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

Erosive Osteo-Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296894
• Other study ID #: 2006/072
• Status: Completed
• Phase: Phase 2
• First received: February 24, 2006
• Last updated: February 6, 2009
• Start date: May 2006
• Est. completion date: February 2009

Study information

• Verified date: February 2009
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clear erosive image on x-ray of at least one interphalangeal finger joint

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erosive Osteo-Arthritis
• Osteoarthritis

Intervention

Drug:
• Adalimumab (40 mg sc every other week)
Adalimumab (40 mg sc every other week)
• Placebo
Placebo

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of x-rays
Primary	Evaluation of clinical parameters (pain, daily functioning, etc.)

External Links

•   Website University Hospital Ghent