NCT00296894

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 27, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 9, 2009

Status Verified

February 1, 2009

Enrollment Period

2.7 years

First QC Date

February 24, 2006

Last Update Submit

February 6, 2009

Conditions

Erosive Osteo-Arthritis

Outcome Measures

Primary Outcomes (2)

  • Evaluation of x-rays

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

Study Arms (2)

1

EXPERIMENTAL

Drug - adalimimab sc

Drug: Adalimumab (40 mg sc every other week)

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Adalimumab (40 mg sc every other week)DRUG

Adalimumab (40 mg sc every other week)

1
PlaceboDRUG

Placebo

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Gust Verbruggen, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 24, 2006

First Posted

February 27, 2006

Study Start

May 1, 2006

Primary Completion

January 1, 2009

Study Completion

February 1, 2009

Last Updated

February 9, 2009

Record last verified: 2009-02

Locations

BE(1)