NCT00185562

Brief Summary

A 12 week trial of Adalimumab in subjects with active erosive inflammatory OA who have ahd an inadequate response to NSAID therapy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2005

Shorter than P25 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

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

March 24, 2006

Status Verified

March 1, 2006

First QC Date

September 9, 2005

Last Update Submit

March 23, 2006

Conditions

Osteoarthritis

Keywords

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Safety

Secondary Outcomes (1)

  • 20% ACR response

Interventions

AdalimumabDRUG

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 45 or older, \>/=2 tender and 2 swollen joints, inadequate response to NSAID therapy, hand radiographs with evidence of erosive changes, acceptable form of birth control

You may not qualify if:

  • Autoimmune arthropathy, History of psoriasis, Previous TNF therapy, current use of any DMARD, evidence of TB, history of Hep C, B, or HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Mark C Genovese, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

June 1, 2005

Study Completion

January 1, 2006

Last Updated

March 24, 2006

Record last verified: 2006-03

Locations

US(1)