MRI acquisition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pinnacle Research Group

Anniston, Alabama, 36207, United States

Location

Novartis

Nuremberg, Germany

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisPain

Interventions

balicatib

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 31, 2006

First Posted

September 4, 2006

Study Start

December 1, 2004

Primary Completion

July 1, 2006

Last Updated

March 28, 2017

Record last verified: 2017-03

Locations

DE(1)US(1)