Study to Evaluate the Efficacy of Adalimumab in Patients... | NCT00296894

Studies
Study to Evaluate the Efficacy of Adalimumab in Patients With Erosive Osteoarthritis of the Interphalangeal Finger Joints

NCT00296894

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Feb 9, 2009Estimated

Enrollment

60Actual

Phase

Phase 2

Conditions

Erosive Osteo-Arthritis

Interventions

Adalimumab (40 mg sc every other week)
Placebo

Countries

Belgium

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

Official Title

TNF-Blockade for the Treatment of Erosive Osteoarthritis (OA) of Interphalangeal Finger Joints: Randomized, Double Blind, Placebo-Controlled Cross-Over Study to Evaluate the Efficacy of Adalimumab 40 mg SC Every Other Week in Patients With Erosive Osteoarthritis of the Interphalangeal Finger Joints

Status Module

Record Verification Date

Feb 2009

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

May 2006

Primary Completion Date

Jan 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

Feb 24, 2006

First Submission Date that Met QC Criteria

Feb 24, 2006

First Posted Date

Feb 27, 2006Estimated

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

Feb 6, 2009

Last Update Posted Date

Feb 9, 2009Estimated

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

Patients will be randomized into two groups (1/1) during one year:

40 mg adalimumab subcutaneously (sc) every other week
placebo

The effect on x-rays and clinical parameters will be evaluated.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Drug - adalimimab sc	Drug: Adalimumab (40 mg sc every other week)
2	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adalimumab (40 mg sc every other week)	Drug	Adalimumab (40 mg sc every other week)	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of x-rays
Evaluation of clinical parameters (pain, daily functioning, etc.)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clear erosive image on x-ray of at least one interphalangeal finger joint

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gust Verbruggen, MD, PhD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent		9000	Belgium

Label	URL
Website University Hospital Ghent	View source

Intervention Browse Module

MeSH Terms

ID	Term
D000068879	Adalimumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

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Browse Branches

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