ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00296894
Recruitment Status : Completed
First Posted : February 27, 2006
Last Update Posted : February 9, 2009
Sponsor:
Information provided by:
University Hospital, Ghent

Brief Summary:

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 or disease Intervention/treatment Phase
Erosive Osteo-Arthritis Drug: Adalimumab (40 mg sc every other week) Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : May 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Adalimumab
U.S. FDA Resources

Arm Intervention/treatment
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



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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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

Additional Information:
Responsible Party: Gust Verbruggen, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00296894     History of Changes
Other Study ID Numbers: 2006/072
First Posted: February 27, 2006    Key Record Dates
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