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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:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00296894
First received: February 24, 2006
Last updated: February 6, 2009
Last verified: February 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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:

Drug Information available for: Adalimumab
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clear erosive image on x-ray of at least one interphalangeal finger joint
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Website University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Gust Verbruggen, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00296894     History of Changes
Other Study ID Numbers: 2006/072
Study First Received: February 24, 2006
Last Updated: February 6, 2009
Health Authority: Belgium: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013