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Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Infliximab
Adalimumab
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hvidovre HospitalRecruiting
  • Bispebjerg HospitalRecruiting
  • Gentofte AmtssygehusRecruiting
  • Glostrup HospitalRecruiting
  • RigshospitaletRecruiting
  • Graasten GigthospitalRecruiting

Outcomes

Primary Outcome Measures

Proportion of patients achieving combined good or moderate EULAR responses at week 24

Secondary Outcome Measures

ACR20/50/70 response at week 2, 6, 12, 18 and 24

Full Information

First Posted
September 20, 2005
Last Updated
August 17, 2009
Sponsor
Hvidovre University Hospital
Collaborators
University Hospital, Gentofte, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT00216177
Brief Title
Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis
Official Title
Randomised, Multicenter, Open-label, Parallel-group Study Comparing Adalimumab 40 mg s.c. Eow Versus Infliximab 3 mg/kg i.v. Every 6 Weeks in Rheumatoid Arthritis Patients With Unsustainable Clinical Response to Infliximab 3 mg/kg Every 8 Weeks
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
January 2009 (Anticipated)
Study Completion Date
June 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hvidovre University Hospital
Collaborators
University Hospital, Gentofte, Copenhagen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Infliximab
Other Intervention Name(s)
remicade
Intervention Description
Remicade
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira
Intervention Description
Humira
Primary Outcome Measure Information:
Title
Proportion of patients achieving combined good or moderate EULAR responses at week 24
Time Frame
six months
Secondary Outcome Measure Information:
Title
ACR20/50/70 response at week 2, 6, 12, 18 and 24
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henrik Skjodt, MD, PhD
Phone
3632 3311
Email
hskj@dadlnet.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Mikkel Ostergaard, MD, DMedSci
Email
mo@dadlnet.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Skjodt, MD, PhD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre Hospital
City
Copenhagen
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Skjodt, MD, PhD
Email
hskj@dadlnet.dk
First Name & Middle Initial & Last Name & Degree
Mikkel Ostergaard, MD, DMedSci
Email
mo@dadlnet.dk
Facility Name
Bispebjerg Hospital
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karsten, Asmussen
Email
drasmus@post8.tele.dk
Facility Name
Gentofte Amtssygehus
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ole Rintek, MD, DMedSci
Email
rintek@dadlnet.dk
Facility Name
Glostrup Hospital
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gorm Thamsborg, MD, DMedSci
Email
goth@glostruphosp.kbhamt.dk
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Baslund, MD, PhD
Email
baslund@rh.dk
First Name & Middle Initial & Last Name & Degree
Annette Hansen, MD, PhD
Email
d263249@inet.uni2.dk
Facility Name
Graasten Gigthospital
City
Graasten
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lis S Andersen, MD, PhD
Email
lsandersen@gigtforeningen.dk

12. IPD Sharing Statement

Learn more about this trial

Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis

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