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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00296894
First Posted: February 27, 2006
Last Update Posted: February 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Ghent
  Purpose

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.


Condition Intervention Phase
Erosive Osteo-Arthritis Drug: Adalimumab (40 mg sc every other week) Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Evaluation of x-rays
  • Evaluation of clinical parameters (pain, daily functioning, etc.)

Enrollment: 60
Study Start Date: May 2006
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug - adalimimab sc
Drug: Adalimumab (40 mg sc every other week)
Adalimumab (40 mg sc every other week)
Placebo Comparator: 2
Placebo
Drug: Placebo
Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clear erosive image on x-ray of at least one interphalangeal finger joint
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296894


Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Gust Verbruggen, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: Gust Verbruggen, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00296894     History of Changes
Other Study ID Numbers: 2006/072
First Submitted: February 24, 2006
First Posted: February 27, 2006
Last Update Posted: February 9, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents