- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00296894
Study to Evaluate the Efficacy of Adalimumab in Patients With Erosive Osteoarthritis of the Interphalangeal Finger Joints
February 6, 2009 updated by: University Hospital, Ghent
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ghent, Belgium, 9000
- University Hospital Ghent
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clear erosive image on x-ray of at least one interphalangeal finger joint
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
Placebo
|
Placebo
|
Experimental: 1
Drug - adalimimab sc
|
Adalimumab (40 mg sc every other week)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Evaluation of x-rays
|
Evaluation of clinical parameters (pain, daily functioning, etc.)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gust Verbruggen, MD, PhD, University Hospital, Ghent
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
February 24, 2006
First Submitted That Met QC Criteria
February 24, 2006
First Posted (Estimate)
February 27, 2006
Study Record Updates
Last Update Posted (Estimate)
February 9, 2009
Last Update Submitted That Met QC Criteria
February 6, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006/072
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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