Comparison of Adalimumab and Infliximab Treatment of Rheu... | NCT00216177

Studies
Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis

NCT00216177

Sponsor

Hvidovre University Hospital

Status

Unknown status

Last Update Posted

Aug 18, 2009Estimated

Enrollment

112Estimated

Phase

Phase 4

Conditions

Rheumatoid Arthritis

Interventions

Infliximab
Adalimumab

Countries

Denmark

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

Aug 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Jan 2009Estimated

Completion Date

Jun 2009Estimated

First Submitted Date

Sep 20, 2005

First Submission Date that Met QC Criteria

Sep 20, 2005

First Posted Date

Sep 22, 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

Aug 17, 2009

Last Update Posted Date

Aug 18, 2009Estimated

Name	Class
University Hospital, Gentofte, Copenhagen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to establish whether RA patients with moderate to severe disease activity with unsustainable response to infliximab 3 mg/kg every 8 weeks have better efficacy with adalimumab 40 mg s.c. eow compared to infliximab 3 mg/kg i.v. every 6 weeks.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

112Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Infliximab	Drug	Remicade		remicade
Adalimumab	Drug	Humira		Humira

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients achieving combined good or moderate EULAR responses at week 24		six months

Secondary Outcomes

Measure	Description	Time Frame
ACR20/50/70 response at week 2, 6, 12, 18 and 24		six months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ACR criteria fulfilled,DAS28-3(CRP > 3.2
> 6 months prior treatment with infliximab 3 mg/kg i.v. every 8 week with initial response
Fading clinical response to infliximab
Negative pregnancy test (women with childbearing potential)
Use of reliable method of contraception (women with childbearing potential)
Informed consent

Exclusion Criteria:

Age less than 18 years
Lack of co-operability
Positive serology for hepatitis B or C
History of positive HIV status
History of TB or untreated latent TB
Histoplasmosis or Listeriosis
Pregnancy or breastfeeding
Persistent or recurrent infections
History of cancer
Uncontrolled diabetes
Ischaemic heart disease
Congestive heart failure (NYHA 3-4)
Active inflammatory bowel disease
Recent stroke (within 3 months)
History of or current inflammatory joint disease other than RA
Previous diagnosis or signs of central nervous system demyelinating disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Henrik Skjodt, MD, PhD	Contact	3632 3311		hskj@dadlnet.dk
Mikkel Ostergaard, MD, DMedSci	Contact			mo@dadlnet.dk

Overall Officials

Name	Affiliation	Role
Henrik Skjodt, MD, PhD	Hvidovre University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre Hospital	Recruiting	Copenhagen		2650	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

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
D000069285	Infliximab
D000068879	Adalimumab

Ancestor Terms

ID	Term
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
EudraCT no: 2005-001633-14
Switch/HUM 05-001