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Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00216177
Recruitment Status : Unknown
Verified August 2009 by Hvidovre University Hospital.
Recruitment status was:  Recruiting
First Posted : September 22, 2005
Last Update Posted : August 18, 2009
Sponsor:
Collaborator:
University Hospital, Gentofte, Copenhagen
Information provided by:
Hvidovre University Hospital

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Infliximab Drug: Adalimumab Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2005
Estimated Primary Completion Date : January 2009
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Infliximab
    Remicade
    Other Name: remicade
  • Drug: Adalimumab
    Humira
    Other Name: Humira


Primary Outcome Measures :
  1. Proportion of patients achieving combined good or moderate EULAR responses at week 24 [ Time Frame: six months ]

Secondary Outcome Measures :
  1. ACR20/50/70 response at week 2, 6, 12, 18 and 24 [ Time Frame: six months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00216177


Contacts
Contact: Henrik Skjodt, MD, PhD 3632 3311 hskj@dadlnet.dk
Contact: Mikkel Ostergaard, MD, DMedSci mo@dadlnet.dk

Locations
Denmark
Hvidovre Hospital Recruiting
Copenhagen, Denmark, 2650
Contact: Henrik Skjodt, MD, PhD       hskj@dadlnet.dk   
Contact: Mikkel Ostergaard, MD, DMedSci       mo@dadlnet.dk   
Bispebjerg Hospital Recruiting
Copenhagen, Denmark
Contact: Karsten , Asmussen       drasmus@post8.tele.dk   
Gentofte Amtssygehus Recruiting
Copenhagen, Denmark
Contact: Ole Rintek, MD, DMedSci       rintek@dadlnet.dk   
Glostrup Hospital Recruiting
Copenhagen, Denmark
Contact: Gorm Thamsborg, MD, DMedSci       goth@glostruphosp.kbhamt.dk   
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Bo Baslund, MD, PhD       baslund@rh.dk   
Contact: Annette Hansen, MD, PhD       d263249@inet.uni2.dk   
Graasten Gigthospital Recruiting
Graasten, Denmark
Contact: Lis S Andersen, MD, PhD       lsandersen@gigtforeningen.dk   
Sponsors and Collaborators
Hvidovre University Hospital
University Hospital, Gentofte, Copenhagen
Investigators
Principal Investigator: Henrik Skjodt, MD, PhD Hvidovre University Hospital

Responsible Party: Henrik Skjodt, Hvidovre Hospital
ClinicalTrials.gov Identifier: NCT00216177     History of Changes
Other Study ID Numbers: 232-003
EudraCT no: 2005-001633-14
Switch/HUM 05-001
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: August 18, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Infliximab
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents