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CompletedNCT00296894Updated Feb 9, 2009

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

A Phase 2 interventional study of Adalimumab (40 mg sc every other week) and Placebo in Erosive Osteo-Arthritis, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-02-09.

Sponsored by University Hospital, Ghent · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Erosive Osteo-Arthritis

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03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 60 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

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Lead sponsor

University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Clear erosive image on x-ray of at least one interphalangeal finger joint
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    1

    Drug - adalimimab sc

    Drug: Adalimumab (40 mg sc every other week)

  • Placebo comparator
    2

    Placebo

    Drug: Placebo

Interventions

  • DrugAdalimumab (40 mg sc every other week)

    Adalimumab (40 mg sc every other week)

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Evaluation of x-rays

  2. Evaluation of clinical parameters (pain, daily functioning, etc.)

07

Study locations

1 site
  • University Hospital Ghent
    Ghent, 9000, Belgium
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00296894
Lead sponsor
University Hospital, Ghent
First posted
Feb 27, 2006
Start date
May 2006
Primary completion
Jan 2009
Completion
Feb 2009
Last update
Feb 9, 2009

Study contacts

Gust Verbruggen, MD, PhD
principal investigator · University Hospital, Ghent

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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