Investigation of Specific Protein/Markers in Patients Wit... | NCT01611441

Studies
Investigation of Specific Protein/Markers in Patients With Osteoarthritis of the Knee Having a Total Knee Replacement

NCT01611441

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jun 27, 2012Estimated

Enrollment

125Actual

Phase

Not provided

Conditions

Osteoarthritis of the Knee

Interventions

Not provided

Countries

Canada
Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
D2285M00029

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

May 31, 2012

First Submission Date that Met QC Criteria

Jun 4, 2012

First Posted Date

Jun 5, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2012

Last Update Posted Date

Jun 27, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The main purpose of the study is to better understand how specific proteins/markers in blood, urine, synovial fluid (a lubricating fluid secreted by the membrane lining the joints), and joint tissue are involved in osteoarthritis of the knee. The aim is to investigate if there is a correlation between x-ray results, specific proteins/markers and different types of pain in patients with osteoarthritis of the knee. The study consists of 3 visits over 3-20 days and the last visit will be the day of surgery.

Detailed Description

Investigation of Biomarkers in an Exploratory Study in Patients with Osteoarthritis of the Knee Undergoing Total Knee Replacement Surgery

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

125Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with osteoarthritis of the knee		Patients with osteoarthritis of the knee undergoing total knee replacement surgery.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients with upregulation of IL-6 or the IL-6 signalling pathway in the knee.		3-20 days prior to day 1 (surgery) and day 1 (surgery) .

Secondary Outcomes

Measure	Description	Time Frame
Biomarkers in synovial fluid, synovial membrane, and cartilage.		Day 1 (surgery).
Biomarkers in blood and urine.		3-20 days prior to day 1 (surgery) and day 1 (surgery).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who will undergo a total knee replacement due to osteoarthritis.
Symptoms of the knee for at least 6 months prior to study start.

Exclusion Criteria:

Key-hole surgery performed on target knee within 3 months prior to study start.
History of disorders in which part of the immune system is missing or defective.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Primary and secondary care clinics

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rolf Karlsten, MD, PHD	AstraZeneca R&D Sodertalje, Sweden	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Montreal			Canada
Research Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28333699	Derived	Radojcic MR, Thudium CS, Henriksen K, Tan K, Karlsten R, Dudley A, Chessell I, Karsdal MA, Bay-Jensen AC, Crema MD, Guermazi A. Biomarker of extracellular matrix remodelling C1M and proinflammatory cytokine interleukin 6 are related to synovitis and pain in end-stage knee osteoarthritis patients. Pain. 2017 Jul;158(7):1254-1263. doi: 10.1097/j.pain.0000000000000908.

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases