Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis
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
3 other identifiers
interventional
112
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 rheumatoid-arthritis
Started Sep 2005
Typical duration for phase_4 rheumatoid-arthritis
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 20, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedAugust 18, 2009
August 1, 2009
3.3 years
September 20, 2005
August 17, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients achieving combined good or moderate EULAR responses at week 24
six months
Secondary Outcomes (1)
ACR20/50/70 response at week 2, 6, 12, 18 and 24
six months
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Hvidovre Hospital
Copenhagen, 2650, Denmark
Bispebjerg Hospital
Copenhagen, Denmark
Gentofte Amtssygehus
Copenhagen, Denmark
Glostrup Hospital
Copenhagen, Denmark
Rigshospitalet
Copenhagen, Denmark
Graasten Gigthospital
Gråsten, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henrik Skjodt, MD, PhD
Hvidovre University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 20, 2005
First Posted
September 22, 2005
Study Start
September 1, 2005
Primary Completion
January 1, 2009
Study Completion
June 1, 2009
Last Updated
August 18, 2009
Record last verified: 2009-08