Rheumatoid ArthritisPhase 4NCT01270087
The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.
A Phase 4 study testing Adalimumab in people with Rheumatoid Arthritis, run by Skane University Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether anti-inflammatory treatment with adalimumab (Humira) reduces endothelial activation in blood vessels in patients with active rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSweden
- Study dates
- May 2005to Feb 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of rheumatoid arthritis
- Fulfillment of the American College of Rheumatology 1987 criteria for rheumatoid arthritis
- Active disease despite treatment with at least one disease modifying anti-rheumatic drug
- Treatment with adalimumab indicated according to the the patient's rheumatologist
- At least six swollen joints in 28-joint index
- CRP > 8 mg / L within the last three months
Who cannot join
- Treatment with anti-TNF drugs in the last three months
- Treatment with intravenous corticosteroids within fourteen days
- Ongoing treatment with oral high-dose corticosteroids (equivalent to ≥ 20 mg of prednisolon daily) or completed such treatment less than fifteen days before inclusion
- Severe bleeding disorder
- Extensive or refractory leg ulcers
- Severe peripheral vascular disease
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Rheumatology, Skåne University Hospital
Malmö, 205 02
About this study
The purpose of this study is to determine whether anti-inflammatory treatment with adalimumab (Humira) reduces endothelial activation in blood vessels in patients with active rheumatoid arthritis. Markers of endothelial activation are assessed in muscle tissue before treatment and after 3 months, and related to other biomarkers and clinical outcomes.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Adalimumab
- Keywords
- Rheumatoid arthritis, cardiovascular disease, adalimumab
- Medical subject headings
- Arthritis, Rheumatoid, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Also called Humira
40 mg IV every 14 days
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Other | Not described Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial expression of HLA-DQ in muscle biopsies
Vascular tissue area stained for HLA-DQ by immunohistochemistry, quantified by computer assisted image analysis
Measured: 3 months
Endothelial expression of interleukin-1 alpha in muscle biopsies
Vascular tissue area stained for interleukin-1 alpha by immunohistochemistry, quantified by computer assisted image analysis
Measured: 3 months
Carotid artery intima-media thickness
Thickness of the intima and media of the common carotid artery, measured by ultrasound. Mean of two measures of the right and left common carotid artery.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startMay 2005
- Primary completionFeb 2007
- Study completionFeb 2007
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, The Swedish Research Council, The Swedish Rheumatism Ass, Crafoord Foundation
- Investigators
- Carl Turesson, MD, PhD, Principal investigator, Department of Rheumatology, Skåne University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270087
- Sponsor's protocol ID
- REUMAUMAS 2005-1
- Other IDs
- 2005-000129-47, 2005
- Status last verified
- Jan 2007
- First submitted
- 4 Jan 2011
- Last updated
- 5 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.
- ClinicalTrials.gov ID
- NCT01270087
- Acronym / sponsor ID
- REUMAUMAS 2005-1
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, cardiovascular disease, adalimumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Collaborators
- Abbott, The Swedish Research Council, The Swedish Rheumatism Ass, Crafoord Foundation
- Study start
- May 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 5 Jan 2011 (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 determine whether anti-inflammatory treatment with adalimumab (Humira) reduces endothelial activation in blood vessels in patients with active rheumatoid arthritis. Markers of endothelial activation are assessed in muscle tissue before treatment and after 3 months, and related to other biomarkers and clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | Other | Drug: Adalimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of rheumatoid arthritis
- Fulfillment of the American College of Rheumatology 1987 criteria for rheumatoid arthritis
- Active disease despite treatment with at least one disease modifying anti-rheumatic drug
- Treatment with adalimumab indicated according to the the patient's rheumatologist
- At least six swollen joints in 28-joint index
Key exclusion criteria (6 listed)
- Treatment with anti-TNF drugs in the last three months
- Treatment with intravenous corticosteroids within fourteen days
- Ongoing treatment with oral high-dose corticosteroids (equivalent to ≥ 20 mg of prednisolon daily) or completed such treatment less than fifteen days before inclusion
- Severe bleeding disorder
- Extensive or refractory leg ulcers
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 |
|---|---|---|
| AdalimumabAlso: Humira40 mg IV every 14 days | Drug | Adalimumab |
Primary outcome
Endothelial expression of HLA-DQ in muscle biopsies
Time frame: 3 months
Vascular tissue area stained for HLA-DQ by immunohistochemistry, quantified by computer assisted image analysis
Endothelial expression of interleukin-1 alpha in muscle biopsies
Time frame: 3 months
Vascular tissue area stained for interleukin-1 alpha by immunohistochemistry, quantified by computer assisted image analysis
Carotid artery intima-media thickness
Time frame: 3 months
Thickness of the intima and media of the common carotid artery, measured by ultrasound. Mean of two measures of the right and left common carotid artery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2011.
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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.
Carl Turesson, MD, PhD principal investigator
Department of Rheumatology, Skåne University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adalimumab in people with Rheumatoid Arthritis, run by Skane University Hospital at 1 site in Sweden.
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 6 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: finished, as of the sponsor's last update on 5 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial expression of HLA-DQ in muscle biopsies (time frame: 3 months). The study lists 3 primary outcomes in all. 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 5 Jan 2011.