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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 19, 2014