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

NCT ID: NCT00296894

Last Updated: 2009-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-02-28

Brief Summary

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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

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Conditions

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Erosive Osteo-Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Drug - adalimimab sc

Group Type EXPERIMENTAL

Adalimumab (40 mg sc every other week)

Intervention Type DRUG

Adalimumab (40 mg sc every other week)

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Adalimumab (40 mg sc every other week)

Adalimumab (40 mg sc every other week)

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clear erosive image on x-ray of at least one interphalangeal finger joint
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Ghent

Principal Investigators

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Gust Verbruggen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Website University Hospital Ghent

Other Identifiers

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2006/072

Identifier Type: -

Identifier Source: org_study_id

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