Rheumatoid ArthritisPhase 4NCT00216177
Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis
A Phase 4 study testing Infliximab and Adalimumab in people with Rheumatoid Arthritis, run by Hvidovre University Hospital at 6 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Infliximab and Adalimumab
- How many people
- 112 participants
- Where
- 6 sitesDenmark
- Study dates
- Sep 2005to Jun 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
Mikkel Ostergaard, MD, DMedSci contact
6 sites in 1 country
Denmark6 sites, 6 recruiting
- Recruiting
Hvidovre Hospital
Copenhagen, 2650
Henrik Skjodt, MD, PhD, hskj@dadlnet.dk
Mikkel Ostergaard, MD, DMedSci, mo@dadlnet.dk
- Recruiting
Bispebjerg Hospital
Copenhagen
Karsten, Asmussen, drasmus@post8.tele.dk
- Recruiting
Gentofte Amtssygehus
Copenhagen
Ole Rintek, MD, DMedSci, rintek@dadlnet.dk
- Recruiting
Glostrup Hospital
Copenhagen
Gorm Thamsborg, MD, DMedSci, goth@glostruphosp.kbhamt.dk
- Recruiting
Rigshospitalet
Copenhagen
Bo Baslund, MD, PhD, baslund@rh.dk
Annette Hansen, MD, PhD, d263249@inet.uni2.dk
- Recruiting
Graasten Gigthospital
Gråsten
Lis S Andersen, MD, PhD, lsandersen@gigtforeningen.dk
About this study
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
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Infliximab, Adalimumab
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Also called remicade
Remicade
AdalimumabDrug
Also called Humira
Humira
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving combined good or moderate EULAR responses at week 24
Measured: six months
Secondary outcomes (1)
ACR20/50/70 response at week 2, 6, 12, 18 and 24
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJan 2009 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen
- Investigators
- Henrik Skjodt, MD, PhD, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216177
- Sponsor's protocol ID
- 232-003
- Other IDs
- EudraCT no: 2005-001633-14, Switch/HUM 05-001
- Status last verified
- Aug 2009
- First submitted
- 20 Sep 2005
- Last updated
- 18 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00216177
- Acronym / sponsor ID
- 232-003
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen
- Study start
- Sep 2005
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InfliximabAlso: remicadeRemicade | Drug | – |
| AdalimumabAlso: HumiraHumira | Drug | – |
Primary outcome
Proportion of patients achieving combined good or moderate EULAR responses at week 24
Time frame: six months
1 secondary outcome
ACR20/50/70 response at week 2, 6, 12, 18 and 24
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikkel Ostergaard, MD, DMedSci contact
Henrik Skjodt, MD, PhD principal investigator
Hvidovre University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infliximab and Adalimumab in people with Rheumatoid Arthritis, run by Hvidovre University Hospital at 6 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henrik Skjodt, MD, PhD (3632 3311, hskj@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving combined good or moderate EULAR responses at week 24 (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2009.