A Pilot Trial of Adalimumab for the Treatment of Osteoart... | NCT00185562

Studies
A Pilot Trial of Adalimumab for the Treatment of Osteoarthritis

NCT00185562

Sponsor

Stanford University

Status

Completed

Last Update Posted

Mar 24, 2006Estimated

Enrollment

Phase

Phase 2

Conditions

Osteoarthritis

Interventions

Adalimumab

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Not provided

Completion Date

Jan 2006

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2006

Last Update Posted Date

Mar 24, 2006Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Adalimumab	Drug

Measure	Description	Time Frame
Safety

Measure	Description	Time Frame
20% ACR response

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark C Genovese, MD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University		Stanford	California	94305	United States

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068879	Adalimumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided